Study to Evaluate the Efficacy and Safety of SPH3127 In Patients With Mild-moderate Essential Hypertension
NCT ID: NCT05359068
Last Updated: 2024-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
957 participants
INTERVENTIONAL
2021-06-10
2023-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Stage 1 Arm A
1 SPH3127 tablet，3 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
SPH3127 tablet
1 tablet
Stage 1 Arm B
2 SPH3127 tablets，2 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
SPH3127 tablet
2 tablets
Stage 1 Arm C
4 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
SPH3127 tablet
4 tablets
Stage 1 Arm D
4 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.
Valsartan
1 valsartan capsule
Stage 2 Arm A
2 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
SPH3127 tablet
2 tablets
Stage 2 Arm B
2 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.
Valsartan
1 valsartan capsule
Stage 3
2 SPH3127 tablets, once daily for 40 weeks.
SPH3127 tablet
2 tablets
Interventions
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SPH3127 tablet
1 tablet
SPH3127 tablet
2 tablets
SPH3127 tablet
4 tablets
Valsartan
1 valsartan capsule
SPH3127 tablet
2 tablets
Valsartan
1 valsartan capsule
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with mild-moderate essential hypertension;
3. Participant has understood the study-required procedures, voluntarily signed informed consent.
Exclusion Criteria
2. Suffered by severe heart disease within 6 months;
3. Suffered by severe cerebrovascular disease within 6 months;
4. Suffered by severe or malignant retinopathy;
5. Out of controlled diabetes;
6. History of malignant tumor;
7. History of mental disorder;
8. Subject is planning or in use of other antihypertensive drugs or other drugs may affect blood pressure during the trial;
9. Alcohol or drug abuse;
10. Pregnant, lactating women or subject is planning to pregnant within 6 months after the trial;
11. Assessed by the investigators as unsuitable for participating in the study.
18 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Changsheng Ma
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital, Capitcal Medical University
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Pinggu Hospital
Beijing, Beijing Municipality, China
Affiliated Hospital of Chongqing Three Gorges Medical College
Chongqing, Chongqing Municipality, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Liuzhou people's Hospital
Liuzhou, Guangxi, China
Hainan Third People's Hospital
Sanya, Hainan, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Luoyang Third People's Hospital
Luoyang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji hospital,Tongji Medical college of HUST
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
XiangYa Hospital CentralSouth University
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjin, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The First People's Hospital of Yinchuan
Yinchuan, Ningxia, China
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
West China Hospital,Sichuan University
Chengdu, Sichuan, China
People's Hospital of Tianjin
Tianjin, Tianjin Municipality, China
Tianjin Fourth Central Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial people's Hospital
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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SPH3127-301
Identifier Type: -
Identifier Source: org_study_id
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