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: Lipoprotein deficiency,

• Registration Number: CTRI/2014/02/004417
• Lead Sponsor: Intas Pharmaceuticals Ltd

Brief Summary

Around the world, cardiovascular disease (CVD) is the leading cause of deaths for adults. The most important modifiable cardiovascular risk factors are smoking, hypertension, dyslipidemia, obesity and hyperglycemia. These risk factors are often clustered, particularly for patients with type 2 diabetes and/or metabolic syndrome. Among dyslipoproteinemia, mixed or combined hyperlipidemia is a common disorder, occurring in about 30% of myocardial infarction (MI) survivors.

The aim of this study is to evaluate the safety and efficacy of IN-SUPR-002 in comparison with FDC of fenofibrate and rosuvastatin in treatment of patients with mixed dyslipidemia. The study will be carried out in 240 Patients of either sex between 18 and 70 years of age suffering from mixed dyslipidemia enrolled across India.

Both the treatment groups will be compared at the end of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-26
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 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

• Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
• Patients with type 1 diabetes mellitus.
• Patients with thyroid dysfunction.
• Patients with hypersensitivity to rosuvastatin, fenofibric acid or fenofibrate.
• Patients who are chronic alcoholic (> 20 ml of alcohol/day) 6.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% Change in serum triglycerides	At the end of study as compared to baseline

Secondary Outcome Measures

Name	Time	Method
% Change in LDL-C	% Change in HDL-C

Trial Locations

Locations (14)

Chopda Medicare & Research Centre Pvt. Ltd, Magnum Heart Institute; 🇮🇳 Nashik, MAHARASHTRA, India

Health Point multispeciality hospital; 🇮🇳 Kolkata, WEST BENGAL, India

King Georgs Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Madras Medical Mission; 🇮🇳 Chennai, TAMIL NADU, India

Malpani Multispeciality Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Medical College Kolkatta; 🇮🇳 Kolkata, WEST BENGAL, India

Medipoint Hospitals Pvt. Ltd; 🇮🇳 Pune, MAHARASHTRA, India

Muktai Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Nirmal Hospital; 🇮🇳 Jhansi, UTTAR PRADESH, India

SAL Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

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Chopda Medicare & Research Centre Pvt. Ltd, Magnum Heart Institute

🇮🇳Nashik, MAHARASHTRA, India

Dr Manoj Chopda

Principal investigator

rush_manoj@yahoo.com