A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
Tracking Information
Start Date ICMJE | April 2008 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: April 10, 2008) | Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) [ Time Frame: Event driven ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00658515 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: April 10, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome |
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Official Title ICMJE | 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 |
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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Coronary Heart Disease |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Publications * |
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Recruitment Information
Estimated Enrollment ICMJE | 15600 | ||||
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Estimated Completion Date | April 2013 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 45 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Korea, Republic of, Netherlands, New Zealand, Poland, Puerto Rico, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00658515 | ||||
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Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
Study ID Numbers ICMJE | NC20971, 2007-005103-18 | ||||
Study Sponsor ICMJE | Hoffmann-La Roche | ||||
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Investigators ICMJE |
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Information Provided By | Hoffmann-La Roche |
Source: http://clinicaltrials.gov/