MK0524A Phase IIb Study - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00536237

Purpose

Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone. Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.

Condition	Intervention	Phase
Flushing	Drug: Comparator: niacin / Duration of Treatment: 17 Weeks Drug: MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks Drug: Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients

Resource links provided by NLM:

Drug Information available for: Niacin Niacinamide Laropiprant Niacin hydrochloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

To determine the effect of MK0524A on lipids and blood glucose [ Time Frame: 17 Weeks ]

Secondary Outcome Measures:

To establish the dose for limiting flushing symptoms induced by NIASPAN (R) [ Time Frame: 17 Weeks ]

Estimated Enrollment:	450
Study Start Date:	June 2004
Study Completion Date:	June 2004

Eligibility

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

Criteria

Inclusion Criteria:

Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking > 50mg at screening
Must be willing to complete electronic diary

Exclusion Criteria:

Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT)
You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive
You consume more than 14 alcoholic drinks per week or more than 2 drinks per day

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536237

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Paolini JF, Mitchel YB, Reyes R, Kher U, Lai E, Watson DJ, Norquist JM, Meehan AG, Bays HE, Davidson M, Ballantyne CM. Effects of laropiprant on nicotinic acid-induced flushing in patients with dyslipidemia. Am J Cardiol. 2008 Mar 1;101(5):625-30. Epub 2007 Dec 21.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_618, MK0524A-048
Study First Received:	September 26, 2007
Last Updated:	May 12, 2009
ClinicalTrials.gov Identifier:	NCT00536237 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

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

Signs and Symptoms
Nicotinic Acids
Vitamin B3
Vitamins
Flushing
Micronutrients
Nicotinic Acid
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 September 11, 2009