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临床试验/CTRI/2008/091/000265
CTRI/2008/091/000265已完成3 期

A comparative clinical trial of R-Sibutramine versus racemate Sibutramine in the management of obesity

Emcure Pharmaceuticals Ltd., Pune0 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
3 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
Interventional

入排标准

入选标准

  • Subjects with body mass index greater than 27 kg/m2
  • Subjects of either sex and aged between 18-65 years

排除标准

  • Known hypersensitivity to Sibutramine
  • Concomitant use of MAO inhibitors, centrally acting appetite suppressants, other centrally acting drugs, drugs that affect hemostasis or platelet function
  • Drug, tobacco or alcohol abuse
  • Psychiatric disorders
  • Endocrine disease other than type II diabetes
  • History of arrhythmias, congestive heart failure, coronary artery disease, stroke, seizures
  • Severe hypertension
  • Pulmonary hypertension
  • Benign prostatic hyperplasia with urinary retention
  • Phaeochromocytoma
  • Hyperthyroidism
  • Untreated hypothyroidism
  • Severe renal or hepatic impairment
  • Narrow angle glaucoma
  • Predisposal to bleeding events
  • Lactating or pregnant women or women of childbearing potential not practicing an effective mode of contraception
  • Organic causes of obesity e.g. Cushing?s syndrome, hypogonadism, congenital disorders, lipodystrophy, lipoatrophy etc.
  • History of major eating disorders
  • Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study

研究者

发起方
Emcure Pharmaceuticals Ltd., Pune

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