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

Roche

Status and phase: Completed; Phase 3

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

Treatments: Drug: dalcetrapib; Drug: Placebo; Other: Background care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01516541

2011-001891-21 (EudraCT Number)

NC25608

Details and patient eligibility

About

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.

Enrollment: 2,220 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,220 participants in 2 patient groups, including a placebo group

Dalcetrapib

Experimental group

Description:

Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.

Treatment:

Other: Background care

Drug: dalcetrapib

Placebo

Placebo Comparator group

Description:

Placebo orally daily, on a background of contemporary, guidelines-based medical care.

Treatment:

Drug: Placebo

Other: Background care