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
- Locations
- 5
- Primary Endpoint
- The mean percentage change from baseline in the serum Triglycerides (TGs) at the end of the treatment phase
Study Overview
Brief Summary
Open label, randomized, phase III, multicentricstudy.
Comparison of efficacy and safety ofFenofibric acid delayed release capsules verses Fenofibrate tablets in theIndian dyslipidemic patients.
Primary outcome of the study was themean percentage change from baseline in the serum Triglycerides (TGs) at theend of the treatment phase.
Fenofibricacid delayed release capsules have a comparable therapeutic efficacy asFenofibrate tablets in Indian patients suffering from dyslipidemia.
On the tolerability front Fenofibricacid delayed release capsules were as well tolerated as Fenofibrate tablets.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
The mean percentage change from baseline in the serum Triglycerides (TGs) at the end of the treatment phase
Time Frame: At baseline (Week 0) and at the end of study (Week 12)
Secondary Outcomes
- 1) The mean percentage change from baseline in other lipid profile at the end of the treatment phase(2) Evaluation of global efficacy by the investigator)