Roche dal-ACUTE (WC25501)
Research type
Research Study
Full title
A phase III, double-blind, randomized, placebo-controlled,multi-center study evaluating the efficacy and safety of dalcetrapib on lipids, lipoproteins, apolipoproteins and markers of CV risk in patients hospitalized for an acute coronary syndrome (ACS) when treatment is initiated within 1 week after an ACS (dal-ACUTE).
IRAS ID
68557
Contact name
Kausik Ray
Contact email
Sponsor organisation
F. Hoffman La-Roche
Eudract number
2010-022529-14
Clinicaltrials.gov Identifier
Research summary
This is a research study of an experimental new drug called dalcetrapib. Eligible patients are those who have been admitted to hospital for an acute coronary syndrome (ACS) event (i.e. patient has either had a heart attack or suffered from unstable angina; a condition where the heart doesn't get enough blood flow and oxygen). The purpose of this study is to assess the effects of dalcetrapib on HDL-C levels after 4 weeks of treatment with dalcetrapib when treatment is given within 1 week after an ACS event. During randomisation, eligible patients will be randomly assigned by chance to receive treatment with either 600 mg of dalcetrapib or placebo for 20 weeks. Neither the patient or the study doctor will know which treatment the patient is receiving. Patients will be in the study for approximately 25 weeks (1 week screening, 20 weeks treatment, 4 weeks follow up) and will be required to attend study vists at 4, 8, 12, 20 and 24 weeks after being randomised into the study.
REC name
West of Scotland REC 1
REC reference
11/S0703/1
Date of REC Opinion
7 Apr 2011
REC opinion
Further Information Favourable Opinion