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€
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,010
- 试验地点
- 47
- 主要终点
- To compare the percentage change in triglyceride (TG) levels in 2 and 4 mg of Saroglitazar as compared to fenofibrate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects age 18- 65 years, of either sex
- •Subjects with hypertriglyceridemia (≥200 mg/dL) at the time of screening and after life style modifications for 6 weeks
- •Both diabetic (type 2 diabetes mellitus; should be HbA1c <9%) and non-diabetic
- •Body mass index (BMI) > 18.5 kg/m2
- •Subject has given informed consent for participation in this trial.
排除标准
- •Pregnancy and lactation
- •History of 5% weight loss in past 6 months
- •Subject with diabetes mellitus with HbA1C ≥9%
- •Subject with type 1 diabetes
- •Subjects on glitazone / glitazar therapy in the past 3 month.
- •Subject of nutraceuticals within last 3 months
- •Diabetic Ketoacidosis/Hyperosmolar coma
- •Subjects having unstable angina, Acute Myocardial Infarction in past 3 months or heart failure of NYHA class (III-IV)
- •Uncontrolled hypertension (BP160/100 mmHg)
- •History of clinically significant peripheral edema in past 3 months
- •History of uncontrolled thyroid disorder (abnormal TSH value) and not controlled by thyroid modulating drugs
- •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
- •Renal dysfunction demonstrated by serum creatinine 1.5 mg/dL or eGFRÂ Â 60Â mL/min/1.73Â m
- •Any other concurrent serious illness within past 5 years (e.g. tuberculosis, HIV, malignancy)
- •History of alcohol and/or drug abuse
- •History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients
- •Subjects on concomitant medications known to affect the lipid level (Appendix 3) other than statins in past 4 weeks (with TG≥200)
- •History of contraceptive, hormone replacement therapy (HRT) or steroids since last 3 months
- •Participation in any other clinical trial in the past 3 months.
结局指标
主要结局
To compare the percentage change in triglyceride (TG) levels in 2 and 4 mg of Saroglitazar as compared to fenofibrate
时间窗: 6 weeks, 12 weeks and 24 weeks
次要结局
- To compare the percentage change in lipid parameters (Time frame: 12 and 24 weeks)(a. LDL)
- 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)
研究者
研究点 (47)
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