Clareo Health | Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Two studies comprise this OM6 Program. Study LOV111858/OM6 (double-blind study) which is outlined in NCT00246701 and Study LOV111818/OM6X (open-label extension) outlined in this posting.
Age
18–79
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men and women ages 18-79 years, inclusive
Current therapy with a statin drug
Triglyceride levels between 200 and 499 mg/dL
Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests
Provide written informed consent and authorization for protected health information disclosure
You may not be if
FYI - entry criteria for LOV111818/OM6 (double-blind study)
Sensitivity to statin drugs or omega-3 fatty acids
Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia
Unexplained muscle pain or weakness
History of pancreatitis
Recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or cancer (except non-melanoma skin cancer)
Poorly controlled diabetes, or receiving insulin therapy
Pregnant or lactating females. Women of childbearing potential who are not using a medically approved method of contraception.
Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs
