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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536510
First Posted: September 27, 2007
Last Update Posted: September 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536510


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00536510     History of Changes
Other Study ID Numbers: 0524A-048
2007_621
First Submitted: September 26, 2007
First Posted: September 27, 2007
Results First Submitted: February 13, 2009
Results First Posted: May 13, 2009
Last Update Posted: September 2, 2015
Last Verified: September 2015

Keywords provided by Merck Sharp & Dohme Corp.:
High Cholesterol
Excess lipids

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs