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

Completed · Phase 3 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT01516541

Run by

Hoffmann-La Roche

People needed

2220

Starts

2012-01-01

Expected to finish

2012-07-01

Last updated by the study team

2016-11-02

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Anaheim, California, United States
• Study site — Fullerton, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Ana, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Torrance, California, United States
• Study site — Torrance, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Lonetree, Colorado, United States
• Study site — Bridgeport, Connecticut, United States
• Study site — Hartford, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Panama City, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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