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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 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Primary Hypercholesterolemia
Mixed Hyperlipidemia
Interventions Drug: niacin (+) laropiprant
Drug: Comparator: aspirin
Drug: Comparator: clopidogrel
Drug: Comparator: laropiprant
Drug: Comparator: placebo
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description Periods 1 and 2 evaluated 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 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
Period Title: Period 1
Started 36 [1]
Completed 35
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
Number randomized
Period Title: Period 2
Started 35 [1]
Completed 34
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
Number who completed Period 1
Period Title: Period 3
Started 20 [1]
Completed 20
Not Completed 0
[1]
of the 36 who started Period 1
Arm/Group Title All Participants
Hide Arm/Group Description Periods 1 and 2 evaluated 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 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 36 participants
55.0
(24 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
16
  44.4%
Male
20
  55.6%
1.Primary Outcome
Title Cutaneous Bleeding Time (BT)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Due to technical reasons, bleeding time was zero for some participants; they were considered to be missing data. Therefore, these observations were excluded from the analysis.
Arm/Group Title Clopidogrel + Aspirin +Laropiprant Clopidogrel + Aspirin
Hide Arm/Group Description:
Participants from Periods 1 and 2
Participants from Periods 1 and 2
Overall Number of Participants Analyzed 34 33
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Seconds
478
(381 to 599)
389
(309 to 490)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clopidogrel + Aspirin +Laropiprant, Clopidogrel + Aspirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric least-squares mean ratio
Estimated Value 1.23
Confidence Interval (2-Sided) 90%
0.96 to 1.56
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Laropiprant + Clopidrogel + Aspirin Clopidogrel + Aspirin Laropiprant + Niacin
Hide Arm/Group Description Participants from Periods 1 and 2 Participants from Periods 1 and 2 Participants from Period 3
All-Cause Mortality
Laropiprant + Clopidrogel + Aspirin Clopidogrel + Aspirin Laropiprant + Niacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Laropiprant + Clopidrogel + Aspirin Clopidogrel + Aspirin Laropiprant + Niacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Laropiprant + Clopidrogel + Aspirin Clopidogrel + Aspirin Laropiprant + Niacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/36 (66.67%)   23/36 (63.89%)   20/20 (100.00%) 
Gastrointestinal disorders       
Diarrhoea  1  0/36 (0.00%)  1/36 (2.78%)  1/20 (5.00%) 
Dry mouth  1  0/36 (0.00%)  1/36 (2.78%)  1/20 (5.00%) 
Flatulence  1  1/36 (2.78%)  0/36 (0.00%)  1/20 (5.00%) 
Nausea  1  0/36 (0.00%)  1/36 (2.78%)  2/20 (10.00%) 
Vomiting  1  0/36 (0.00%)  0/36 (0.00%)  1/20 (5.00%) 
General disorders       
Vessel puncture site haematoma  1  2/36 (5.56%)  1/36 (2.78%)  0/20 (0.00%) 
Vessel puncture site haemorrhage  1  6/36 (16.67%)  3/36 (8.33%)  1/20 (5.00%) 
Infections and infestations       
Gastroenteritis  1  0/36 (0.00%)  0/36 (0.00%)  1/20 (5.00%) 
Upper respiratory tract infection  1  0/36 (0.00%)  0/36 (0.00%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  3/36 (8.33%)  2/36 (5.56%)  0/20 (0.00%) 
Myalgia  1  2/36 (5.56%)  4/36 (11.11%)  0/20 (0.00%) 
Pain in extremity  1  3/36 (8.33%)  1/36 (2.78%)  0/20 (0.00%) 
Nervous system disorders       
Dizziness  1  1/36 (2.78%)  2/36 (5.56%)  2/20 (10.00%) 
Headache  1  5/36 (13.89%)  4/36 (11.11%)  4/20 (20.00%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  3/36 (8.33%)  3/36 (8.33%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders       
Ecchymosis  1  7/36 (19.44%)  4/36 (11.11%)  0/20 (0.00%) 
Vascular disorders       
Flushing  1  2/36 (5.56%)  0/36 (0.00%)  0/20 (0.00%) 
Vasodilation  1  0/36 (0.00%)  0/36 (0.00%)  19/20 (95.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01012219     History of Changes
Other Study ID Numbers: 0524A-114
2009_689
First Submitted: November 10, 2009
First Posted: November 11, 2009
Results First Submitted: March 24, 2011
Results First Posted: April 18, 2011
Last Update Posted: November 2, 2015