Trials / Completed
CompletedNCT00246701
Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 256 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Not accepted
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 (LOV111818/OM6X) 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Simvastatin | Simvastatin |
| DRUG | Simvastatin + Lovaza | Simvastatin + Lovaza (omega-3-acid ethyl esters) |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2006-06-01
- Completion
- 2006-06-01
- First posted
- 2005-10-31
- Last updated
- 2017-03-28
Source: ClinicalTrials.gov record NCT00246701. Inclusion in this directory is not an endorsement.