Effect of MK0524A on Flushing Caused by Niacin - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00533611

Purpose

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

Condition	Intervention	Phase
Flushing	Drug: MK0524A, /Duration of Treatment : 4 Weeks Drug: Comparator : niacin /Duration of Treatment : 1 Weeks	Phase III

Drug Information available for: Niacin Niacinamide Laropiprant Niacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	300
Study Start Date:	April 2007
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533611

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Study ID Numbers:	2007_604
Study First Received:	September 19, 2007
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00533611 History of Changes
Health Authority:	China: Ministry of Health

Study placed in the following topic categories:

Antimetabolites
Vasodilator Agents
Niacinamide
Vitamin B Complex
Antilipemic Agents
Trace Elements
Cardiovascular Agents

Signs and Symptoms
Nicotinic Acids
Vitamins
Flushing
Micronutrients
Niacin

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Antilipemic Agents
Physiological Effects of Drugs
Cardiovascular Agents

Pharmacologic Actions
Signs and Symptoms
Therapeutic Uses
Vitamins
Flushing
Micronutrients
Niacin

ClinicalTrials.gov processed this record on May 07, 2009