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Tracking Information | |||||
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First Received Date † | September 26, 2007 | ||||
Last Updated Date | September 26, 2007 | ||||
Start Date † | June 2004 | ||||
Current Primary Outcome Measures † |
To determine the effect of MK0524A on lipids and blood glucose [ Time Frame: 17 Weeks ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
To establish the dose for limiting flushing symptoms induced by NIASPAN (R) [ Time Frame: 17 Weeks ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | MK0524A Phase IIb Study | ||||
Official Title † | Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients | ||||
Brief Summary | Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone. Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study | ||||
Condition † | Flushing | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
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 † | 450 | ||||
Completion Date | June 2004 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00536237 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Merck | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Merck | ||||
Verification Date | September 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |