A clinical trial to study the effects of two drugs, FDC of Atorvastatin and delayed release fenofibric acid and FDC of Atorvastatin and fenofibrate in patients with mixed dyslipidemia.
Phase 3
- Registration Number
- CTRI/2010/091/001327
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd. Acme Plaza, Andheri Kurla Road,Andheri East. Mumbai-400059.Maharashtra. India.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1.Male or Female patients aged between 18 to 70 years.
2.Patients with Fasting TG ≥ 150mg/dl, HDL-C < 40mg/dl for men and < 50mg/dl for women and LDL-C ≥130mg/dl.
3.Patients willing to give their informed consent.
Exclusion Criteria
1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
2.Patients with cardiovascular disease, type 1 diabetes mellitus.
3.Patients with significantly abnormal laboratory analysis of thyroid function.
4.Patients with severe renal impairment, including those receiving dialysis.
5.Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a)Evaluation of mean percent change in TG <br>b)Evaluation of mean percent change in HDL-C<br>c)Evaluation of mean percent change in LDL-C<br>Timepoint: Baseline (Day 0) and End of treatment (Week 12)
- Secondary Outcome Measures
Name Time Method Evaluation of global impression by investigator and patientTimepoint: Week 12