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| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 13, 2005 |
| Last Updated Date | March 14, 2011 |
| Start Date ICMJE | October 2005 |
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
To measure the effect of treatment with ezetimibe/simvastatin compared with simvastatin monotherapy on death due to any cardiovascular events, non-fatal coronary events (such as heart attack), and non-fatal strokes [ Time Frame: Trial will continue until a minimum of 5,250 subjects have a primary endpoint event and each subject is followed for a minimum of 2.5 years. Thus, the anticipated completion dates below may be adjusted on the basis of actual event occurrance. ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE |
To measure the effect of treatment with ezetimibe/simvastatin compared with simvastatin monotherapy on death due to any cardiovascular events, non-fatal coronary events (such as heart attack), and non-fatal strokes [ Time Frame: Trial will continue until a minimum of 5,250 subjects have an primary endpoint event and each subject is followed for a minimum of 2.5 years ] [ Designated as safety issue: No ] |
| Change History | Complete list of historical versions of study NCT00202878 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |
| Brief Title ICMJE | IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (Study P04103AM3) |
| Official Title ICMJE | A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT) |
| Brief Summary | This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. If LDL-C response is inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, as appropriate, may be increased to 80 mg. Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of CV death, major coronary events, and stroke. |
| Detailed Description | |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 3 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Enrollment ICMJE | 18141 |
| Estimated Completion Date | June 2013 |
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT Number ICMJE | NCT00202878 |
| Other Study ID Numbers ICMJE | P04103 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| Study Sponsor ICMJE | Schering-Plough |
| Collaborators ICMJE | Merck |
| Investigators ICMJE | |
| Information Provided By | Schering-Plough |
| Verification Date | March 2011 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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