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临床试验/NCT06441630
NCT06441630招募中3 期

A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AD-227A and AD-227B Combination Treatment in Patients with Essential Hypertension

Addpharma Inc.1 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2024年7月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
251
试验地点
1
主要终点
Change in MSSBP

研究概览

简要总结

The purpose of this study is to evaluate the efficacy and safety of co-administration of AD-227A and AD-227B in patients with essential hypertension

详细描述

Essential Hypertension

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

  • Signed informed consent
  • Patients with Essential Hypertension
  • Other inclusions applied

排除标准

  • Patient with Secondary Hypertension
  • Other exclusions applied

研究组 & 干预措施

Co-administration of AD-227A and AD-227C

Active Comparator

AD-227A + Placebo of AD-227B + AD-227C

干预措施: AD-227C (Drug)

Co-administration of AD-227A and AD-227C

Active Comparator

AD-227A + Placebo of AD-227B + AD-227C

干预措施: Placebo of AD-227B (Drug)

Co-administration of AD-227A and AD-227B

Experimental

AD-227A + AD-227B + Placebo of AD-227C

干预措施: AD-227A (Drug)

Co-administration of AD-227A and AD-227B

Experimental

AD-227A + AD-227B + Placebo of AD-227C

干预措施: AD-227B (Drug)

Co-administration of AD-227A and AD-227B

Experimental

AD-227A + AD-227B + Placebo of AD-227C

干预措施: Placebo of AD-227C (Drug)

AD-227A

Active Comparator

AD-227A + Placebo of AD-227B + Placebo of AD-227C

干预措施: AD-227A (Drug)

AD-227A

Active Comparator

AD-227A + Placebo of AD-227B + Placebo of AD-227C

干预措施: Placebo of AD-227B (Drug)

AD-227A

Active Comparator

AD-227A + Placebo of AD-227B + Placebo of AD-227C

干预措施: Placebo of AD-227C (Drug)

Co-administration of AD-227A and AD-227C

Active Comparator

AD-227A + Placebo of AD-227B + AD-227C

干预措施: AD-227A (Drug)

结局指标

主要结局

Change in MSSBP

时间窗: Baseline to Week8

Change from Baseline in Mean Sitting Systolic Blood Pressure

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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