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

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.

Timeline

Start

2009-11

Primary completion

2010-03

Completion

2010-04

Outcome

Missed primary endpoint

registry Geometric least-squares mean ratio 1.23 (90% CI 0.96 to 1.56) NCT01012219 ↗

paper with corresponding upper bounds of the 90% CI marginally exceeding the prespecified upper comparability bound of 1.50 in both studies. PMID 24206527 ↗

Publications

• Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Niacin	Small molecule	1000 mg	Oral
Subject	laropiprant	Small molecule	20 mg	Oral
Subject	laropiprant	Small molecule	40 mg	Oral
Background	Aspirin	Small molecule	81 mg	Oral
Background	Clopidogrel	Small molecule	75 mg	Oral

Indications