A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
Status and phase
Completed
Phase 1
Conditions
Mixed Hyperlipidemia
Primary Hypercholesterolemia
Treatments
Drug: Comparator: laropiprant
Drug: Comparator: clopidogrel
Drug: Comparator: aspirin
Drug: Comparator: placebo
Drug: niacin (+) laropiprant
Details and patient eligibility
About
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.
Enrollment
36 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
36 participants in 3 patient groups
Period 1
Experimental group
Description:
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).
Treatment:
Drug: Comparator: clopidogrel
Drug: Comparator: placebo
Drug: Comparator: aspirin
Drug: Comparator: laropiprant
Period 2
Experimental group
Description:
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).
Treatment:
Drug: Comparator: clopidogrel
Drug: Comparator: placebo
Drug: Comparator: aspirin
Drug: Comparator: laropiprant
Period 3
Experimental group
Treatment:
Drug: niacin (+) laropiprant
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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