12 WEEK TRIAL OF THE EFFICACY AND SAFETY OF IN-SUPR-001 COMPARED TO MICRONIZED FENOFIBRATE IN ADULT PATIENT WITH MIXED DYSLIPIDEMIA
- Conditions
- Health Condition 1: null- MIXED DYSLIPIDEMIA
- Registration Number
- CTRI/2010/091/006086
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Mixed Dyslipidemic patients of either gender
1.Age of 18 to 70 (excluding both) years
2.serum triglyceride levels between 150 mg/dl and 500 mg/dl
3.who are prescribed statin in stable dose since minimum 8 weeks.
In case of female patients with child bearing potential: surgically sterile or using a medically accepted means of contraception with negative serum pregnancy test
Patients with
1.Pregnany, lactating women or women of childbearing age who are not using an acceptable method of birth control.
2.Patients with serum Low Density Lipoprotein Cholesterol (LDL-C) >160 mg/dl
3.Patients with type 1 diabetes mellitus.
4.Patients with thyroid dysfunction.
5.Patients with active liver disease, including those with primary biliary cirrhosis or liver dysfunction: Liver enzymes more than 2.5 times upper normal limit.
6.Patients with preexisting gallbladder disease.
7.Patients with hypersensitivity to fenofibric acid or fenofibrate.
8.Patients taking oral coumarin anticoagulant.
9.Patients who are chronic alcoholic ( > 20 ml of alcohol/day)
10.Patient on treatment with cyclosporine, niacin (nicotinic acid), erythromycin, azole antifungals.
11.Patients taking antacid, Colestipol.
12.Patients on treatment of endogenous steroid hormones, ketoconazole, spironolactone, and cimetidine
13.Patients with renal dysfunction: Serum creatinine more than 1.5 times upper normal limit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method % change in triglyceridesTimepoint: at the end of study as compared to baseline
- Secondary Outcome Measures
Name Time Method % change in HDL-CTimepoint: at the end of study as compared to baseline