A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome
Overview
- Phase
- Phase 3
- Intervention
- Dalcetrapib (RO4607381)
- Conditions
- Coronary Heart Disease
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 15871
- Primary Endpoint
- Incidence of Cardiovascular Mortality and Morbidity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adult patients, \>=45 years of age;
- •recently hospitalized for ACS;
- •clinically stable;
- •receiving evidence-based medical and dietary management of dyslipidemia.
Exclusion Criteria
- •uncontrolled diabetes;
- •clinically unstable;
- •severe anemia;
- •uncontrolled hypertension;
- •concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).
Arms & Interventions
Dalcetrapib (RO4607381)
Intervention: Dalcetrapib (RO4607381)
Dalcetrapib (RO4607381)
Intervention: Evidence-based medical care for Acute Coronary Syndrome
Placebo
Intervention: Evidence-based medical care for Acute Coronary Syndrome
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of Cardiovascular Mortality and Morbidity
Time Frame: From date of randomization to first event up to 48 months
Number of cardiovascular events per patient per year
Secondary Outcomes
- Composite Endpoint:All Cause Mortality(Throughout Study, up to 53 Months)
- Change From Baseline for HDL Cholesterol(At 53 Months)
- Adverse Events, Lab Parameters, Vital Signs, ECG(Throughout Study, up to 53 Months)