CTRI/2013/06/003754招募中4 期
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.â?? - ZYH1.12.001.02. PROT
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,010
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
研究者
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