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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Primary Hypercholesterolemia, Mixed Hyperlipidemia

Intervention / Treatment
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* Drug: niacin (+) laropiprant
* Drug: Comparator: aspirin
* Drug: Comparator: clopidogrel
* Drug: Comparator: laropiprant
* Drug: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1<br>In Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days). | Drug: Comparator: aspirin<br>* 81 mg oral tablet once daily for 7 days<br>Drug: Comparator: clopidogrel<br>* 75 mg oral tablet once daily for 7 days<br>Drug: Comparator: laropiprant<br>* 40 mg oral tablet once daily for 7 days<br>Drug: Comparator: placebo<br>* placebo oral tablet once daily for 7 days<br>|
| Experimental: Period 2<br>In Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days). | Drug: Comparator: aspirin<br>* 81 mg oral tablet once daily for 7 days<br>Drug: Comparator: clopidogrel<br>* 75 mg oral tablet once daily for 7 days<br>Drug: Comparator: laropiprant<br>* 40 mg oral tablet once daily for 7 days<br>Drug: Comparator: placebo<br>* placebo oral tablet once daily for 7 days<br>|
| Experimental: Period 3<br> | Drug: niacin (+) laropiprant<br>* open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets<br>* Other names: Tredaptive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous Bleeding Time (BT) | 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. | Day 8 |