Effect of MK0524A on Cholesterol Levels - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00536510

Purpose

The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.

Condition	Intervention	Phase
Hypercholesterolemia Hyperlipidemia	Drug: laropiprant/niacin (MK0524A) Drug: Comparator: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Lipid-Altering Efficacy and Safety and Tolerability of MK0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Niacin Niacinamide Laropiprant Niacin hydrochloride

Further study details as provided by Merck:

Primary Outcome Measures:

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	646
Study Start Date:	April 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental laropiprant/niacin (MK0524A)	Drug: laropiprant/niacin (MK0524A) Treatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization
2: Placebo Comparator placebo	Drug: Comparator: placebo Treatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization.

Eligibility

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 not being able to take niacin or niacin-containing products
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: NCT00536510

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_621, MK0524A-048
Study First Received:	September 26, 2007
Results First Received:	February 13, 2009
Last Updated:	May 19, 2009
ClinicalTrials.gov Identifier:	NCT00536510 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Merck:

High Cholesterol
Excess lipids

Study placed in the following topic categories:

Hyperlipidemias
Metabolic Diseases
Niacinamide
Nicotinamide
Nicotinic Acids
Combined Hyperlipidemia, Familial
Vitamin B3

Hyperlipidemia, Familial Combined
Nicotinic Acid
Hypercholesterolemia
Metabolic Disorder
Niacin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Metabolic Diseases
Hyperlipidemias
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009