跳至主要内容
临床试验/NCT05970237
NCT05970237招募中不适用

A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension

Boryung Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 9,000 人开始时间: 2023年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
9,000
试验地点
1
主要终点
Target blood pressure control rate

研究概览

简要总结

The purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in patient with type 2 diabetes mellitus and hypertension

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those diagnosed with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab.
  • Those who voluntarily signed a written personal information agreement to participate in this clinical study.
  • Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.

排除标准

  • Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.)
  • Those who have a history of taking dapagliflozin within 4 weeks of baseline (Visit 1)
  • Those who are expected to need insulin prescription during the study period
  • Pregnant women, breast-feeding women

结局指标

主要结局

Target blood pressure control rate

时间窗: 12weeks after administration

Target blood glucose achievement rate

时间窗: 12weeks after administration

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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