Working… Menu

Lipid Efficacy/Tolerability Study (0524A-020)

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. Identifier: NCT00269204
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : July 27, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Hypercholesterolaemia Mixed Hyperlipidaemia Drug: niacin (+) laropiprant Drug: ER-niacin Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Intervention Details:
  • Drug: niacin (+) laropiprant
    Duration of Treatment - 24 weeks
    Other Name: MK0524A
  • Drug: ER-niacin
    Duration of Treatment - 24 weeks

Primary Outcome Measures :
  1. Reductions of LDL-C concentrations at 24 weeks and better tolerability [ Time Frame: at 24 weeks ]

Secondary Outcome Measures :
  1. Elevations in HDL-C concentrations at 24 weeks [ Time Frame: at 24 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

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 identifier (NCT number): NCT00269204

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Layout table for investigator information
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00269204     History of Changes
Other Study ID Numbers: 0524A-020
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperlipidemia, Familial Combined
Hyperlipoproteinemia Type V
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Nicotinic Acids
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs