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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00246636 |
Recruitment Status :
Completed
First Posted : October 30, 2005
Last Update Posted : December 14, 2009
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | October 28, 2005 | |||
First Posted Date ICMJE | October 30, 2005 | |||
Last Update Posted Date | December 14, 2009 | |||
Study Start Date ICMJE | October 2005 | |||
Actual Primary Completion Date | February 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE |
Change in serum triglycerides | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
Changes in other lipid and biomarker levels | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | 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 | |||
Official Title ICMJE | 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 | |||
Brief Summary | The purpose of OM5/LOV111859 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 OM5X/LOV111860 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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
|||
Condition ICMJE | Hypertriglyceridemia | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * |
|
|||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
167 | |||
Original Enrollment ICMJE |
150 | |||
Actual Study Completion Date ICMJE | March 2007 | |||
Actual Primary Completion Date | February 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | For OM5/LOV111858 - Inclusion Criteria:
Exclusion Criteria:
For OM5X/LOV111859 - Subjects were included in the study if they met the following criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years to 79 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00246636 | |||
Other Study ID Numbers ICMJE | OM5 program (Reliant) OM5/LOV111859 (original study) OM5X/LOV111860 (1st extension) |
|||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Study Director, GSK | |||
Study Sponsor ICMJE | GlaxoSmithKline | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | GlaxoSmithKline | |||
Verification Date | December 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |