Efficacy and safety of Saroglitazar (LipaglynTM) as Compared to Fenofibrate in Patients With Dyslipidemia (PRESS X)].

Phase 4

Recruiting

• Conditions: Hyperlipidemia, unspecified,

• Registration Number: CTRI/2013/06/003754
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

This is A Multi-centric, Prospective, Randomized, Double- blind, Study to Evaluate the Safety and Efficacy of Saroglitazar (LipaglynTM) 2 and 4 mg as Compared to Fenofibrate 160 mg in Patients With Dyslipidemia 24 Week study.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-03
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 1010

Inclusion Criteria

• Subjects age 18- 65 years, of either sex 2.
• Subjects with hypertriglyceridemia (≥200 mg/dL) at the time of screening and after life style modifications for 6 weeks 3.
• Both diabetic (type 2 diabetes mellitus; should be HbA1c <9%) and non-diabetic 4.
• Body mass index (BMI) > 18.5 kg/m2 5.
• Subject has given informed consent for participation in this trial.

Exclusion Criteria

• Pregnancy and lactation 2.
• History of 5% weight loss in past 6 months 3.
• Subject with diabetes mellitus with HbA1C ≥9% 4.
• Subject with type 1 diabetes 5.
• Subjects on glitazone / glitazar therapy in the past 3 month.
• Subject of nutraceuticals within last 3 months 7.
• Diabetic Ketoacidosis/Hyperosmolar coma 8.
• Subjects having unstable angina, Acute Myocardial Infarction in past 3 months or heart failure of NYHA class (III-IV) 9.
• Uncontrolled hypertension (BP160/100 mmHg) 10.
• History of clinically significant peripheral edema in past 3 months 11.
• History of uncontrolled thyroid disorder (abnormal TSH value) and not controlled by thyroid modulating drugs 12.
• History of active liver disease or gall stones or hepatic dysfunction demonstrated by AST and ALT ≥2.5 times of upper normal limit (UNL) or bilirubin ≥2 times UNL 13.
• Renal dysfunction demonstrated by serum creatinine 1.5 mg/dL or eGFRÂ Â 60Â mL/min/1.73Â m2.
• Any other concurrent serious illness within past 5 years (e.g. tuberculosis, HIV, malignancy) 17.
• History of alcohol and/or drug abuse 18.
• History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients 19.
• Subjects on concomitant medications known to affect the lipid level (Appendix 3) other than statins in past 4 weeks (with TG≥200) 20.
• History of contraceptive, hormone replacement therapy (HRT) or steroids since last 3 months 21.
• Participation in any other clinical trial in the past 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the percentage change in triglyceride (TG) levels in 2 and 4 mg of Saroglitazar as compared to fenofibrate	6 weeks, 12 weeks and 24 weeks

Secondary Outcome Measures

Name	Time	Method
To compare the percentage change in triglyceride (TG) levels in 2 and 4 mg of Saroglitazar as compared to fenofibrate 160 mg at Week 6.	Week 06
To compare the percentage change in lipid parameters (Time frame: 12 and 24 weeks)	a. LDL

Trial Locations

Locations (47)

Apex Hospitals Pvt Ltd., Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Apple Hospital, Surat; 🇮🇳 Surat, GUJARAT, India

Aware Global Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

BAPS Pramukh Swami Hospital, Surat; 🇮🇳 Surat, GUJARAT, India

BGS Hospital, BGS Health & Education City; 🇮🇳 Bangalore, KARNATAKA, India

Bhandari Clinic & Research Centre; 🇮🇳 Jaipur, RAJASTHAN, India

Bhatia Hospital,Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

BSES Municipal General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Chopda Medicare & Research Centre Pvt Ltd; 🇮🇳 Nashik, MAHARASHTRA, India

Department of Endocrinology; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

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Apex Hospitals Pvt Ltd., Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Dr Vipul Khandelwal

Principal investigator

9829193517

drvipulkhandelwal@gmail.com