Status:
COMPLETED
Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia
Lead Sponsor:
Kuhnil Pharmaceutical Co., Ltd.
Conditions:
Diabetes Mellitus, Type 2
Hypertriglycemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in subjects with type 2 Diabetes combined with hyperlipidemia
Eligibility Criteria
Inclusion
- LDL-C \< 100mg/dL, TG \> 150mg/dL, patients on statin treatment for at least 6 weeks prior to randomization.
- Type 2 Diabetes
- HbA1c ≤ 10.0
Exclusion
- Type 1 Diabetes
- Patients with PPAR gamma agonist therapy
- Patients with acute MI, Unstable angina within 6 months
- History of malignant tumor within 2 years
- Women with pregnant, breast-feeding
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT02305355
Start Date
February 1 2009
End Date
February 1 2011
Last Update
December 2 2014
Active Locations (1)
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1
Bucheon St. Mary's Hospital
Bucheon-si, South Korea