Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246701
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2005-10-28
Brief Title:
Evaluation of Efficacy and Safety of Combined Omacor Omega-3-acid Ethyl Esters and Simvastatin Therapy in Hypertriglyceridemic Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects
Status:
COMPLETED
Status Verified Date:
2017-03
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:
COMBOS
Brief Summary:
The purpose of OM6 is to evaluate efficacy and safety of Lovaza omega-3-acid ethyl esters formerly known as Omacor combined with simvastatin for lowering non-high-density lipoprotein cholesterol non-HDL-C in subjects with persistent high triglycerides despite statin therapy
Additionally a two-year extension trial LOV111818OM6X is posted on NCT00903409
Additionally a two-year extension trial LOV111818OM6X is posted on NCT00903409
Detailed Description:
Two studies comprise this OM6 Program Study OM6 LOV111858 double-blind study and is not required to post results based on FDAAA Study OM6X LOV111818 open-label extension is posted on NCT00903409
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LOV111818 | OTHER | GSK | None |