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Lipid Efficacy/Tolerability Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00269204
First received: December 21, 2005
Last updated: May 12, 2009
Last verified: May 2009
History of Changes

December 21, 2005
May 12, 2009
December 2005
December 2006   (final data collection date for primary outcome measure)
Reductions of LDL-C concentrations at 24 weeks and better tolerability [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
Reductions of LDL-C concentrations at 24 weeks and better tolerability
Complete list of historical versions of study NCT00269204 on ClinicalTrials.gov Archive Site
Elevations in HDL-C concentrations at 24 weeks [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
Elevations in HDL-C concentrations at 24 weeks
Not Provided
Not Provided
 
Lipid Efficacy/Tolerability Study
A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Lipid-Altering Efficacy, Safety and Tolerability of MK0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

A 28-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9 scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of the 3 treatment groups.
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 Hypercholesterolaemia
  • Mixed Hyperlipidaemia
  • Drug: niacin (+) laropiprant
    Duration of Treatment - 24 weeks
    Other Name: MK0524A
  • Drug: ER-niacin
    Duration of Treatment - 24 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1620
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients 18 to 85 years of age with Primary Hypercholesterolemia or Mixed Hyperlipidemia with LDL-C below 100 mg/dL for high risk patients (patients with Coronary Artery Disease (CHD).
  • Have medical conditions considered to be CHD equivalent).
  • LDL-C below 130 mg/dL for patients with multiple risk factors.
  • LDL-C between 130 and 190 mg/dL for patients with low risk and Triglycerides </= to 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 < 20% compliance, patients with chronic medical conditions, patients with unstable doses of medications.
  • Pregnant or lactating women, or women intending to become pregnant are excluded.
  • Patient with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin).
  • Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, gout (within 1 year).
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00269204
2005_095, MK0524A-020
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
May 2009

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