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临床试验/NCT06683768
NCT06683768已完成不适用

Safety of Hypertension Medication Therapy in Patient With Naive Hypertension: a Real-world Study in Japan

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 40,563 人开始时间: 2023年2月28日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40,563
试验地点
1
主要终点
Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This was a non-interventional, secondary use of data, retrospective, cohort study. The data extracted in this study was used as secondary use of collected patient information in the database, Japan Medical Data Survey (JAMDAS), owned by M3 Inc. (Tokyo, Japan). JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of medical institutions, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities etc.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE

时间窗: Week 8 and Week 24

Number of Patients With AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE

时间窗: Week 8 and Week 24

Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE

时间窗: Week 8 and Week 24

Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.

次要结局

  • Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Blood Pressure (BP) Category(Week 24)
  • Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category(Week 24)
  • Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category(Week 24)
  • Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category(Week 24)
  • Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category(Week 24)
  • Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category(Week 24)
  • Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Body Mass Index (BMI) Category(Week 24)
  • Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category(Week 24)
  • Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category(Week 24)
  • Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Estimated Glomerular Filtration Rate (eGFR) Category(Week 24)
  • Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category(Week 24)
  • Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category(Week 24)
  • Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level(Week 24)
  • Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level(Week 24)
  • Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level(Week 24)
  • Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level(Week 24)
  • Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level(Week 24)
  • Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level(Week 24)
  • Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria(Week 24)
  • Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria(Week 24)
  • Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria(Week 24)
  • Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication(Week 24)
  • Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication(Week 24)
  • Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication(Week 24)
  • Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12(Weeks 4, 8, and 12)
  • Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BP Category(Weeks 4, 8, and 12)
  • Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Age Group Category(Weeks 4, 8, and 12)
  • Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BMI Category(Weeks 4, 8, and 12)
  • Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by eGFR Category(Weeks 4, 8, and 12)
  • Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Potassium Level(Weeks 4, 8, and 12)
  • Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Creatinine Level(Weeks 4, 8, and 12)
  • Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Proteinuria(Weeks 4, 8, and 12)
  • Number of Patients who Achieved the BP Goal at Last Visit Categorized by Subgroup(Up to 13 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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