A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
Phase 3
Completed
- Conditions
- Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)
- Interventions
- Registration Number
- NCT01516541
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2220
Inclusion Criteria
- Adult patients, >/= 45 years of age
- Established cardiovascular disease A stable coronary disease B cerebrovascular disease C peripheral artery disease
- Without established coronary disease D pharmacologically treated type 2 diabetes mellitus and one or more risk factor(s) for cardiovascular disease E 3 or more risk factors for cardiovascular disease
- Receiving evidence-based medical and dietary management of dyslipidemia
Exclusion Criteria
- Occurrence of myocardial infarction, hospitalization for unstable angina, stroke or revascularization (coronary, carotid or peripheral) within three months prior to randomization
- Uncontrolled hypertension
- Uncontrolled diabetes
- Concomitant treatment with any other drug raising HDL-C
- Previous treatment with compounds targeting cholesteryl ester transfer protein (CETP)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Background care Placebo orally daily, on a background of contemporary, guidelines-based medical care. Placebo Placebo Placebo orally daily, on a background of contemporary, guidelines-based medical care. Dalcetrapib Background care Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care. Dalcetrapib dalcetrapib Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.
- Primary Outcome Measures
Name Time Method Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) approximately 4 years
- Secondary Outcome Measures
Name Time Method All cause mortality approximately 4 years Safety: Incidence of adverse events approximately 4 years Change in blood lipid and lipoprotein levels from baseline to 12 months