Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-02 @ 8:46 AM
Study NCT ID:
NCT00618995
Status:
COMPLETED
Last Update Posted:
2015-09-07
First Post:
2008-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites (0524A-079)(COMPLETED)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed Description:
Subjects will receive 1 of 4 treatments per period and will eventually receive all 4 treatments:
Treatment A: ER niacin 2g/laropiprant 40 mg daily + Placebo to laropiprant for 7 days
Treatment B: ER niacin 2 g daily + Placebo to laropiprant for 7
days
Treatment C: laropiprant 40 mg daily + Placebo to ER niacin/laropiprant for 7 days
Treatment D: placebo daily for 7 days. There will be at least a 7-day interval between dosing on Day 7 of a period and dosing on Day 1 of the subsequent period
Treatment A: ER niacin 2g/laropiprant 40 mg daily + Placebo to laropiprant for 7 days
Treatment B: ER niacin 2 g daily + Placebo to laropiprant for 7
days
Treatment C: laropiprant 40 mg daily + Placebo to ER niacin/laropiprant for 7 days
Treatment D: placebo daily for 7 days. There will be at least a 7-day interval between dosing on Day 7 of a period and dosing on Day 1 of the subsequent period
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2008_508 | None | None | View |