NCT01012219

A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)

A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination and to Evaluate Single Dose Pharmacokinetics of MK0524A in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 will be open-label and will evaluate single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.

Conditions

• Primary Hypercholesterolemia
• Mixed Hyperlipidemia

Interventions

Type	Name	Description
DRUG	niacin (+) laropiprant	open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets
DRUG	Comparator: aspirin	81 mg oral tablet once daily for 7 days
DRUG	Comparator: clopidogrel	75 mg oral tablet once daily for 7 days
DRUG	Comparator: laropiprant	40 mg oral tablet once daily for 7 days
DRUG	Comparator: placebo	placebo oral tablet once daily for 7 days

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2009-11-11
• Last updated: 2015-11-02
• Results posted: 2011-04-18