RecruitingPhase 2

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

China234 participantsStarted 2026-01-14

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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;
✕. Any blood biochemical indicator during screening or baseline did not meet the standards in the exclusion criteria;

What they're measuring

Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 6

Timeframe: at 6 months after initiation of administration

Trial details

NCT IDNCT07297797

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Yuhan Guo

+0518-81220121 yuhan.guo.yg21@hengrui.com

View on ClinicalTrials.gov More Mild to Moderate Hypertension trials