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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.

Tracking Information
First Submitted Date  ICMJE November 10, 2009
First Posted Date  ICMJE November 11, 2009
Results First Submitted Date  ICMJE March 24, 2011
Results First Posted Date  ICMJE April 18, 2011
Last Update Posted Date November 1, 2015
Study Start Date  ICMJE November 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2009)
Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days vs. Bleeding Time (BT) on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days [ Time Frame: Day 8 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2009)
Pharmacokinetics of components of Tredaptive in patients with primary hypercholesterolemia or mixed dyslipidemia [ Time Frame: Day 1 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Hypercholesterolemia
  • Mixed Hyperlipidemia
Intervention  ICMJE
  • Drug: niacin (+) laropiprant
    open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets
    Other Name: Tredaptive
  • 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
Study Arms  ICMJE
  • 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).
    Interventions:
    • Drug: Comparator: aspirin
    • Drug: Comparator: clopidogrel
    • Drug: Comparator: laropiprant
    • Drug: Comparator: placebo
  • 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).
    Interventions:
    • Drug: Comparator: aspirin
    • Drug: Comparator: clopidogrel
    • Drug: Comparator: laropiprant
    • Drug: Comparator: placebo
  • Experimental: Period 3
    Intervention: Drug: niacin (+) laropiprant
Publications * De Kam PJ, Luo WL, Wenning L, Ratcliffe L, Sisk CM, Royalty J, Radziszewski W, Wagner JA, Lai E. The effects of laropiprant on the antiplatelet activity of co-administered clopidogrel and aspirin. Platelets. 2014;25(7):480-7. doi: 10.3109/09537104.2013.836747. Epub 2013 Nov 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2009)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01012219
Other Study ID Numbers  ICMJE 0524A-114
2009_689
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP