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临床试验/CTRI/2013/05/003686
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

发起方
Cadila Healthcare

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