MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)

Hypercholesterolemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533312
• Other study ID #: 0524A-026
• Secondary ID: 2007_619
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2007
• Last updated: April 5, 2017
• Start date: April 2005
• Est. completion date: January 2007

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: January 2007
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks

• MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks

• Comparator : niacin / Duraton of Treatment: 4 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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):849-5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.		After 4 weeks
Secondary	To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.		After 4 weeks