Status:
COMPLETED
A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)
Eligibility:
All Genders
45+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
2220 Patients enrolled
Trial Details
Trial ID
NCT01516541
Start Date
January 1 2012
End Date
July 1 2012
Last Update
November 2 2016
Active Locations (241)
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1
Birmingham, Alabama, United States, 35294-0007
2
Huntsville, Alabama, United States, 35801
3
Anaheim, California, United States, 92801
4
Fullerton, California, United States, 92835