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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00658515 |
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 500+ individuals.
Condition | Intervention | Phase |
---|---|---|
Coronary Heart Disease |
Drug: RO4607381 Drug: Placebo Drug: Evidence-based medical care for Acute Coronary Syndrome |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 15600 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | February 2012 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: RO4607381
600mg po daily
Drug: Evidence-based medical care for Acute Coronary Syndrome
As prescribed
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2: Placebo Comparator |
Drug: Placebo
po daily
Drug: Evidence-based medical care for Acute Coronary Syndrome
As prescribed
|
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: PDO_NC20971 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | NC20971, 2007-005103-18 |
Study First Received: | March 28, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00658515 |
Health Authority: | United States: Food and Drug Administration |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Acute Coronary Syndrome |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |