A study of IN-SUPR-002 in Comparison With Fixed Dose Combination (FDC) of Fenofibrate and Rosuvastatin in Patients with Mixed Dyslipidemia
Phase 3
Completed
- Conditions
- Health Condition 1: E786- Lipoprotein deficiency
- Registration Number
- CTRI/2014/02/004417
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
Inclusion Criteria
1. Between age of 18 to 70 years
2. Serum triglycerides between 150 mg/dl and 500 mg/dl
3. Serum LDL-C > 100 mg/dl
4. Serum HDL-C < 40 mg/dl for men and < 50 mg/dl for women
5. 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 type 1 diabetes mellitus.
3. Patients with thyroid dysfunction.
4. Patients with hypersensitivity to rosuvastatin, fenofibric acid or
fenofibrate.
5. Patients who are chronic alcoholic ( > 20 ml of alcohol/day)
6. Patients on treatment of spironolactone and cimetidine
7. Patients with renal dysfunction: Serum creatinine > 1.5 mg/dl.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method % Change in serum triglyceridesTimepoint: At the end of study as compared to baseline
- Secondary Outcome Measures
Name Time Method % Change in LDL-C <br/ ><br>% Change in HDL-C <br/ ><br>% Change in total cholesterol <br/ ><br>% Change in VLDL-CTimepoint: At the end of study as compared to baseline