Effect of MK0524A on Flushing Caused by Niacin (0524A-056)
Phase 3
Completed
- Conditions
- Flushing
- Registration Number
- NCT00533611
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
Inclusion Criteria
- Patient is male or female between 18 and 70 years of age
- Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study
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Exclusion Criteria
- Patient has a history of hypersensitivity to niacin or niacin-containing products
- Patient is currently experiencing menopausal hot flashes
- Patient consumes more than 2 alcoholic beverages per day
- Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
- Patient engages in vigorous exercise or an aggressive diet regimen
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme. Over 1 week
- Secondary Outcome Measures
Name Time Method MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater). Daily