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Lipid Efficacy Study (0524B-022)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00269217
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Primary Hypercholesterolemia Mixed Hyperlipidemia Drug: niacin (+) laropiprant (+) simvastatin Drug: Comparator: niacin (+) laropiprant Drug: Comparator: simvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007



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


Primary Outcome Measures :
  1. Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.

Secondary Outcome Measures :
  1. 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.
  2. 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.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00269217


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

Study Data/Documents: CSR Synopsis Link  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00269217     History of Changes
Other Study ID Numbers: 0524B-022
MK0524B-022
2005_098
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: March 2017

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