Clinical Trial: A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Hy
Brief 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.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Cutaneous Bleeding Time (BT) [ Time Frame: Day 8 ]
Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days.
The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable.
Period 3 was not analyzed as bleeding time was not an objective for this part of the study.
Original Primary Outcome: Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days vs. Bleeding Time (BT) on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days [ Time Frame: Day 8 ]
Current Secondary Outcome:
Original Secondary Outcome: Pharmacokinetics of components of Tredaptive in patients with primary hypercholesterolemia or mixed dyslipidemia [ Time Frame: Day 1 ]
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: November 10, 2009
Date Started: November 2009
Date Completion:
Last Updated: October 30, 2015
Last Verified: October 2015
