%22%2F%3E%0A%3Cdefs%3E%0A%3Cpattern%20id%3D%22pattern0%22%20patternContentUnits%3D%22objectBoundingBox%22%20width%3D%221%22%20height%3D%221%22%3E%0A%3Cuse%20xlink%3Ahref%3D%22%23image0_10319_58637%22%20transform%3D%22scale(0.00350877%200.0142857)%22%2F%3E%0A%3C%2Fpattern%3E%0A%3Cimage%20id%3D%22image0_10319_58637%22%20width%3D%22285%22%20height%3D%2270%22%20xlink%3Ahref%3D%22data%3Aimage%2Fpng%3Bbase64%2CiVBORw0KGgoAAAANSUhEUgAAAR0AAABGCAYAAADxVED7AAAAAXNSR0IArs4c6QAAE2xJREFUeF7tXY3xJUUR38nAIwHFBBQTQEhAMAE5E1BMQDABIAG9iwCMgCMCIQGBCCCDsX7r9FZvb%2Fd0z%2B68938cvVVXd3Vvdz56en7T31OWfJICSYGfNQVqrb8FAUopX9%2BDEOUenWQfSYGkwGNRoNb6i2VZ%2FrIsy1%2BXZcG%2F8fy4LMunpZSPbznaBJ1bUjfbTgo8IAVqrQCbjxjYyFG%2BKKU8v9XQE3RuRdlsNynwYBRo0s0ny7J8EBjaB6WUl4H3hl9J0BkmWX6QFPjpUaDW%2BqtlWb5clgV%2FR56vSylvRV4cfSdBZ5Ri%2BX5S4CdGgROAQzN8p5TyavZ0E3RmUzTbSwo8EAUuAA5m8VkpBYbmqU%2BCzlRyZmNJgcehwEXAwURelVLemT2jBJ3ZFM32kgIPQIEJgINZ%2FFhKeTZ7Ogk6syma7SUFnpgCkwCHZvFmKeW7mVNK0JlJzWwrKfDEFJgMOJjN81LKi5nTStCZSc1sKynwhBRocTj%2FGXCLR0b7YSnl08iL0XcSdKKUyveSAg9OgVorAGfNowo8ny3LAgnmcwekpkcnJ%2BgEVidfSQo8OgVqrYg0jrq3N%2Bml1opv8K31%2FLuU8t7M%2BSfozKRmtpUUeAIK1Fr%2F3nKpvN6R0AnA2Ww0tVYACqQd65kemZyg4y1T%2Fp4UeGAKtOTNqM3lLVm%2Bohmev%2B1M8btSypszSZCgM5Oa2VZS4I4UqLX%2BvuVTRXo1vVC11tppYHqsToJOZLnynaTAg1Fg0DXedXvXWiHpmImgpZSpODG1sQdblxxOUuC1pMBMwAGBaq3IPofUpD4JOq8lG%2BWkkgJxCgy4xkOBfbVWGJb%2F1BnB1KjklHTia51vJgWenAIDnqoQ4DRJB1UE4QGzngSdJ1%2F5HEBS4Ako4HiqIK1slf5G6uAEYnUSdJ5gvbPLpMCTUqDd2ICIY%2B1BIfUflLrHuN0BsTnfLMuCb7%2FXwKjWivKl%2F%2BpM8OBqv0KMVK%2BuUC%2B%2FTQrcgQIBwzHKilqApI0QYPQV6uUsy0LABBXrN4ZBeWoFwQSdOzBNdpEUuEIBz7u0LAuC93oBfl73KF0BAMIfSEVwnyNS%2Be327wQdj4L5e1LgdaFA0HCMQlsAHbq%2FCvlU%2BBMtwi7JRZLQF%2B0HRCVPq6mTks7rwp05j9eOAoEUBcx59VLVWpEKgfus8Kw2mBaxDHtNzx3u0Y2kICR%2BEgh533R%2FT9C5RL78OClwGwoEa%2BNsbnGREvFxKQU2mvVp4IXgP7jFz0o%2FaApGaQDPJQBK0LkNz2SrSYFLFAiUqjjE4TDbD8ABbm78vXsmST8cgF6OuOfxYYLOJdbIj5MC8ynguMc3lUoBFEgxZFDeSTvGu6R6XZF%2B0DSpYLiyBvagVK88IuTvSYFHokAnAfNQD0cBE7Lt4F3YdlwDcIvTgd3HzL8aoA9c9wAf80rilHQGqJmvJgVuTYFOoB5ABK7rriQhbEFflFLej4y52X3wKmxBVwzP1B0kLkhbB%2FBJ0ImsSL6TFLgTBQwpJwQ4NERRDTAUY1NrJbBZDcVN6gH4XFW9kMH%2BZy5xJejciZmym6SARwGjKNcQ4DDgQQlSBPhBvYKadTAq8%2FEoEhZyuVC8HYXe4YqPFnzXpgmp510CngQdjxPy96TAnSjQpA2Z7d01CFtDG1WzOmrderVwA0SAz9ki7RvwJOjciaGym6SARwGjSPqnpZQPvW%2B134Xk1L2%2FqlP6dFcjudl%2Bztp9viylvJugc2Y185ukwI0oYORZfVRKQSb58MMilbverI6bfpV0ZMcNpJCZPmLzQS3mNxJ0hpcxP0gK3JYChpoF2wyMwq4LXAEIKkdq2nc6KRdwf6v3adVagR8Anqi3C6Dzu2HQaciJFHh6IH49v%2B0yjLfedFoQ45vRiMnx3q5%2F0cbbu3%2FobCeo5h9ym57tIL%2BbT4GOGgMDL%2Bw8YfARpTFUN3oHdDy1DBnu%2Fw1SYBx0OgN75lnHg4O6%2FFobI8AG6Iys23DZxsudX2ggmNx3pofp9xadGUR%2Bc44CHfAZUrma%2BgSJB3vi8G2H%2F0yXe5N0%2FrksCyKbI8%2B3pZRfD0k6nbKGpyzskVGOvqMUmU7QmXxZ2uia5PvXKWCAD6QdAIgZ%2Fct7Fh6qHfCMChRMMh%2BJYl5xYhR0rPtxVGPTdVKPt5Cgc6BZSjrjbPSwX3TAB4crinB1H2Ev2oDH8F6pVwqfNCKvUg4GFwadwG2CochHjyhXf%2F%2Bpgs7VeeP7xpDIfaFiTvjvh5FCZ8wx2%2Fg%2FBQzwCdl7BPBAWoKk9AclAHBnz2nSDeKIVMNyZ23OBQcqmxk5IDxK8SGY%2B%2BcKOkb9lYeRQBMsbkOBs%2BBjeMjkILdbIE5KN2hvBzhhSacxNKrN80fWZb1853EjIPz%2B%2BIO4AvyBiNcN4RZ6q7w47G42nTZ%2BADFJGuscImLvVZZUwHbYxdqMjaA9xo%2Fvp5apvDpH%2Bb2gN8YLWrulFbxxNH4HHehQPcWL1I%2FSHn5Cm6Dv5fEakg%2Fo8aIX3%2BMAySpEXJBuVMAZAR15RQUm81wJZBpWsdrEEVoNjxNXCzhvYGEQmXkwmLWNwkOzpZiIBDYUm6YHILaVXWzGcd4v%2BtlAro0PY1vBpAijbFsUhIeTt0zjaaq4NuTq9DYHY2r0j5IG%2FAmtBZsfaKjRfzVWtmpxKvi3zc89GBuNWegC2peADBsEXLghQyjbXNw7KclEtV2Gad1oAfWhZxzFmMH%2F7pgbXcAXPd7GeLF2qMYXdoNbvKFIPq6xmZW2ANASWL1s92xh7a192WNRHP5Qzw48E7LpWOCieLNWMBrYLJ8M6oeH0ztwZ48czm6MSlbvKlJapwC%2F17kBHmJrRqIyzcWI0k1IdrxwE%2F3kqroNDBDYFc2lAe3f105mxd5HhxI2byRqNWqLALiObIKQW7ltVIxzxBPTlSRPbFi0h0A8eXicYQvN5uOCDzvEqLTpCD3oc2hE%2F%2BjNwwUdxZW2eUMa4%2FIq9GaZREU01gCHJAK8DnTFySg39C7r9hag006mrcYsHzuBTucuIpyEdGJZc5hiazHG4LbdGTskShL3QXeN6T6Qp7wGOq08wkiwYzcbutYKUJDxICTVYIlIHZKnchd4nHWEhEwnNQJiJUCrGeDGDQ54F7xB7Vn07QbjjSKQAqhYX%2FRx8HRdVKUwtEMZC228EdCRNhIpKVCINbXv2lAUoMBC4LtDtfn2LgCKM9PGoC1JjqrgE%2FNxoFptE2zyEOeRsr8%2BiqSD6F1zszDQkeEDWExIAgcR2YhvOmzeEwxF5Qvo05AdR5mzyoiGkfKQw6OADhhaU6XwrQXEmIOa3KjUC8Y8VRexYSBVaW0ATq9t8BVozh0oO3oY8S7gN4DfTtVo74K3OZiFD%2B4RflEk9510eUIy49270s3u4PYGbqkfbNNKe0%2FkpJVA1d2AwhWMDYIiQzvbCxvPkCFZmR9tDDRJfeFvMlSuoCJKPHZP6fa%2BvKRejYHw1oPNE7YHKY25dhzlFMbc8J1prFc28m6NO%2BEUaBMb7rBWHSPmbg7KAeUCq3GoHQqVnzG%2BN2kA%2FEvAA4CF5LBKiI1X%2Bc0LrslBMV%2B46nGUTxQNA%2FuVboVY16apwGdUqbB0EwYdJdX%2BsFEUFQvtd9Miaq3IwaAn5PVqY3E9QaMu80492pCYSx4U704gg06nLqY3MoJdRjVO4dAYaq2I%2F%2BEn%2FAYOZ4tPGZLGLsFQWZ%2BQhKjwgXYti7wVM0oLbFD8UQ8%2BdjBAgsGe6RqIlX3mHtxnQYeNDWsJp0vPAdLrBgcKaDpsg%2BqqV8rCWWKqlC68SvTDoBMl8iTQCQFOdExsoaWE914pBVJb%2BDlrx2mnMBgM4jw97inMxm5%2Ba4BOiIaK6gkvzqpuKO2Go6u9bxU%2BuflGtxZZCUkJHcRhphEvtkMLNrKz1QAh3UG9PeVtM0Fn5FTUdHqtBgdjYOiA3EYT8jJEiDwBdG7GfKNj0%2BariOKuusHoLqWVMOgp%2FLBtDG%2BD99ZNaXeTpsWtlWjGLLNg0Era3Xiwm%2FwtJEFFePDMO0L6X7iX9Ex7HYAb9QDypkzb68gYe6AjbTXbCWQssASSXnaqPPHR5FqT9Wqw1OjGPiu%2BjxCZbfohe5Psw%2FCKuHacJjUA5GWA51B1gFqrXGMeXoA1pafLK8q8uOTLvaOST0JzZfSWhna6ghcnPACYPyHV6sy6R76RfDgbdE6GBfChq8bwyNzkOz3QGToJRk4lJ4%2BLLm9fXc%2BjIDQBdNZ7oM8QU9lMFN1Lf8u7hVxPH9tAUDmkV82147Dv5UbDqTVaZ0fG3KySkhWnE6WhOOU56EiQQwzYiEgvA%2F1WSUkzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
Study of Asian patients with Hypercholesterolaemia in the UK - Rosuvastatin 5mg versus Atorvastatin 10mg
Study identifier:D3560L00060
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A phase IV, 6-week, randomised, double-blind, multicentre, parallel group, comparative study to evaluate the efficacy of rosuvastatin 5mg and atorvastatin 10mg in UK Asian subjects with primary hypercholesterolaemia
Medical condition
hypercholesterolaemia
Phase
Phase 4
Healthy volunteers
No
Study drug
rosuvastatin, atorvastatin
Sex
All
Actual Enrollment
55
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Dec 2006
Primary Completion Date: 01 Feb 2008
Study Completion Date: 01 Feb 2008
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2010 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
BLACKBURN, United Kingdom
Location
Research Site
CRAWLEY, United Kingdom
Location
Research Site
ALLERTON, United Kingdom
Location
Research Site
BIRMINGHAM, United Kingdom
Location
Research Site
BOLTON, United Kingdom
Location
Research SIte
GLASGOW, United Kingdom
Location
Research Site
NEWCASTLE, United Kingdom
Location
Research SIte
SHEFFIELD, United Kingdom
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: rosuvastatin rosuvastatin 5 mg | Drug: rosuvastatin rosuvastatin 5 mg Other Name: Crestor |
| Active Comparator: atorvastatin atorvastatin 10 mg | Drug: atorvastatin atorvastatin 10 mg |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Participants were recruited from 25 primary and secondary care centres in the United Kingdom. The first participant was enrolled on 20th December 2006 and the last participant entered the study on 16th November 2007. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Participants entered an initial 6-week dietary run-in/ wash-out period, after which those with a fasting low density lipoprotein cholesterol (LDL-C) of greater than or equal to 4.00 mmol/L and triglycerides (TG) less than 4.52 mmol/L, were randomised to receive treatment with either rosuvastatin 5 mg plus atorvatstatin , or atorvastatin 10mg |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Participant Flow: Overall Study
| rosuvastatin | atorvastatin | |
|---|---|---|
| STARTED | 30 | 25 |
| COMPLETED | 28 | 21 |
| NOT COMPLETED | 2 | 4 |
| Adverse Event | 2 | 0 |
| Withdrawal by Subject | 0 | 3 |
| Not Specified | 0 | 1 |
Baseline Characteristics
Analysis Population Description -- Explanation of how the number of participants for analysis was determined.
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Baseline Measures
| rosuvastatin | atorvastatin | Total | |
|---|---|---|---|
|
Number of Participants
[units: Participants] |
30 | 25 | 55.0 |
| Age Continuous [units: years] Mean ± Standard Deviation |
50 ± 11 | 53 ± 11 | 51.5 ± 11 |
| Gender, Male/Female [units: participants] |
|||
| Female | 13 | 11 | 24 |
| Male | 17 | 14 | 31 |
Outcome Measures
1. Primary Outcome Measure: Percentage change in Low Density Lipoprotein - Cholesterol (LDL-C) [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Primary |
|---|---|
| Measure Name | Percentage change in Low Density Lipoprotein - Cholesterol (LDL-C) |
| Measure Description | Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100 |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| Percentage change in Low Density Lipoprotein - Cholesterol (LDL-C) [units: Percent Change in LDL-C] |
33.28 | 36.92 |
No statistical analysis provided for Percentage change in Low Density Lipoprotein - Cholesterol (LDL-C)
2. Secondary Outcome Measure: The percentage of participants reaching the General Medical Services (GMS) contract target of total cholesterol (TC) <5 mmol/L [ Time Frame: 6 weeks (Baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage of participants reaching the General Medical Services (GMS) contract target of total cholesterol (TC) <5 mmol/L |
| Measure Description | |
| Time Frame | 6 weeks (Baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage of participants reaching the General Medical Services (GMS) contract target of total cholesterol (TC) <5 mmol/L [units: Percentage of Participants] |
50 | 64 |
No statistical analysis provided for The percentage of participants reaching the General Medical Services (GMS) contract target of total cholesterol (TC) <5 mmol/L
3. Secondary Outcome Measure: The percentage of participants reaching the Joint British Societies’ Guideline (JBS 2) targets of TC <4 mmol/L and LDL-C <2 mmol/L [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage of participants reaching the Joint British Societies’ Guideline (JBS 2) targets of TC <4 mmol/L and LDL-C <2 mmol/L |
| Measure Description | |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage of participants reaching the Joint British Societies’ Guideline (JBS 2) targets of TC <4 mmol/L and LDL-C <2 mmol/L [units: Percentage of Participants] |
16 | 28 |
No statistical analysis provided for The percentage of participants reaching the Joint British Societies’ Guideline (JBS 2) targets of TC <4 mmol/L and LDL-C <2 mmol/L
4. Secondary Outcome Measure: The percentage of participants reaching the European (EAS) targets of LDL-C<2.5 or 3.00 mmol/L, depending on risk category, and the combined LDL-C and TC target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, both depending on risk category. [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage of participants reaching the European (EAS) targets of LDL-C<2.5 or 3.00 mmol/L, depending on risk category, and the combined LDL-C and TC target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, both depending on risk category. |
| Measure Description | Risk categories are: Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L Patients are defined as symptomatic if they meet at least 1 of the following criteria: History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg Total risk is derived from age, sex, TC, systolic BP and smoking status. |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage of participants reaching the European (EAS) targets of LDL-C<2.5 or 3.00 mmol/L, depending on risk category, and the combined LDL-C and TC target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, both depending on risk category. [units: Percentage of Participants] |
43 | 48 |
No statistical analysis provided for The percentage of participants reaching the European (EAS) targets of LDL-C<2.5 or 3.00 mmol/L, depending on risk category, and the combined LDL-C and TC target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, both depending on risk category.
5. Secondary Outcome Measure: The percentage change from baseline(week6) in TC [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage change from baseline(week6) in TC |
| Measure Description | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage change from baseline(week6) in TC [units: Percent Change in TC] |
-23.03 | -26.88 |
No statistical analysis provided for The percentage change from baseline(week6) in TC
6. Secondary Outcome Measure: The percentage change from baseline (week 6) in high-density lipoprotein cholesterol (HDL-C) [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage change from baseline (week 6) in high-density lipoprotein cholesterol (HDL-C) |
| Measure Description | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage change from baseline (week 6) in high-density lipoprotein cholesterol (HDL-C) [units: Percent Change in HDL-C] |
4.46 | 3.15 |
No statistical analysis provided for The percentage change from baseline (week 6) in high-density lipoprotein cholesterol (HDL-C)
7. Secondary Outcome Measure: The percentage of participants reaching the Joint British Societies Guideline (JBS 2) target of TC <4 mmol/L [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage of participants reaching the Joint British Societies Guideline (JBS 2) target of TC <4 mmol/L |
| Measure Description | |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage of participants reaching the Joint British Societies Guideline (JBS 2) target of TC <4 mmol/L [units: Percentage of Participants] |
13 | 12 |
No statistical analysis provided for The percentage of participants reaching the Joint British Societies Guideline (JBS 2) target of TC <4 mmol/L
8. Secondary Outcome Measure: The percentage change from baseline (week 6)in non-HDL-C [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage change from baseline (week 6)in non-HDL-C |
| Measure Description | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage change from baseline (week 6)in non-HDL-C [units: Percent Change in Non-HDL-C] |
-29.72 | -34.09 |
No statistical analysis provided for The percentage change from baseline (week 6)in non-HDL-C
9. Secondary Outcome Measure: The percentage change from baseline (week 6) in apolipoprotein-B (ApoB) [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage change from baseline (week 6) in apolipoprotein-B (ApoB) |
| Measure Description | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage change from baseline (week 6) in apolipoprotein-B (ApoB) [units: Percent Change in ApoB] |
-25.96 | -28.67 |
No statistical analysis provided for The percentage change from baseline (week 6) in apolipoprotein-B (ApoB)
10. Secondary Outcome Measure: The percentage change from baseline (week 6) in apolipoprotein-A1 (ApoA1) [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage change from baseline (week 6) in apolipoprotein-A1 (ApoA1) |
| Measure Description | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage change from baseline (week 6) in apolipoprotein-A1 (ApoA1) [units: Percent Change in ApoA1] |
-0.55 | 1.89 |
No statistical analysis provided for The percentage change from baseline (week 6) in apolipoprotein-A1 (ApoA1)
11. Secondary Outcome Measure: The percentage change from baseline (week 6)in LDL-C/HDL-C ratio [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage change from baseline (week 6)in LDL-C/HDL-C ratio |
| Measure Description | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage change from baseline (week 6)in LDL-C/HDL-C ratio [units: Percent Change in LDL-C/HDL-C Ratio] |
-34.75 | -38.45 |
No statistical analysis provided for The percentage change from baseline (week 6)in LDL-C/HDL-C ratio
12. Secondary Outcome Measure: The percentage change from baseline (week 6) in TC/HDL-C ratio [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage change from baseline (week 6) in TC/HDL-C ratio |
| Measure Description | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage change from baseline (week 6) in TC/HDL-C ratio [units: Percent Change in TC/HDL-C Ratio] |
-24.99 | -28.42 |
No statistical analysis provided for The percentage change from baseline (week 6) in TC/HDL-C ratio
13. Secondary Outcome Measure: The percentage change from baseline(week 6) in non-HDL-C/HDL-C ratio [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage change from baseline(week 6) in non-HDL-C/HDL-C ratio |
| Measure Description | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage change from baseline(week 6) in non-HDL-C/HDL-C ratio [units: Percent Change in Non-HDL-C/HDL-C Ratio] |
-31.05 | -35.48 |
No statistical analysis provided for The percentage change from baseline(week 6) in non-HDL-C/HDL-C ratio
14. Secondary Outcome Measure: The percentage change from baseline (week 6) in ApoB/ApoA1 ratio [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage change from baseline (week 6) in ApoB/ApoA1 ratio |
| Measure Description | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage change from baseline (week 6) in ApoB/ApoA1 ratio [units: Percent Change in ApoB/ApoA1 Ratio] |
-22.89 | -28.75 |
No statistical analysis provided for The percentage change from baseline (week 6) in ApoB/ApoA1 ratio
15. Secondary Outcome Measure: The percentage of participants reaching the European (EAS) targets of LDL-C<2.5 or 3.00 mmol/L, depending on risk category. [ Time Frame: 6 weeks (baseline) and 12 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The percentage of participants reaching the European (EAS) targets of LDL-C<2.5 or 3.00 mmol/L, depending on risk category. |
| Measure Description | Risk categories are: Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L Patients are defined as symptomatic if they meet at least 1 of the following criteria: History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg Total risk is derived from age, sex, TC, systolic BP and smoking status. |
| Time Frame | 6 weeks (baseline) and 12 weeks |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intention to treat (ITT) population (all randomized patients). |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Measured Values
| rosuvastatin | atorvastatin | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
30 | 25 |
| The percentage of participants reaching the European (EAS) targets of LDL-C<2.5 or 3.00 mmol/L, depending on risk category. [units: Percentage of Participants] |
56.7 | 56.0 |
No statistical analysis provided for The percentage of participants reaching the European (EAS) targets of LDL-C<2.5 or 3.00 mmol/L, depending on risk category.
Serious Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Serious Adverse Events
| rosuvastatin | atorvastatin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total, serious adverse events | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 1/--- | 0/--- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Nervous system disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cerebrovascular Accident1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 1/--- | 0/--- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 5% |
|---|
Reporting Groups
| Description | |
|---|---|
| rosuvastatin | rosuvastatin 5 mg |
| atorvastatin | atorvastatin 10 mg |
Other Adverse Events
| rosuvastatin | atorvastatin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total, other (not including serious) adverse events | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 4/--- | 3/--- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Nervous system disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Dizziness1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 3/--- | 1/--- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Nervous system disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Headache1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 1/--- | 2/--- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Certain Agreements
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| The study achieved only 8% of the randomised target number of patients and for this reason alone was terminated early. Planned statistical analyses could not be performed. No scientifically valid conclusions can be drawn from the limited study data. |
Results Point of Contact
| Name/Title: | Gerard Lynch |
| Organization: | Astrazeneca |
| E-mail: | [email protected] |
Contacts
Investigators
Principal Investigator
Rhiannon Rowsell
AstraZeneca
%22%2F%3E%0A%3Cdefs%3E%0A%3Cpattern%20id%3D%22pattern0%22%20patternContentUnits%3D%22objectBoundingBox%22%20width%3D%221%22%20height%3D%221%22%3E%0A%3Cuse%20xlink%3Ahref%3D%22%23image0_8556_33445%22%20transform%3D%22translate(0%200.0591543)%20scale(0.00350877%200.0125956)%22%2F%3E%0A%3C%2Fpattern%3E%0A%3Cimage%20id%3D%22image0_8556_33445%22%20width%3D%22285%22%20height%3D%2270%22%20xlink%3Ahref%3D%22data%3Aimage%2Fpng%3Bbase64%2CiVBORw0KGgoAAAANSUhEUgAAAR0AAABGCAYAAADxVED7AAAAAXNSR0IArs4c6QAAE2xJREFUeF7tXY3xJUUR38nAIwHFBBQTQEhAMAE5E1BMQDABIAG9iwCMgCMCIQGBCCCDsX7r9FZvb%2Fd0z%2B68938cvVVXd3Vvdz56en7T31OWfJICSYGfNQVqrb8FAUopX9%2BDEOUenWQfSYGkwGNRoNb6i2VZ%2FrIsy1%2BXZcG%2F8fy4LMunpZSPbznaBJ1bUjfbTgo8IAVqrQCbjxjYyFG%2BKKU8v9XQE3RuRdlsNynwYBRo0s0ny7J8EBjaB6WUl4H3hl9J0BkmWX6QFPjpUaDW%2BqtlWb5clgV%2FR56vSylvRV4cfSdBZ5Ri%2BX5S4CdGgROAQzN8p5TyavZ0E3RmUzTbSwo8EAUuAA5m8VkpBYbmqU%2BCzlRyZmNJgcehwEXAwURelVLemT2jBJ3ZFM32kgIPQIEJgINZ%2FFhKeTZ7Ogk6syma7SUFnpgCkwCHZvFmKeW7mVNK0JlJzWwrKfDEFJgMOJjN81LKi5nTStCZSc1sKynwhBRocTj%2FGXCLR0b7YSnl08iL0XcSdKKUyveSAg9OgVorAGfNowo8ny3LAgnmcwekpkcnJ%2BgEVidfSQo8OgVqrYg0jrq3N%2Bml1opv8K31%2FLuU8t7M%2BSfozKRmtpUUeAIK1Fr%2F3nKpvN6R0AnA2Ww0tVYACqQd65kemZyg4y1T%2Fp4UeGAKtOTNqM3lLVm%2Bohmev%2B1M8btSypszSZCgM5Oa2VZS4I4UqLX%2BvuVTRXo1vVC11tppYHqsToJOZLnynaTAg1Fg0DXedXvXWiHpmImgpZSpODG1sQdblxxOUuC1pMBMwAGBaq3IPofUpD4JOq8lG%2BWkkgJxCgy4xkOBfbVWGJb%2F1BnB1KjklHTia51vJgWenAIDnqoQ4DRJB1UE4QGzngSdJ1%2F5HEBS4Ako4HiqIK1slf5G6uAEYnUSdJ5gvbPLpMCTUqDd2ICIY%2B1BIfUflLrHuN0BsTnfLMuCb7%2FXwKjWivKl%2F%2BpM8OBqv0KMVK%2BuUC%2B%2FTQrcgQIBwzHKilqApI0QYPQV6uUsy0LABBXrN4ZBeWoFwQSdOzBNdpEUuEIBz7u0LAuC93oBfl73KF0BAMIfSEVwnyNS%2Be327wQdj4L5e1LgdaFA0HCMQlsAHbq%2FCvlU%2BBMtwi7JRZLQF%2B0HRCVPq6mTks7rwp05j9eOAoEUBcx59VLVWpEKgfus8Kw2mBaxDHtNzx3u0Y2kICR%2BEgh533R%2FT9C5RL78OClwGwoEa%2BNsbnGREvFxKQU2mvVp4IXgP7jFz0o%2FaApGaQDPJQBK0LkNz2SrSYFLFAiUqjjE4TDbD8ABbm78vXsmST8cgF6OuOfxYYLOJdbIj5MC8ynguMc3lUoBFEgxZFDeSTvGu6R6XZF%2B0DSpYLiyBvagVK88IuTvSYFHokAnAfNQD0cBE7Lt4F3YdlwDcIvTgd3HzL8aoA9c9wAf80rilHQGqJmvJgVuTYFOoB5ABK7rriQhbEFflFLej4y52X3wKmxBVwzP1B0kLkhbB%2FBJ0ImsSL6TFLgTBQwpJwQ4NERRDTAUY1NrJbBZDcVN6gH4XFW9kMH%2BZy5xJejciZmym6SARwGjKNcQ4DDgQQlSBPhBvYKadTAq8%2FEoEhZyuVC8HYXe4YqPFnzXpgmp510CngQdjxPy96TAnSjQpA2Z7d01CFtDG1WzOmrderVwA0SAz9ki7RvwJOjciaGym6SARwGjSPqnpZQPvW%2B134Xk1L2%2FqlP6dFcjudl%2Bztp9viylvJugc2Y185ukwI0oYORZfVRKQSb58MMilbverI6bfpV0ZMcNpJCZPmLzQS3mNxJ0hpcxP0gK3JYChpoF2wyMwq4LXAEIKkdq2nc6KRdwf6v3adVagR8Anqi3C6Dzu2HQaciJFHh6IH49v%2B0yjLfedFoQ45vRiMnx3q5%2F0cbbu3%2FobCeo5h9ym57tIL%2BbT4GOGgMDL%2Bw8YfARpTFUN3oHdDy1DBnu%2Fw1SYBx0OgN75lnHg4O6%2FFobI8AG6Iys23DZxsudX2ggmNx3pofp9xadGUR%2Bc44CHfAZUrma%2BgSJB3vi8G2H%2F0yXe5N0%2FrksCyKbI8%2B3pZRfD0k6nbKGpyzskVGOvqMUmU7QmXxZ2uia5PvXKWCAD6QdAIgZ%2Fct7Fh6qHfCMChRMMh%2BJYl5xYhR0rPtxVGPTdVKPt5Cgc6BZSjrjbPSwX3TAB4crinB1H2Ev2oDH8F6pVwqfNCKvUg4GFwadwG2CochHjyhXf%2F%2Bpgs7VeeP7xpDIfaFiTvjvh5FCZ8wx2%2Fg%2FBQzwCdl7BPBAWoKk9AclAHBnz2nSDeKIVMNyZ23OBQcqmxk5IDxK8SGY%2B%2BcKOkb9lYeRQBMsbkOBs%2BBjeMjkILdbIE5KN2hvBzhhSacxNKrN80fWZb1853EjIPz%2B%2BIO4AvyBiNcN4RZ6q7w47G42nTZ%2BADFJGuscImLvVZZUwHbYxdqMjaA9xo%2Fvp5apvDpH%2Bb2gN8YLWrulFbxxNH4HHehQPcWL1I%2FSHn5Cm6Dv5fEakg%2Fo8aIX3%2BMAySpEXJBuVMAZAR15RQUm81wJZBpWsdrEEVoNjxNXCzhvYGEQmXkwmLWNwkOzpZiIBDYUm6YHILaVXWzGcd4v%2BtlAro0PY1vBpAijbFsUhIeTt0zjaaq4NuTq9DYHY2r0j5IG%2FAmtBZsfaKjRfzVWtmpxKvi3zc89GBuNWegC2peADBsEXLghQyjbXNw7KclEtV2Gad1oAfWhZxzFmMH%2F7pgbXcAXPd7GeLF2qMYXdoNbvKFIPq6xmZW2ANASWL1s92xh7a192WNRHP5Qzw48E7LpWOCieLNWMBrYLJ8M6oeH0ztwZ48czm6MSlbvKlJapwC%2F17kBHmJrRqIyzcWI0k1IdrxwE%2F3kqroNDBDYFc2lAe3f105mxd5HhxI2byRqNWqLALiObIKQW7ltVIxzxBPTlSRPbFi0h0A8eXicYQvN5uOCDzvEqLTpCD3oc2hE%2F%2BjNwwUdxZW2eUMa4%2FIq9GaZREU01gCHJAK8DnTFySg39C7r9hag006mrcYsHzuBTucuIpyEdGJZc5hiazHG4LbdGTskShL3QXeN6T6Qp7wGOq08wkiwYzcbutYKUJDxICTVYIlIHZKnchd4nHWEhEwnNQJiJUCrGeDGDQ54F7xB7Vn07QbjjSKQAqhYX%2FRx8HRdVKUwtEMZC228EdCRNhIpKVCINbXv2lAUoMBC4LtDtfn2LgCKM9PGoC1JjqrgE%2FNxoFptE2zyEOeRsr8%2BiqSD6F1zszDQkeEDWExIAgcR2YhvOmzeEwxF5Qvo05AdR5mzyoiGkfKQw6OADhhaU6XwrQXEmIOa3KjUC8Y8VRexYSBVaW0ATq9t8BVozh0oO3oY8S7gN4DfTtVo74K3OZiFD%2B4RflEk9510eUIy49270s3u4PYGbqkfbNNKe0%2FkpJVA1d2AwhWMDYIiQzvbCxvPkCFZmR9tDDRJfeFvMlSuoCJKPHZP6fa%2BvKRejYHw1oPNE7YHKY25dhzlFMbc8J1prFc28m6NO%2BEUaBMb7rBWHSPmbg7KAeUCq3GoHQqVnzG%2BN2kA%2FEvAA4CF5LBKiI1X%2Bc0LrslBMV%2B46nGUTxQNA%2FuVboVY16apwGdUqbB0EwYdJdX%2BsFEUFQvtd9Miaq3IwaAn5PVqY3E9QaMu80492pCYSx4U704gg06nLqY3MoJdRjVO4dAYaq2I%2F%2BEn%2FAYOZ4tPGZLGLsFQWZ%2BQhKjwgXYti7wVM0oLbFD8UQ8%2BdjBAgsGe6RqIlX3mHtxnQYeNDWsJp0vPAdLrBgcKaDpsg%2BqqV8rCWWKqlC68SvTDoBMl8iTQCQFOdExsoaWE914pBVJb%2BDlrx2mnMBgM4jw97inMxm5%2Ba4BOiIaK6gkvzqpuKO2Go6u9bxU%2BuflGtxZZCUkJHcRhphEvtkMLNrKz1QAh3UG9PeVtM0Fn5FTUdHqtBgdjYOiA3EYT8jJEiDwBdG7GfKNj0%2BariOKuusHoLqWVMOgp%2FLBtDG%2BD99ZNaXeTpsWtlWjGLLNg0Era3Xiwm%2FwtJEFFePDMO0L6X7iX9Ex7HYAb9QDypkzb68gYe6AjbTXbCWQssASSXnaqPPHR5FqT9Wqw1OjGPiu%2BjxCZbfohe5Psw%2FCKuHacJjUA5GWA51B1gFqrXGMeXoA1pafLK8q8uOTLvaOST0JzZfSWhna6ghcnPACYPyHV6sy6R76RfDgbdE6GBfChq8bwyNzkOz3QGToJRk4lJ4%2BLLm9fXc%2BjIDQBdNZ7oM8QU9lMFN1Lf8u7hVxPH9tAUDmkV82147Dv5UbDqTVaZ0fG3KySkhWnE6WhOOU56EiQQwzYiEgvA%2F1WSUkzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
