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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)

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ClinicalTrials.gov Identifier: NCT01012219
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : April 18, 2011
Last Update Posted : November 1, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primary Hypercholesterolemia Mixed Hyperlipidemia Drug: niacin (+) laropiprant Drug: Comparator: aspirin Drug: Comparator: clopidogrel Drug: Comparator: laropiprant Drug: Comparator: placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Period 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).
 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
Experimental: Period 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).
 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
Experimental: Period 3 Drug: niacin (+) laropiprant
open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets
Other Name: Tredaptive


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012219


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Publications of Results:

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01012219    
Other Study ID Numbers: 0524A-114
2009_689
First Posted: November 11, 2009    Key Record Dates
Results First Posted: April 18, 2011
Last Update Posted: November 1, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Hyperlipidemia, Familial Combined
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Aspirin
Niacin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists