Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246636
Status:
COMPLETED
Last Update Posted:
2009-12-14
First Post:
2005-10-28
Brief Title:
Evaluation of Efficacy and Safety of Omacor Omega-3-acid Ethyl Esters as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara Fenofibrate Followed by an 8-week Extension
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel-Group Phase IV Study to Assess the Efficacy and Safety of Adjunctive Omacor Therapy in Hypertriglyceridemic Subjects Treated With Antara Followed by an 8-week Extension
Status:
COMPLETED
Status Verified Date:
2009-12
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 OM5LOV111859 was to evaluate efficacy and safety of Omacor omega-3-acid ethyl esters as add-on therapy to Antara fenofibrate and diet for the treatment of patients with very high triglycerides
The purpose of both OM5XLOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza omega-3-acid ethyl esters therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride TG levels
The purpose of both OM5XLOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza omega-3-acid ethyl esters therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride TG levels
Detailed Description:
Three studies comprise this OM5 Program
Study OM5 LOV111859 double-blind study and OM5X LOV111860 1st open-label extension are part of this listing on ClinicalTrialsgov - NCT00246636
Study OM5XX LOV111821 2nd open-label extension is listed as a separate listing on ClinicalTrialsgov - NCT00891293
Study OM5 LOV111859 double-blind study and OM5X LOV111860 1st open-label extension are part of this listing on ClinicalTrialsgov - NCT00246636
Study OM5XX LOV111821 2nd open-label extension is listed as a separate listing on ClinicalTrialsgov - NCT00891293
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 |
|---|---|---|---|
| OM5XLOV111860 1st extension | None | None | None |
| OM5LOV111859 original study | None | None | None |