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

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


Further study details as provided by Merck Sharp & Dohme Corp.:

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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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 Sharp & Dohme Corp.:
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 April 17, 2014