Status:
COMPLETED
Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in h...
Detailed Description
Randomized, double-blind, placebo-controlled, parallel-group study design with eleven clinic visits (one screening visit, three lead-in/baseline visits, and seven treatment visits) After a 4-week diet...
Eligibility Criteria
Inclusion
- Men and women, ages 18-79 years, inclusive
- Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C) level above NCEP ATPIII goals
- Fasting, untreated triglyceride (TG) level in the high to very high range
- Provide written informed consent and authorization for protected health information disclosure
Exclusion
- Pregnancy
- Use of lipid-altering drugs which cannot be stopped
- History of certain cardiovascular conditions or cardiac surgery within prior 6 months
- Body mass index above 40 kg per square meter
- Allergy or sensitivity to omega-3 fatty acids or to statin drugs
- Poorly-controlled conditions including diabetes, hypertension, or thyroid disease
- Certain muscle, liver, kidney, lung, or gastrointestinal conditions
- Certain medications
- Active cancers treated within prior 2 years (except non-melanoma skin cancer)
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00435045
Start Date
February 1 2007
End Date
October 1 2007
Last Update
February 2 2017
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