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Tracking Information | |||||
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First Received Date † | August 18, 2008 | ||||
Last Updated Date | September 23, 2008 | ||||
Start Date † | April 2005 | ||||
Current Primary Outcome Measures † |
The annual progression of the slope of the maximum average GIM and the arterial rigidity. [ Time Frame: 1 Year ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00738296 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Vytorin on Carotid Intima-Media Thickness and Overall Rigidity | ||||
Official Title † | Vytorin on Carotid Intima-Media Thickness and Overall Rigidity | ||||
Brief Summary | Comparison of the effect on the progression of the carotid intima-media interphase thickness (GIM), arterial rigidity according to the measurement of the pulse wave speed and direct measurement of the carotid and aortic rigidities and an inflammation marker (PCR) in patients with established cardiovascular disease (myocardial infarct, atherosclerotic coronary disease), diabetes mellitus type 2 or equivalent risk of coronary disease and a low density lipoprotein level > 100 mg/dL, treated with simvastatin, pravastatin or the combination of simvastatin-ezetimibe during a period of at least one year. |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Cardiovascular Diseases | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 90 | ||||
Completion Date | December 2005 | ||||
Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
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Gender | Both | ||||
Ages | 30 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00738296 | ||||
Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. | ||||
Secondary IDs †† | MK0653A-164 | ||||
Study Sponsor † | Hospital Universitario 12 de Octubre | ||||
Collaborators †† | Merck | ||||
Investigators † |
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Information Provided By | Hospital Universitario 12 de Octubre | ||||
Verification Date | August 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |