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

Phase 1

Completed

• Conditions: Primary Hypercholesterolemia; Mixed Hyperlipidemia
• Interventions: Drug: niacin (+) laropiprant

• Registration Number: NCT01012219
• Lead Sponsor: Merck Sharp & Dohme LLC

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 Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Results First Submitted: 2011-03-24
• Results First Submitted QC: 2011-03-24
• Results First Posted: 2011-04-18
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Participant has primary hypercholesterolemia or mixed dyslipidemia (high cholesterol)
• Participant is a non-smoker

Exclusion Criteria

• Participant has a history of chronic seizures
• Participant has a history of cancer
• Participant has a history of stomach or intestinal ulcers or any history of GI bleeding
• Participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 3	niacin (+) laropiprant	-

Primary Outcome Measures

Name	Time	Method
Cutaneous Bleeding Time (BT)	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.