Status:
COMPLETED
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
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) \[formerly known as Omacor\] co-administered with simvastatin 40 mg/da...
Detailed Description
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.
Eligibility Criteria
Inclusion
- For LOV111818/OM6X - Subjects were included in the study if they had met all relevant inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8.
- FYI - entry criteria for LOV111818/OM6 (double-blind study)
- 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
Exclusion
- 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
- Use of warfarin (Coumadin)
Key Trial Info
Start Date :
November 15 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2008
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00903409
Start Date
November 15 2005
End Date
June 27 2008
Last Update
October 9 2017
Active Locations (40)
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1
GSK Investigational Site
Mobile, Alabama, United States, 36608
2
GSK Investigational Site
Encinitas, California, United States, 92024
3
GSK Investigational Site
Fresno, California, United States, 93710
4
GSK Investigational Site
Greenbrae, California, United States, 94904