Phase II Clinical Study of HRS-9563 in Patients With Mild to Moderate Hypertension

Fujian Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Mild to Moderate Hypertension

Treatments: Drug: sodium chloride injection; Drug: HRS-9563 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07297797

HRS-9563-201

Details and patient eligibility

About

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.

Enrollment: 234 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subject voluntarily signs the informed consent form.
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

1. Secondary hypertension;
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;
8. Any blood biochemical indicator during screening or baseline did not meet the standards in the exclusion criteria;
9. Use of any medication affecting blood pressure within 4 weeks prior to screening, or planned use during the study period;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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234 participants in 4 patient groups

Treatment group A: HRS-9563 or Placebo Injection; low dose

Experimental group

Treatment:

Drug: HRS-9563 Injection

Drug: sodium chloride injection

Treatment group B: HRS-9563 or Placebo Injection; Intermediate dose

Experimental group

Treatment:

Drug: HRS-9563 Injection

Drug: sodium chloride injection

Treatment group C: HRS-9563 or Placebo Injection; Medium to high dose

Experimental group

Treatment:

Drug: HRS-9563 Injection

Drug: sodium chloride injection

Treatment group D: HRS-9563 or Placebo Injection; high dose

Experimental group

Treatment:

Drug: HRS-9563 Injection

Drug: sodium chloride injection