Conditions: Primary Hypercholesterolemia Mixed Hyperlipidemia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 36
Healthy volunteers: no

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:

Arms:
arm 1: 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). arm 2: 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). arm 3: None

Interventions: intervention 1: niacin (+) laropiprant intervention 2: Comparator: aspirin intervention 3: Comparator: clopidogrel intervention 4: Comparator: laropiprant intervention 5: Comparator: placebo
Intervention descriptions: intervention 1: open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets intervention 2: 81 mg oral tablet once daily for 7 days intervention 3: 75 mg oral tablet once daily for 7 days intervention 4: 40 mg oral tablet once daily for 7 days intervention 5: placebo oral tablet once daily for 7 days

Protocol document: