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临床试验/CTRI/2014/02/004417
CTRI/2014/02/004417已完成3 期

A Randomized, Open Label, Multicentre, Comparative Clinical Trial of IN-SUPR-002 in Comparison with Fixed Dose Combination (FDC) of Fenofibrate and Rosuvastatin in Patients with Mixed Dyslipidemia - NA

Intas Pharmaceuticals Ltd0 个研究点目标入组 240 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
已完成
入组人数
240
研究概览入排标准研究者记录与标识符相似试验

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. Between age of 18 to 70 years
  • •2. Serum triglycerides between 150 mg/dl and 500 mg/dl
  • •3. Serum LDL-C > 100 mg/dl
  • •4. Serum HDL-C < 40 mg/dl for men and < 50 mg/dl for women
  • •5. Willing to give their informed consent.

排除标准

  • •1. Pregnant, lactating women or women of childbearing age who are not
  • •using an acceptable method of birth control.
  • •2. Patients with type 1 diabetes mellitus.
  • •3. Patients with thyroid dysfunction.
  • •4. Patients with hypersensitivity to rosuvastatin, fenofibric acid or
  • •fenofibrate.
  • •5. Patients who are chronic alcoholic ( > 20 ml of alcohol/day)
  • •6. Patients on treatment of spironolactone and cimetidine
  • •7. Patients with renal dysfunction: Serum creatinine > 1.5 mg/dl.

研究者

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