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Lipid Efficacy Study

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00269217
First received: December 21, 2005
Last updated: March 6, 2008
Last verified: March 2008
  Purpose

This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6 scheduled clinic visits, and 7 treatment arms.


Condition Intervention Phase
Primary Hypercholesterolemia
Mixed Hyperlipidemia
Drug: niacin (+) laropiprant (+) simvastatin
Drug: Comparator: niacin (+) laropiprant
Drug: Comparator: simvastatin
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, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Coadministered MK0524B Tablets 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:
  • Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.

Secondary Outcome Measures:
  • Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than simvastatin.
  • Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK0524A.

Enrollment: 1400
Study Start Date: January 2006
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: niacin (+) laropiprant (+) simvastatin
    Duration of Treatment 12 Weeks
    Other Name: MK0524B
    Drug: Comparator: niacin (+) laropiprant
    Duration of Treatment 12 Weeks
    Other Name: MK0524A
    Drug: Comparator: simvastatin
    Duration of Treatment 12 Weeks
    Other Name: MK0733
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia
  • LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides </= 350 mg/dL.

Exclusion Criteria:

  • A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
  • Patients with <80% compliance
  • Patients with certain medical conditions
  • Patients taking certain concomitant medications and/or with unstable doses of medications
  • Or those with a history of CHD/CHD equivalent or diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269217

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

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00269217     History of Changes
Other Study ID Numbers: 2005_098, MK0524B-022
Study First Received: December 21, 2005
Last Updated: March 6, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemia, Familial Combined
Hyperlipidemias
Hyperlipoproteinemia Type V
Dyslipidemias
Genetic Diseases, Inborn
Hyperlipoproteinemias
Hypertriglyceridemia
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors
Niacin
Niacinamide
Nicotinic Acids
Simvastatin
Anticholesteremic Agents
Antimetabolites
Cardiovascular Agents
Enzyme Inhibitors
Growth Substances
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014