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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
NameTimeMethod
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
NameTimeMethod
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
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