12 WEEK TRIAL OF THE EFFICACY AND SAFETY OF IN-SUPR-001 COMPARED TO MICRONIZED FENOFIBRATE IN ADULT PATIENT WITH MIXED DYSLIPIDEMIA

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: IN‐SUPR‐001: 135 mg delayed release tablets. One tablet orally, once daily, on empty stomach in the morning . Control Intervention1: Micronized Fenofibrate: 160 mg micronized tablets One tablet orally, once daily, on empty stomach in the morning . CONDITION: MIXED DYSLIPIDEMIA PRIMARY OUTCOME: % change in triglycerides‐‐‐‐‐‐Timepoint: at the end of study as compared to baseline SECONDARY OUTCOME: % change in HDL‐C‐‐‐‐‐‐Timepoint: at the end of study as compared to baseline INCLUSION CRITERIA: 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
Epistemonikos ID: afbdfa74e967a897637b171f05b7c71ec8842c36
First added on: Aug 22, 2024