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

NCT01012219 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-11-02

Study results available
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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.

Conditions

  • Primary Hypercholesterolemia
  • Mixed Hyperlipidemia

Interventions

DRUG

niacin (+) laropiprant

open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets

DRUG

Comparator: aspirin

81 mg oral tablet once daily for 7 days

DRUG

Comparator: clopidogrel

75 mg oral tablet once daily for 7 days

DRUG

Comparator: laropiprant

40 mg oral tablet once daily for 7 days

DRUG

Comparator: placebo

placebo oral tablet once daily for 7 days

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-03-31
Completion
2010-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01012219 on ClinicalTrials.gov