Merck Carotid Atherosclerosis Trial (MCAT)
Tracking Information
Start Date ICMJE | April 2009 |
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Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 8, 2008) | Comparison of plaque stability biomarkers and cholesterol levels following treatment [ Time Frame: 4 to 12 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00804843 on ClinicalTrials.gov Archive Site |
Descriptive Information
Brief Title ICMJE | Merck Carotid Atherosclerosis Trial |
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Official Title ICMJE | A Randomized Clinical Trial to Evaluate the Effects of High Dose Statin and Niacin Therapy on Excised Plaque Biomarkers in Patients Undergoing Carotid Endarterectomy (CEA) |
Brief Summary | This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Condition ICMJE | Carotid Atherosclerosis |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 100 | ||||
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Estimated Completion Date | July 2010 | ||||
Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 90 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Czech Republic, Italy, Russian Federation, Spain |
Administrative Information
NCT ID ICMJE | NCT00804843 | ||||
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Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. | ||||
Study ID Numbers ICMJE | 2008_598, 111 | ||||
Study Sponsor ICMJE | Merck | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Merck |
Source: http://clinicaltrials.gov/