At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
Comparator: ER niacin (+) laropiprant +3 moredrug
Likely dose
Comparator: ER 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.
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 Type 2 Diabetes
In Brief
A Phase 1 clinical trial evaluating Comparator: ER niacin (+) laropiprant, Comparator: ER niacin, and 2 other interventions for Type 2 Diabetes Mellitus. 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 specific metabolite (which is a marker of in vivo platelet reactivity).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
Primary CompletionDec 2007
First PostedFeb 2008
TodayJul 2026
First PostedFeb 20, 2008
Enrollment StartAug 1, 2007
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.4 years ago
Interventions
Comparator: ER niacin (+) laropiprantdrug
ER niacin 2 g/ laropiprant 40 mg daily for 7 days.
Comparator: ER niacindrug
ER niacin 2 g daily for 7 days.
Comparator: laropiprantdrug
laropiprant 40 mg daily for 7 days.
Comparator: placebodrug
matching placebo tablets for each of the interventions once daily for 7 days