NCT07297797 Phase II Clinical Study of HRS-9563 in Patients With Mild to Moderate Hypertension
| NCT ID | NCT07297797 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
| Condition | Mild to Moderate Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 234 participants |
| Start Date | 2026-01-14 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 234 participants in total. It began in 2026-01-14 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07297797 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Mild to Moderate Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07297797 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07297797 currently recruiting?
Yes, NCT07297797 is actively recruiting participants. Contact the research team at yuhan.guo.yg21@hengrui.com for enrollment information.
Where is the NCT07297797 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07297797 clinical trial?
NCT07297797 is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. The trial plans to enroll 234 participants.