Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD) Clinical Trial
Official title:
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).
| Verified date | November 2016 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 2220 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Australia, Canada, China, Czech Republic, Denmark, France, Hungary, Mexico, Netherlands, Poland, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) | approximately 4 years | No | |
| Secondary | All cause mortality | approximately 4 years | No | |
| Secondary | Safety: Incidence of adverse events | approximately 4 years | No | |
| Secondary | Change in blood lipid and lipoprotein levels | from baseline to 12 months | No |