Study to Evaluate the Efficacy and Safety of SPH3127 In Patients With Mild-moderate Essential Hypertension
- Registration Number
- NCT05359068
- Lead Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Brief Summary
The primary aim of the study is to assess the antihypertensive efficacy of SPH3127 in patients with mild to moderate essential hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 957
- Male or female of age ≥18 years;
- Diagnosed with mild-moderate essential hypertension;
- Participant has understood the study-required procedures, voluntarily signed informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage 1 Arm A SPH3127 tablet 1 SPH3127 tablet，3 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks. Stage 1 Arm B SPH3127 tablet 2 SPH3127 tablets，2 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks. Stage 1 Arm C SPH3127 tablet 4 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks. Stage 2 Arm A SPH3127 tablet 2 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks. Stage 3 SPH3127 tablet 2 SPH3127 tablets, once daily for 40 weeks. Stage 1 Arm D Valsartan 4 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks. Stage 2 Arm B Valsartan 2 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12 Measure at week 12 of treatment.
- Secondary Outcome Measures
Name Time Method Changes from baseline in mean sitting diastolic blood pressure (msSBP) at week 2, 4, 6, 8, 10 and 12. Measured at week 2, 4, 6, 8, 10, and 12 of treatment. Changes from baseline in mean sitting diastolic blood pressure (msDBP) at week 2, 4, 6, 8 and 10 Measured at week 2, 4, 6, 8 and 10 of treatment. Plasma concentration of SPH3127. 12 weeks. Total effective rate at week 2, 4, 6, 8, 10 and 12 Measured at week 2, 4, 6, 8, 10, and 12 of treatment. Rate of reaching target blood pressure at week 2, 4, 6, 8, 10 and 12 Measured at week 2, 4, 6, 8, 10, and 12 of treatment. Number of subjects with adverse event. 12 weeks. Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events 12 weeks.
Related Research Topics
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Trial Locations
- Locations (40)
Beijing Pinggu Hospital
🇨🇳Beijing, Beijing, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
Liuzhou people's Hospital
🇨🇳Liuzhou, Guangxi, China
Luoyang Third People's Hospital
🇨🇳Luoyang, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
XiangYa Hospital CentralSouth University
🇨🇳Changsha, Hunan, China
Tongji hospital,Tongji Medical college of HUST
🇨🇳Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
The First People's Hospital of Yinchuan
🇨🇳Yinchuan, Ningxia, China
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Affiliated Hospital of Chongqing Three Gorges Medical College
🇨🇳Chongqing, Chongqing, China
Guangdong Second Provincial General Hospital
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
Hainan Third People's Hospital
🇨🇳Sanya, Hainan, China
The Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The Third Xiangya Hospital of Central South 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 First Affiliated Hospital with Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjin, Jiangsu, China
Suzhou Municipal Hospital
🇨🇳Suzhou, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The People's Hospital of Liaoning Province
🇨🇳Shenyang, Liaoning, China
Yuncheng Central Hospital
🇨🇳Yuncheng, Shanxi, China
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
🇨🇳Shanghai, Shanghai, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
People's Hospital of Tianjin
🇨🇳Tianjin, Tianjin, China
West China Hospital,Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Fourth Central Hospital
🇨🇳Tianjin, Tianjin, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
Zhejiang Provincial people's Hospital
🇨🇳Hangzhou, Zhejiang, China