CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
niacin (+) laropiprant +4 moredrug
Likely dose
niacin (+) laropiprant 1000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01012219
NCT01012219Phase 1Completed

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

Merck Sharp & Dohme LLC·interventional·Posted Nov 11, 2009·Updated Nov 2, 2015

In Brief

A Phase 1 clinical trial evaluating niacin (+) laropiprant, Comparator: aspirin, and 3 other interventions for Primary Hypercholesterolemia and Mixed Hyperlipidemia. Completed, enrolled 36 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2009
Enrollment StartNov 1, 2009
Primary CompletionMar 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.6 years ago

Interventions

niacin (+) laropiprantdrug

open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets

Comparator: aspirindrug

81 mg oral tablet once daily for 7 days

Comparator: clopidogreldrug

75 mg oral tablet once daily for 7 days

Comparator: laropiprantdrug

40 mg oral tablet once daily for 7 days

Comparator: placebodrug

placebo oral tablet once daily for 7 days