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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01012219
First received: November 10, 2009
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Primary Hypercholesterolemia
Mixed Hyperlipidemia
Drug: niacin (+) laropiprant
Drug: Comparator: aspirin
Drug: Comparator: clopidogrel
Drug: Comparator: laropiprant
Drug: Comparator: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Cutaneous Bleeding Time (BT) [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

    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.



Enrollment: 36
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012219

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

Publications:
Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01012219     History of Changes
Other Study ID Numbers: 0524A-114, 2009_689
Study First Received: November 10, 2009
Results First Received: March 24, 2011
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Hyperlipidemia, Familial Combined
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on July 29, 2014