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Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)

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ClinicalTrials.gov Identifier: NCT00378833
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There will be 6 scheduled clinic visits and 2 treatment groups.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Hyperlipidemia Drug: niacin (+) laropiprant Drug: niacin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Worldwide, Multicenter, Double-Blind, Parallel Study to Evaluate the Tolerability of MK0524A Versus Niacin Extended-Release
Study Start Date : July 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: niacin (+) laropiprant
    Duration of Treatment: 18 Weeks
    Other Name: MK0524A
  • Drug: niacin
    Duration of Treatment: 18 Weeks


Primary Outcome Measures :
  1. Global Flushing Severity Score (GFSS) over 16 weeks

Secondary Outcome Measures :
  1. Safety/tolerability


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides < 500 mg/dL

Exclusion Criteria:

  • Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) >/= 130 mg/dL and/or not on a statin
  • Patients with diabetes and LDL-C >/= 130 mg/dL. Patients with >/= 2 heart disease risk factors and LDL-C >/= 160 mg/dL.
  • Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.

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): NCT00378833


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

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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00378833     History of Changes
Other Study ID Numbers: 0524A-054
2006_529
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Primary Hypercholesterolemia or Mixed Hyperlipidemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs