CTRI/2011/04/001689CompletedPhase 3
A randomized, open label, phase III, comparative, multicentric study to assess the efficacy and safety of Fenofibric acid delayed release capsules versus Fenofibrate tablets in patients with dyslipidemia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Cadila Healthcare Ltd
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Patients with hypertriglyceridemia at the time of enrollment
- •2.Informed consent
Exclusion Criteria
- •1.Pregnancy, lactation and women of childbearing potential not using appropriate contraceptive measures.
- •2.Patients already receiving drugs belonging to the fibric acid derivatives.
- •3.Patients with hepatic or renal dysfunction.
- •4.Patients with history of myopathy or evidence of active muscle disease.
- •5.Patients with any other serious concurrent illness or malignancy.
- •6.Patients with continuing history of alcohol and / or drug abuse.
- •7.Patients with persistent gall bladder diseases.
- •8.Patients with known hypersensitivity to fenofibric acid.
- •9.Participation in another clinical trial in the past 3 months
Investigators
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