RecruitingPhase 2NCT07297797
Phase II Clinical Study of HRS-9563 in Patients With Mild to Moderate Hypertension
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-9563 in Patients With Mild to Moderate Hypertension
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Enrollment
234 participants
Start Date
Jan 14, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
This study aims to evaluate the efficacy and safety of HRS-9563 in patients with mild to moderate hypertension, and to explore its appropriate dosage.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- The subject voluntarily signs the informed consent form.
- Male or female, aged ≥ 18 years and ≤ 75 years;
- Patients with mild to moderate hypertension;
- At the Screening and Baseline periods, the mean sitting office systolic blood pressure is \> 130 mmHg, and the 24-hour mean systolic blood pressure assessed by ABPM at Screening is ≥ 130 mmHg and \< 160 mmHg.
Exclusion Criteria8
- Secondary hypertension;
- Orthostatic hypotension;
- Type 1 diabetes or poorly controlled type 2 diabetes;
- Occurrence of any cardiovascular or cerebrovascular event within 6 months prior to screening;
- Presence of uncontrolled severe arrhythmia within 6 months prior to screening;
- Suspected allergy to the investigational drug or any of its components;
- Other diseases requiring Renin-Angiotensin-Aldosterone System (RAAS) inhibitor therapy, besides hypertension;
- Use of any medication affecting blood pressure within 4 weeks prior to screening, or planned use during the study period;
Interventions
DRUGHRS-9563 Injection
HRS-9563 Injection
DRUGsodium chloride injection
sodium chloride injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07297797