日本临床试验

概述

收录日本注册临床试验信息，涵盖基本信息、试验设计详情、招募信息、研究者信息、适应症、临床研发阶段、临床试验状态以及临床试验结果等内容，目前收录信息7万余条。

数据结构及样例

{
   "试验登记号":"UMIN000054277",
  "查看全文":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061771",
  "登记日期":"2024-04-28", 
  "其他试验登记号":["1637/E/MDX","C12-17"],
  "试验标题":"TEFFICACY AND SAFETY OF TESOFENSINE FOR THE TREATMENT OF OBESITY IN ADULTS. A PHASE 3 RANDOMIZED CONTROLLED STUDY",
  "正式的科学名称":"Clinical study to evaluate the efficacy and safety of Tesofensine on body weight loss and body composition of Mexican patients with obesity. Double-blind, randomized, placebo-controlled, multicenter clinical trial.",
  "试验简称":"MEX-TESObesity;TESObesity",
  "国家/地区":"North America（北美）",
  "开始日期":"2017-08-08",
  "结束日期":"",
  "末次随访日期":"2018-01-29",
  "最近更新日期":"2024-04-27",
  "招募状态":"Completed（完成招募）",
  "注册机构":"日本",
  "药品名称":"",
  "适应症":"Obesity（肥胖）",
  "治疗领域":"",
  "试验阶段":"Phase 3 Clinical（Ⅲ期）",
  "试验类型":"Interventional（干预性研究）",
  "试验目标":"Treatment（治疗性）",
  "干预类型":"Drug（药品）",
  "干预分组方式":"随机化",
  "盲法":"双盲",
  "对照类型":"安慰剂对照",
  "设计类型":"平行设计",
  "组数":"3",
  "试验方案":"序号 ：干预组别 : 干预措施,1 : Interventions/Control_1 : Intervention - Tesofensine 0.25 mg,2 : Interventions/Control_2 : Intervention - Tesofensine 0.50 mg,3 : Interventions/Control_3 : Placebo",
  "终点类型":"Other（其他）",
  "主要的疗效判定指标":"1. Mean change in absolute and percentage body weight after 24 weeks of treatment 2. Proportion of drug-related adverse events after 24 weeks of treatment",
  "次要的疗效判定指标":"1. Proportion of subjects who reached a body weight percentage equal or higher than 5 and 10 percentage after 12 and 24 weeks of treatment. 2. Absolute difference between baseline and week 24 in body mass index ",  
  "目标入组人数":"372",
  "实际入组人数":"372",
  "年龄范围":"18 years - 65 years",
  "性别":"Male and Female",
  "入选标准":"1. Men and women with ages between 18 to 65 years,2. A body mass index (BMI) greater than or equal to 30 and lower than 50,3. Agreed to participate in the study and provided their written informed consent.4. Women of childbearing age who declared using a contraceptive method",
  "排除标准":"11. Pregnant or lactating women 2. Hypersensitivity to tesofensine 3. Treatment with special diets (vegan or ketogenic)4. Prior pharmacological or surgical treatment against obesity,5. Presence of chronic metabolic diseases or another diseases as:a) Uncontrolled type 2 diabetes (without regular treatment with metformin or lifestyle modifications)b) Uncontrolled systemic arterial hypertension c) Psychiatric illnesses d) Thyroid disease e) Cardiovascular diseasesf) Gastrointestinal malabsorptive disease g) Cancer h) Ophthalmologic disease i) Electrocardiographic abnormalities j) History of hypotension",
  "首例受试者入组日期":"",
  "申办单位":"Instituto Politecnico Nacional",
  "合作单位":"",
  "联系人信息":"序号 : 联系人类型 : 姓名 : 联系方式 1 : 公众联系人 : Reyes-Garcia Gerardo Juan : 525557296300;jgreyesg@ipn.mx2 : 科学联系人 : Reyes-Garcia Gerardo Juan : 525557296300;jgreyesg@ipn.mx",
  "是否有临床试验结果":"是",
  "临床试验结果":"1 : -- : https://siipris03.cofepris.gob.mx/Resoluciones/Consultas/ConWebRegEnsayosClinicosDetalle.asp?idsolic",
  }