Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of SPH3127 In Patients With Mild-moderate Essential Hypertension
Lead Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Conditions:
Essential Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary aim of the study is to assess the antihypertensive efficacy of SPH3127 in patients with mild to moderate essential hypertension.
Eligibility Criteria
Inclusion
- Male or female of age ≥18 years;
- Diagnosed with mild-moderate essential hypertension;
- Participant has understood the study-required procedures, voluntarily signed informed consent.
Exclusion
- Diagnosed with secondary hypertension, suspected grade 3 hypertension, acute hypertension, or at risk when current antihypertensive therapy discontinued;
- Suffered by severe heart disease within 6 months;
- Suffered by severe cerebrovascular disease within 6 months;
- Suffered by severe or malignant retinopathy;
- Out of controlled diabetes;
- History of malignant tumor;
- History of mental disorder;
- Subject is planning or in use of other antihypertensive drugs or other drugs may affect blood pressure during the trial;
- Alcohol or drug abuse;
- Pregnant, lactating women or subject is planning to pregnant within 6 months after the trial;
- Assessed by the investigators as unsuitable for participating in the study.
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2023
Estimated Enrollment :
957 Patients enrolled
Trial Details
Trial ID
NCT05359068
Start Date
June 10 2021
End Date
December 26 2023
Last Update
May 7 2024
Active Locations (40)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100005
2
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100069
3
Beijing Pinggu Hospital
Beijing, Beijing Municipality, China, 101299
4
Affiliated Hospital of Chongqing Three Gorges Medical College
Chongqing, Chongqing Municipality, China, 404037