Health Condition 1: null- Dyslipidemia Health Condition 2: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: Fenofibric acid 135 mg delayed release capsules: One capsule once daily for entire study duration of 12 weeks
Control Intervention1: Fenofibrate 160 mg tablets: One tablet once daily fo
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with hypertriglyceridemia at the time of enrollment 2. Informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean percentage change from baseline in the serum Triglycerides (TGs) at the end of the treatment phaseTimepoint: At baseline (Week 0) and at the end of study (Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 investigatorTimepoint: At baseline (Week 0) and at the end of study (Week 12) | — |
Countries
India
Contacts
Public ContactDr Amit Kubavat
Outcome results
None listed