CTRI/2013/05/003686尚未招募4 期
A Post Marketing Surveillance study to assess the efficacy and safety of PIVASTA (Pitavastatin) Tablets in patients of Type 2 Diabetes mellitus and dyslipidemia
Cadila Healthcare0 个研究点目标入组 500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
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. Patients of either sex, 18-75 years of age..
- •2. Patients who are diagnosed of Type 2 Diabetes
- •3. Patients with any one of the following: serum Low density Lipoprotein (LDL) cholesterol > 100 mg/dl, Or serum high density lipoprotein (HDL) cholesterol < 40 mg/dl (for male), HDL < 50 mg/dl (for female), Or serum triglycerides (TG) > 150 mg/dl
排除标准
- •Patients who is:
- •1. Known to have hypersensitivity to pitavastatin
- •2. Having active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
- •3. Pregnant woman or may become pregnant in next 3 months
- •4. Nursing mother
- •5. on cyclosporine
- •6. Has change/titration in anti-diabetic medications in last one month
- •7. On statin or other lipid lowering therapy during last 3 months
- •8. creatinine clearance < 30 ml/min/1.73 m2
- •9. not willing to give written consent for enrollment in the study.
研究者
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