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™
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
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 open label extension - 24 months).
Studies LOV111859/OM5 and LOV111860/OM5X are outlined in NCT00246636.
Age
18–79
Sex
ALL
Healthy volunteers
Not accepted
You may not be if
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.
Clareo Health | 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™
