Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 11:36 PM
Study NCT ID:
NCT01414166
Status:
TERMINATED
Last Update Posted:
2015-05-13
First Post:
2011-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
A 16-Week, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Extended Release Niacin/Laropiprant in South and Southeast Asians Not on a Lipid Modulating Agent, With Decreased High-Density Lipoprotein Cholesterol and Low- Density Lipoprotein Cholesterol at or Below NCEP ATP III Goal
Status:
TERMINATED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination tablets in a primary prevention population currently not taking or eligible for lipid-modifying therapy (LMT); the population will comprise participants with low to moderate risk for coronary heart disease (CHD), low high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) at or below goal level, and normal or mildly elevated triglyceride (TG) levels.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CTRI/2012/08/002873 | REGISTRY | CTRI | View |