ACT-246475 in Coronary Artery Disease
Research type
Research Study
Full title
A multi-center, double-blind, randomized, placebo-controlled study to assess the pharmacodynamics, pharmacokinetics, tolerability, and safety of a single subcutaneous injection of ACT-246475 in adults with stable coronary artery disease
IRAS ID
235066
Contact name
Robert Storey
Contact email
Sponsor organisation
Idorsia Pharmaceuticals Ltd.
Eudract number
2017-003332-36
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
The purpose of the study is to test if the study drug is safe and effective at treating patients with coronary artery disease (disease of the blood vessels supplying the heart muscle).
About 324 people will participate in the study. Eligible patients will be randomly assigned to receive treatment with either study drug or placebo. Each patient will receive a subcutaneous injection of either 8mg or 16 mg of the study drug, or matching placebo, either in the thigh or abdomen.
The study comprises three consecutive periods:
Screening period: 1 to 21 days. To determine if the patient is eligible to participate in the study.
Treatment period: 2 days. Study drug administration and safety assessments.
Follow up period: 28 to 35 days. Begins after the treatment period and ends with a safety follow-up telephone call.A number of assessments and procedures will be performed to determine if the study drug is effective and safe. These include blood sample assessments, physical examinations, blood pressure measurements and electrocardiograms (ECGs).
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
17/YH/0388
Date of REC Opinion
20 Dec 2017
REC opinion
Further Information Favourable Opinion