DISCOVERY Asia - Crestor in Type IIa and IIb hypercholesteremia

Study identifier:D3560L00009

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

: An open-label, randomised, multi-centre, phase IIIb/IV, parallel group study to compare the efficacy and safety of rosuvastatin and atorvastatin in subjects with type IIa and IIb hypercholesterolaemia (DISCOVERY)

Medical condition

Hypercholesterolemia

Phase

Phase 3

Healthy volunteers

Study drug

Rosuvastatin

Sex

All

Actual Enrollment

1362

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jun 2003

Primary Completion Date: 01 Dec 2005

Study Completion Date: 01 Feb 2007

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Visit 1:
1. Written informed consent to participate in the trial (Appendix B)
2. Male or female subjects, age > 18 years
3. Primary hypercholesterolaemia with CV risk > 20%/10yrs, type 2 diabetes, a history of CHD or other established atherosclerotic disease (definition given in Appendix L).
4. Subjects may be lipid-lowering therapy-naïve, but have completed 6-weeks dietary counselling before this visit OR
Subjects may be treated with the ‘start’ dose of other lipid lowering therapy, which is ineffective, ie. The subject has not met LDL-C treatment goals.
5. Subjects willing to follow all study procedures including attendance at clinics for scheduled study visits, fasting prior to blood draws and compliance with study treatment regimen
Visit 2:
6. Subjects switched from start dose of a lipid lowering therapy (commonly accepted start dose) will have fasting LDL-C levels > 3.1 mmol (120 mg/dl)
7. Newly treated subjects, after a six-weeks dietary counselling, will have fasting LDL-C levels > 3.5 mmol/L (135 mg/dL)
8. Fasting triglycerides £ 4.52 mmol/L (400 mg/dL)
9. Switched patients must stop current lipid lowering treatment at randomisation (Visit 2)

Exclusion Criteria

1. Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
2. Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria 3
3. History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy
4. Unstable angina within three months prior to inclusion in the study
5. Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT ³ 1.5 times the ULN. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the subject must not be included in the study
6. Known uncontrolled diabetes
7. Uncontrolled hypertension defined as either resting diastolic blood pressure of > 95mmHg or resting systolic blood pressure of > 200 mmHg
8. Unexplained serum CK > 3 times ULN (eg not due to recent trauma, intramuscular injections, heavy exercise etc)
9. Serum creatinine > 220 µmol/L (2.5mg/dL)

No locations available

Arms	Assigned Interventions

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1348&filename=CSR-d3560l00009.pdf
Download
CSR-d3560l00009.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca China Information Center

+86 21 525 645 55

[email protected]

Investigators

Principal Investigator

AstraZeneca China Medical Director

AstraZeneca