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ROCHE
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
Study Phase III
Purpose
The study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patient 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 study population will include those who meet the following inclusion/exclusion criteria, some of which are:
Inclusion Criteria
- Men & Women > 45 years of age
- Recently hospitalized for ACS
- Clinically stable
- Receiving evidence-based medical and dietary management of dyslipidemia
- Signed & dated, written informed consent to participate in this study.
Exclusion Criteria
- Uncontrolled diabetes
- Clinically unstable
- Severe anemia
- Uncontrolled hypertension
- Concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates)
To inquire if you are eligible for this study or hear more about it, please contact:
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