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

A RANDOMIZED, OPEN LABEL, MULTICENTRE, COMPARATIVE CLINICAL TRIAL OF IN-SUPR-001 IN COMPARISON TO MICRONISED FENOFIBRATE IN PATIENTS OF MIXED DYSLIPIDEMIA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/006086

Enrollment

200

Registered

2010-12-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- MIXED DYSLIPIDEMIA

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
% change in triglyceridesTimepoint: at the end of study as compared to baseline	—

Secondary

Measure	Time frame
% change in HDL-CTimepoint: at the end of study as compared to baseline	—

Countries

India

Contacts

Public ContactDr Hanmant Barkate

Intas Pharma

drbarkate@intaspharma.com26576655

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026