Phase 1
Completed N=36
A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
Primary Hypercholesterolemia · Mixed Hyperlipidemia
Source: ClinicalTrials.gov NCT01012219 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcomePrimary: Cutaneous Bleeding Time (BT) — 478; 389 Seconds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cutaneous Bleeding Time (BT) |
478; 389 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01012219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.