Efficacy and safety of Saroglitazar (LipaglynTM) as Compared to Fenofibrate in Patients With Dyslipidemia (PRESS X)].
- Conditions
- Health Condition 1: null- DyslipidemiaHealth Condition 2: E785- Hyperlipidemia, unspecified
- Registration Number
- CTRI/2013/06/003754
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 1010
1. 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.
1. 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.
6. 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.
14. History of myopathies or evidence of active muscle diseases demonstrated by CPK >=10 times UNL at screening visit
15. History of Pancreatitis in last 3 months
16. 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 fenofibrateTimepoint: 6 weeks, 12 weeks and 24 weeks
- Secondary Outcome Measures
Name Time Method To compare the percentage change in lipid parameters (Time frame: 12 and 24 weeks) <br/ ><br>a. LDL <br/ ><br>b. VLDL <br/ ><br>c. HDL <br/ ><br>d. Total cholesterol <br/ ><br>e. Non HDL cholesterol <br/ ><br>f. Apo A1 <br/ ><br>g. Apo B.Timepoint: 12 weeks and 24 weeks.;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.Timepoint: Week 06