CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,152 enrolled
Drug / intervention
ER niacin (+) laropiprant (ERN/LRPT) +3 moredrug
Likely dose
ER niacin (+) laropiprant (ERN/LRPT) 1gfrom 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/NCT00961636
NCT00961636Phase 3Completed
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A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Long-term Efficacy, Safety and Tolerability of ERN/LRPT in Patients With Dyslipidemia

Merck Sharp & Dohme LLC·interventional·Posted Aug 19, 2009·Updated Feb 16, 2015

In Brief

A Phase 3 clinical trial evaluating ER niacin (+) laropiprant (ERN/LRPT), Extended-release niacin (ERN), and 1 other intervention for Dyslipidemia. Completed, enrolled 1,152 participants.

Detailed Summary

This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms beyond 6 months and will measure the impact of withdrawal of laropiprant in patients following 20 weeks of stable maintenance therapy.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 19, 2009
Enrollment StartOct 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.9 years ago

Interventions

ER niacin (+) laropiprant (ERN/LRPT)drug

One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks

ER niacin (+) laropiprant (ERN/LRPT)drug

One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks.

Extended-release niacin (ERN)drug

Two 1g tablets ERN (2g total) once daily for 12 weeks.

Placebo to ERN/LRPTdrug

One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks