Trial Outcomes & Findings for A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED) (NCT NCT01012219)

Last Updated: 2015-11-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

36 participants

Primary outcome timeframe

Day 8

Results posted on

2015-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants 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 1 STARTED	36
Period 1 COMPLETED	35
Period 1 NOT COMPLETED	1
Period 2 STARTED	35
Period 2 COMPLETED	34
Period 2 NOT COMPLETED	1
Period 3 STARTED	20
Period 3 COMPLETED	20
Period 3 NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants 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 1 Withdrawal by Subject	1
Period 2 Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=36 Participants 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.
Age, Continuous	55.0 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 8

Population: 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.

Outcome measures

Outcome measures
Measure	Clopidogrel + Aspirin +Laropiprant n=34 Participants Participants from Periods 1 and 2	Clopidogrel + Aspirin n=33 Participants Participants from Periods 1 and 2
Cutaneous Bleeding Time (BT)	478 Seconds Interval 381.0 to 599.0	389 Seconds Interval 309.0 to 490.0

Adverse Events

Laropiprant + Clopidrogel + Aspirin

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Clopidogrel + Aspirin

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Laropiprant + Niacin

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Laropiprant + Clopidrogel + Aspirin n=36 participants at risk Participants from Periods 1 and 2	Clopidogrel + Aspirin n=36 participants at risk Participants from Periods 1 and 2	Laropiprant + Niacin n=20 participants at risk Participants from Period 3
Gastrointestinal disorders Diarrhoea	0.00% 0/36	2.8% 1/36	5.0% 1/20
Gastrointestinal disorders Dry mouth	0.00% 0/36	2.8% 1/36	5.0% 1/20
Gastrointestinal disorders Flatulence	2.8% 1/36	0.00% 0/36	5.0% 1/20
Gastrointestinal disorders Nausea	0.00% 0/36	2.8% 1/36	10.0% 2/20
Gastrointestinal disorders Vomiting	0.00% 0/36	0.00% 0/36	5.0% 1/20
General disorders Vessel puncture site haematoma	5.6% 2/36	2.8% 1/36	0.00% 0/20
General disorders Vessel puncture site haemorrhage	16.7% 6/36	8.3% 3/36	5.0% 1/20
Infections and infestations Gastroenteritis	0.00% 0/36	0.00% 0/36	5.0% 1/20
Infections and infestations Upper respiratory tract infection	0.00% 0/36	0.00% 0/36	5.0% 1/20
Musculoskeletal and connective tissue disorders Back pain	8.3% 3/36	5.6% 2/36	0.00% 0/20
Musculoskeletal and connective tissue disorders Myalgia	5.6% 2/36	11.1% 4/36	0.00% 0/20
Musculoskeletal and connective tissue disorders Pain in extremity	8.3% 3/36	2.8% 1/36	0.00% 0/20
Nervous system disorders Dizziness	2.8% 1/36	5.6% 2/36	10.0% 2/20
Nervous system disorders Headache	13.9% 5/36	11.1% 4/36	20.0% 4/20
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 3/36	8.3% 3/36	0.00% 0/20
Skin and subcutaneous tissue disorders Ecchymosis	19.4% 7/36	11.1% 4/36	0.00% 0/20
Vascular disorders Flushing	5.6% 2/36	0.00% 0/36	0.00% 0/20
Vascular disorders Vasodilation	0.00% 0/36	0.00% 0/36	95.0% 19/20

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER