A clinical trial to study effectiveness and safety of two medications in patients suffering from dyslipidemia (abnormal lipid levels in blood)
Phase 3
Completed
- Conditions
- Health Condition 1: null- DyslipidemiaHealth Condition 2: E785- Hyperlipidemia, unspecified
- Registration Number
- CTRI/2011/04/001689
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1) The mean percentage change from baseline in other lipid profile at the end of the treatment phase <br/ ><br>2) Evaluation of global efficacy by the investigatorTimepoint: At baseline (Week 0) and at the end of study (Week 12)