Back to resultsMK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks
MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks
Comparator : niacin / Duraton of Treatment: 4 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Patients must be between the ages of 18 and 70 years
- Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant
Exclusion Criteria:
- Patient has a history of peptic ulcer or gout
- Patient is sensitive to niacin or products containing niacin
- Patient drinks more than 2 alcoholic drinks per day
- Patient has certain heart disease, cancer, or is HIV positive
Sites / Locations
Outcomes
Primary Outcome Measures
To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
Secondary Outcome Measures
To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
Full Information
NCT ID
NCT00533312
First Posted
September 19, 2007
Last Updated
April 5, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00533312
Brief Title
MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)
Official Title
A Multicenter, Randomized, Double-Blinded, Parallel-Design Study to Evaluate the Lipid-Altering Efficacy of 2 Formulations of MK0524A Compared to NIASPAN (TM)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
407 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks
Intervention Type
Drug
Intervention Name(s)
MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator : niacin / Duraton of Treatment: 4 Weeks
Primary Outcome Measure Information:
Title
To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
Time Frame
After 4 weeks
Secondary Outcome Measure Information:
Title
To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
Time Frame
After 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be between the ages of 18 and 70 years
Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant
Exclusion Criteria:
Patient has a history of peptic ulcer or gout
Patient is sensitive to niacin or products containing niacin
Patient drinks more than 2 alcoholic drinks per day
Patient has certain heart disease, cancer, or is HIV positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17392721
Citation
Lai E, De Lepeleire I, Crumley TM, Liu F, Wenning LA, Michiels N, Vets E, O'Neill G, Wagner JA, Gottesdiener K. Suppression of niacin-induced vasodilation with an antagonist to prostaglandin D2 receptor subtype 1. Clin Pharmacol Ther. 2007 Jun;81(6):849-57. doi: 10.1038/sj.clpt.6100180. Epub 2007 Mar 28.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)
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