MK0524A Clinical Efficacy Study
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks (Drug); MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks (Drug); Comparator : niacin / Duraton of Treatment: 4 Weeks (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
A study to determine lipid changing effects of MK0524A when compared to niacin extended
release (NIASPAN) and placebo.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
Secondary outcome: To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: February 2005
Last updated: September 19, 2007
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