RECRUITINGPhase 2INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. The subject voluntarily signs the willing to sign a consent form 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.
Who Should NOT Join This Trial:
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;
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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;
Treatments Being Tested
DRUG
HRS-9563 Injection
HRS-9563 Injection
DRUG
sodium chloride injection
sodium chloride injection
Locations (1)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China