Clinical Trial: Effect of MK0524A on Flushing Caused by Niacin (0524A-056)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Tolerability and Effect of MK0524A on Niacin-Induced Acute Flushing in Lipid Clinic Patie

Brief Summary: The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: 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. [ Time Frame: Over 1 week ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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). [ Time Frame: Daily ]

Original Secondary Outcome: Same as current

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: September 19, 2007
Date Started: April 2007
Date Completion:
Last Updated: February 16, 2017
Last Verified: February 2017