CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Comparator: niacin + laropiprant +3 moredrug
Likely dose
Comparator: niacin + laropiprant 2 gfrom 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/NCT00769132
NCT00769132Phase 1Completed

A Randomized, Double-Blind, Placebo-Controlled, 4-Period, Crossover Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With Hypercholesterolemia

Merck Sharp & Dohme LLC·interventional·Posted Oct 8, 2008·Updated Nov 21, 2019

In Brief

A Phase 1 clinical trial evaluating Comparator: niacin + laropiprant, Comparator: niacin, and 2 other interventions for Hypercholesterolemia. Completed, enrolled 26 participants.

Detailed Summary

The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a metabolite of thromboxane A2 (TxA2), as a marker of in vivo platelet reactivity.

Study Details

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

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 8, 2008
Enrollment StartAug 3, 2007
Primary CompletionOct 13, 2007
Study CompletionNov 6, 2007
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.7 years ago

Interventions

Comparator: niacin + laropiprantdrug

ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days

Comparator: niacindrug

ER niacin 2 g tablet once daily for 7 days

Comparator: laropiprantdrug

laropiprant 40 mg once daily for 7 days

Comparator: placebodrug

matching placebo tablets for each of the interventions once daily for 7 days