A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 8/3/2016 |
| Start Date: | April 2008 |
| End Date: | September 2012 |
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.
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.
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).
We found this trial at
412
sites
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