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Lipid Efficacy Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00269217
First received: December 21, 2005
Last updated: March 6, 2008
Last verified: March 2008
History of Changes

December 21, 2005
March 6, 2008
January 2006
January 2007   (final data collection date for primary outcome measure)
Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
MK-0524B will be more efficacious in reducing LDL-C concentrations compared to MK-0524A.
Complete list of historical versions of study NCT00269217 on ClinicalTrials.gov Archive Site
  • 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.
MK-0524B 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. MK-0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK-0524A.
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Not Provided
 
Lipid Efficacy Study
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Primary Hypercholesterolemia
  • Mixed Hyperlipidemia
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1400
Not Provided
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00269217
2005_098, MK0524B-022
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP