Status:
COMPLETED
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™
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
Brief 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 con...
Detailed Description
Three studies comprise this program. Study LOV111859/OM5 (double-blind study) was followed by two open label extensions - LOV111860/OM5X (1st open label extension - 8 weeks) and LOV111821/OM5XX (2nd o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00891293
Start Date
March 1 2006
End Date
May 1 2008
Last Update
January 25 2011
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Spring Valley, California, United States, 91978
2
GSK Investigational Site
Washington D.C., District of Columbia, United States, 20037
3
GSK Investigational Site
Coral Gables, Florida, United States, 33134
4
GSK Investigational Site
Hollywood, Florida, United States, 33023