NCT01725646CompletedPhase 3
A Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of Omacor® in Taiwanese Hypertriglyceridemic Patients
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Excelsior
- Enrollment
- 253
- Locations
- 4
- Primary Endpoint
- Change in Triglycerides from baseline
Study Overview
Brief Summary
- Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients
- Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients
Detailed Description
The primary end point is to evaluate the efficacy and safety of Omacor in Taiwanese hypertriglyceridemia patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient has fasting serum TG ≥ 200 mg/dL but no more than 1000 mg/dL
Exclusion Criteria
- •Patients had a history of pancreatitis or considered to be at risk of developing pancreatitis
- •Patient had history of a severe cardiovascular event or a revascularization procedure within 6 months prior to randomization
Arms & Interventions
Omacor® 4 g
Active Comparator
Subjects in this group will take 4 g of Omacor® everyday.
Intervention: Omacor® (Drug)
Omacor® 2 g
Active Comparator
Subjects in this group will take 2 g of Omacor® and 2 g of placebo everyday.
Intervention: Omacor® (Drug)
Placebo
Placebo Comparator
Subjects in this group will take 4 g of placebo everyday.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in Triglycerides from baseline
Time Frame: baseline and 8 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
Loading locations...
Similar Trials
Completed
Phase 3
Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With HypertriglyceridemiaHypertriglyceridemiaNCT00435045GlaxoSmithKline245
Completed
Phase 3
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial FibrillationFibrillation, AtrialNCT00402363GlaxoSmithKline663
Completed
Phase 3
Omacor and Placebo in Carotid Plaque StabilityCardiovascular DiseaseNCT00294216Pronova BioPharma121
Completed
Phase 4
Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic HemodialysisKidney Failure, ChronicNCT00257283Pronova BioPharma200
Completed
Phase 4
Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week ExtensionHypertriglyceridemiaNCT00246636GlaxoSmithKline167