EU Clinical Trial Information System (CTIS)

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.

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Official Title

To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction

Investigate the effect of AZD1305 on patients with left ventricular dysfunction

iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes

Research Site

A single-centre, single-blind, randomised, placebo-controlled phase IIa study to investigate the effect of AZD1305 given as an intravenous (iv) infusion on left ventricular performance in patients with left ventricular dysfunction

To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.

Age Continuous

Gender, Male/Female

Left ventricular ejection fraction (LVEF), change from baseline

To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction.

Number of subjects with at least one reported Adverse Event during each study period and in each dose group

To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction

Area Under Curve (AUC) ( µmol*h/L) of AZD1305

Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula

QTcF interval

Overall Study

Screening for eligibility and no significant changes in the medication for heart failure during the preceding 1 month before enrolment. In addition, patients for whom it was not possible to obtain high quality echocardiographic pictures were excluded from the study. The pre-entry visit was 30 days or less before the first dosing visit.

Arms	Assigned Interventions
Experimental: 1	Drug: AZD1305 iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
Placebo Comparator: 2	Drug: Placebo iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes

Investigate the effect of AZD1305 on patients with left ventricular dysfunction

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=313&filename=CSR-D3190C00013.pdf

CSR-D3190C00013.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator