Phase II Clinical Study of HRS-9563 in Patients With Mild to Moderate Hypertension
NCT ID: NCT07297797
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
234 participants
INTERVENTIONAL
2025-12-31
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group A: HRS-9563 or Placebo Injection; low dose
HRS-9563 Injection
HRS-9563 Injection
sodium chloride injection
sodium chloride injection
Treatment group B: HRS-9563 or Placebo Injection; Intermediate dose
HRS-9563 Injection
HRS-9563 Injection
sodium chloride injection
sodium chloride injection
Treatment group C: HRS-9563 or Placebo Injection; Medium to high dose
HRS-9563 Injection
HRS-9563 Injection
sodium chloride injection
sodium chloride injection
Treatment group D: HRS-9563 or Placebo Injection; high dose
HRS-9563 Injection
HRS-9563 Injection
sodium chloride injection
sodium chloride injection
Interventions
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HRS-9563 Injection
HRS-9563 Injection
sodium chloride injection
sodium chloride injection
Eligibility Criteria
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Inclusion Criteria
2. Male or female, aged ≥ 18 years and ≤ 75 years;
3. Patients with mild to moderate hypertension;
4. 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 Criteria
2. Orthostatic hypotension;
3. Type 1 diabetes or poorly controlled type 2 diabetes;
4. Occurrence of any cardiovascular or cerebrovascular event within 6 months prior to screening;
5. Presence of uncontrolled severe arrhythmia within 6 months prior to screening;
6. Suspected allergy to the investigational drug or any of its components;
7. Other diseases requiring Renin-Angiotensin-Aldosterone System (RAAS) inhibitor therapy, besides hypertension;
9. Use of any medication affecting blood pressure within 4 weeks prior to screening, or planned use during the study period;
18 Years
75 Years
ALL
No
Sponsors
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Fujian Shengdi Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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HRS-9563-201
Identifier Type: -
Identifier Source: org_study_id