CTRI/2017/09/009644已完成4 期
A Phase IV, Randomized, Open Label, Multicentre Study to Confirm the Safety and Tolerability of Atorsave D (Atorvastain & Cholecalciferol).
Eris Life sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Men or Women, between 18 to 89 years of age (both inclusive).
- •2.Patients who have been prescribed statins OR who have had a recent increase in statin dose (in the last seven days) OR with statin intolerance and complaints of myalgia
- •3.Patient indication and disease condition according to the â??INDICATION & USAGEâ?? as mentioned in the package insert available with Atorsave D
- •4.Women of childbearing potential using an acceptable method of birth control.
- •5.Willing to give written informed consent for participation in the study and to comply with the study procedures
排除标准
- •1.Evidence of active liver disease or SGPT > 2.5 times upper limit of normal (ULN)
- •2.Creatinine phosphokinase Total (CPK-T) elevation more than 3 times the ULN
- •3.Evidence of renal impairment (Serum creatinine levels more than 2.0 mg /dl)
- •4.Pregnancy
- •5.Malignancy
- •6.Contraindication as mentioned in package insert
- •7.Patients with medical conditions that preclude the follow-up as defined in the protocol or otherwise limits participation in this study
研究者
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