Last updated: 11/03/2018 12:16:01
A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (formerly known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated with Antara™
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (formerly known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated with Antara™
Trial description: This was a 24-month, open-label extension study that followed an 8-week double-blind study (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid ethyl esters) and Antara (fenofibrate) would result in a greater reduction in serum triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone. This second extension of 24 months was to assess the continued efficacy of adjunctive Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] therapy in hypertriglyceridemic subjects treated with Antara (fenofibrate) in lowering serum triglyceride (TG) levels.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Percent Change in serum triglycerides from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension).
Timeframe: Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Secondary outcomes:
Percent Change in total cholesterol from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study).
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Percent Change in VLDL-C from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study)
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Percent Change in LDL-C from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study)
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Percent Change in HDL-C from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study)
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Percent Change in ratio of Total-C:HDL-C from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL ext. study)
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Percent Change in apo A-1 from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Percent Change in apo B from LOV111859/OM5 (double-blind [DB[ study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study)
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Percent Change in non-HDL-C from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study)
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Interventions:
Drug: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
Enrollment:
93
Observational study model:
Not applicable
Primary completion date:
2008-07-05
Time perspective:
Not applicable
Clinical publications:
Roth EM, Bays HE, Forker AD, Maki KC, Carter R, Doyle RT, Stein EA. Prescription Omega-3 Fatty Acid as an Adjunct to Fenofibrate Therapy in Hypertriglyceridemic Subjects. J Cardiovasc Pharmacol. 2009 Sep 54:196-203.
TENTATIVE: Roth EM, Bays HE, Forker AD, Maki KC, Carter R, Doyle RT, Stein EA. Prescription Omega-3 Fatty Acid as an Adjunct to Fenofibrate Therapy in Hypertrigylceridemic Subjects. [J Cardiovasc Pharmacol]. 2009;54(3):196-203.
Medical condition
Hypertriglyceridemia
Product
GI104000, GSK2295313, omega-3-acid ethyl esters
Collaborators
Not applicable
Study date(s)
March 2006 to May 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 79 years
Accepts healthy volunteers
No
- Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation.
- Eligibility for entry into this study was based on the inclusion/exclusion criteria described of the double-blind LOV111859/OM5 protocol.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation. Eligibility for entry into this study was based on the inclusion/exclusion criteria described of the double-blind LOV111859/OM5 protocol. Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation. The main eligibility criteria for LOV111859/OM5 were,
- 18 to79 years of age (inclusive) at screening
- fasting serum TG levels ≥500 mg/dL and <1300 mg/dL
- BMI ≥ 25 kg/m2 and ≤43 kg/m2. Subjects enrolled directly from the end of LOV111860/OM5X into LOV111821/OM5XX.
Trial location(s)
Location
GSK Investigational Site
Statesville, North Carolina, United States, 28677
Status
Study Complete
Location
GSK Investigational Site
Wentzville, Minnesota, United States, 62285
Status
Study Complete
Location
GSK Investigational Site
Spring Valley, California, United States, 91978
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20037
Status
Study Complete
Location
GSK Investigational Site
Longwood, Florida, United States, 32779
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64111
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40213
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45212
Status
Study Complete
Location
GSK Investigational Site
Duhwoody, Georgia, United States, 30338
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Winchester, Virginia, United States, 22601
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33023
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21209
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27106
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60610
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32259
Status
Study Complete
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Pinellas Park, Florida, United States, 33781
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23502
Status
Study Complete
Location
GSK Investigational Site
Cumberland, Rhode Island, United States, 02864
Status
Study Complete
Location
GSK Investigational Site
Scarborough, Maine, United States, 04074
Status
Study Complete
Location
GSK Investigational Site
Bloomington, Indiana, United States, 47403
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-07-05
Actual study completion date
2008-07-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website