CTRI/2019/02/017410已完成未知
EFFICACY AND SAFETY OF SAROGLITAZAR AND FENOFIBRATE IN THE TREATMENT OF DIABETIC DYSLIPIDEMIA: AN OPEN LABEL COMPARATIVE STUDY. - Saroglitazar vs Fenofibrate
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- •Diagnosed patients of diabetic dyslipidemia with (fasting TG > 200 to 400 mg/dL)
- •2. Patients in the age group of 18 to 65 years,
- •3.Patients with history of type 2 diabetes mellitus (glycosylated hemoglobin [HbA1c]
- •>7% to 9%),
- •4.Patients being treated with either a sulphonylurea, metformin for diabetes, or both treatments for at least 3 months.
- •5.Patients being treated with Atorvastatin 10mg tablet for at least 4 weeks.
排除标准
- •1.Patients on insulin, glitazone or glitazar, or medications with a lipid-lowering agent in
- •past 2 weeks.
- •2.Patients who had a history of cardiac abnormalities (myocardial infarction, coronary
- •artery bypass graft, percutaneous transluminal coronary angioplasty,unstable angina or
- •heart failure, hypertension ( >150/100 mmHg).
- •3. Patients with thyroid dysfunction.
- •4. Patients having hepatic dysfunction (aspartate aminotransferase/alanine aminotransferase ââ?°Â¥2.5 times of upper normal limit [UNL] or bilirubin > 2 times of UNL).
- •5. Patients with renal dysfunction (serum creatinine >1.2 mg/dL).
- •6. Patients with Comorbid serious illness such as tuberculosis, HIV, Malignancy.
- •7. Patients on Alcohol or drug abuse.
- •8. Patients allergic to the study medications
- •9. Pregnant female patients and nursing mothers were also be excluded.
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