A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 8/3/2016 |
| Start Date: | January 2012 |
| End Date: | July 2012 |
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).
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.
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.
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)
We found this trial at
116
sites
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