A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).

Conditions
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Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)

Intervention / Treatment
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* Other: Background care
* Drug: Placebo
* Drug: dalcetrapib


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dalcetrapib<br>Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care. | Other: Background care<br>* Guidelines-based medical care<br>Drug: dalcetrapib<br>* 600 mg orally daily<br>|
| Placebo Comparator: Placebo<br>Placebo orally daily, on a background of contemporary, guidelines-based medical care. | Other: Background care<br>* Guidelines-based medical care<br>Drug: Placebo<br>* Matching dalcetrapib placebo orally daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) |  | approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |