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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
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.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 15871 |
| Start date | 2008-04 |
| Completion | 2012-09 |
Conditions
- Coronary Heart Disease
Interventions
- Dalcetrapib (RO4607381)
- Evidence-based medical care for Acute Coronary Syndrome
- Placebo
Primary outcomes
- Incidence of Cardiovascular Mortality and Morbidity — From date of randomization to first event up to 48 months
Number of cardiovascular events per patient per year
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Grenada, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Puerto Rico, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom