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
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