Overview

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™

Status:
Completed
Trial end date:
2008-05-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Fenofibrate
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.