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

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.

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Key information

Conditions

Primary Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Mixed Hyperlipidemia Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

niacin (+) laropiprant

Drug

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

Other names: Tredaptive

Comparator: aspirin

Drug

81 mg oral tablet once daily for 7 days

Comparator: clopidogrel

Drug

75 mg oral tablet once daily for 7 days

Comparator: laropiprant

Drug

40 mg oral tablet once daily for 7 days

Comparator: placebo

Drug

placebo oral tablet once daily for 7 days

Primary outcomes

Cutaneous Bleeding Time (BT)

Time frame: Day 8

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Nov 11, 2009
Registry last updated: Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed