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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

Page last updated: August 23, 2015

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