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Effect of MK0524A on Cholesterol Levels (0524A-048)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00536510
First received: September 26, 2007
Last updated: November 3, 2010
Last verified: November 2010
History of Changes
  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 3

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

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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 ]
    Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100


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 ]
    Percent change from baseline in High Density Lipoprotein Cholesterol (HDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100


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
Experimental: 1
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

Other Name: MK0524A
Placebo Comparator: 2
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

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 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: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00536510     History of Changes
Other Study ID Numbers: MK0524A-048, 2007_621
Study First Received: September 26, 2007
Results First Received: February 13, 2009
Last Updated: November 3, 2010
Health Authority: China: Ministry of Health

Keywords provided by Merck:
High Cholesterol
Excess lipids

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013