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临床试验/CTRI/2017/08/009376
CTRI/2017/08/009376已完成未知

Assessment of modulation of activity of Paraoxonase-1 (PON-1) by statins in patients requiring statin therapy. - PSS

Research Society Seth GSMC and KEM Hospital0 个研究点目标入组 140 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
140

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. Statin naïve patients aged between 18 -75 years of either gender, eligible for statin treatment as per the physicianâ??s diagnosis
  • 2. Patient willing to give written informed consent

排除标准

  • 1. Patients having contraindication to statin like
  • a)Chronic renal failure or serum creatinine > 1.7 times the upper limit
  • b)Unexplained serum CK > 3 times the upper limit of normal Active hepatitis or cholestasis or ALT > 2 times the upper limit of normal.
  • c)Subjects taking one of the following medications and unable to maintain a stable dose at least four weeks prior to the screening visit and for the duration of the study: tamoxifen, raloxifene, estrogen and or progestins, thiazide diuretics, isotretinoin, Ã?-blockers, thyroid hormones, androgens, fiber supplements, protease inhibitors.
  • 2. Patients requiring any other lipid lowering agent other than statins.
  • 3. Patients having co-morbidities like any liver disease.
  • 4. Pregnant and lactating women.
  • 5. Inability to comply with the treatment and study protocol as per the investigatorâ??s judgment.
  • 6. History of alcohol and substance abuse in last four weeks.

研究者

发起方
Research Society Seth GSMC and KEM Hospital

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Paraoxonase-1 activity and effect of statins | 临床试验