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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Flushing

Intervention: MK0524A, /Duration of Treatment : 4 Weeks (Drug); Comparator : niacin /Duration of Treatment : 1 Weeks (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


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

Clinical Details

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 Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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.

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).


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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 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

Locations and Contacts

Additional Information

Related publications:

Kush D, Hu DY, Ye P, Kim HS, Chen E, Sirah W, McCrary Sisk C, Paolini JF, Maccubbin D. Flushing profile of extended-release niacin/laropiprant at initiation of therapy in Asian lipid clinic patients. Cardiology. 2009;114(3):192-8. doi: 10.1159/000228585. Epub 2009 Jul 15.

Starting date: April 2007
Last updated: August 5, 2014

Page last updated: August 23, 2015

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