Back to resultsA Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
Primary Purpose
Primary Hypercholesterolemia, Mixed Hyperlipidemia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
niacin (+) laropiprant
Comparator: aspirin
Comparator: clopidogrel
Comparator: laropiprant
Comparator: placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolemia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Period 1
Period 2
Period 3
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Cutaneous Bleeding Time (BT)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01012219
First Posted
November 10, 2009
Last Updated
October 30, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01012219
Brief Title
A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
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 Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia, Mixed Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Period 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Period 2
Arm Type
Experimental
Arm Description
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).
Arm Title
Period 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
niacin (+) laropiprant
Other Intervention Name(s)
Tredaptive
Intervention Description
open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets
Intervention Type
Drug
Intervention Name(s)
Comparator: aspirin
Intervention Description
81 mg oral tablet once daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Comparator: clopidogrel
Intervention Description
75 mg oral tablet once daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Comparator: laropiprant
Intervention Description
40 mg oral tablet once daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Intervention Description
placebo oral tablet once daily for 7 days
Primary Outcome Measure Information:
Title
Cutaneous Bleeding Time (BT)
Description
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.
Time Frame
Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
24206527
Citation
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.
Results Reference
result
Learn more about this trial
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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