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The primary aim of the study is to assess the antihypertensive efficacy of SPH3127 in patients with mild to moderate essential hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 Arm A | Experimental | 1 SPH3127 tablet,3 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks. |
|
| Stage 1 Arm B | Experimental | 2 SPH3127 tablets,2 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks. |
|
| Stage 1 Arm C | Experimental | 4 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks. |
|
| Stage 1 Arm D | Experimental | 4 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks. |
|
| Stage 2 Arm A | Experimental | 2 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks. |
|
| Stage 2 Arm B | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH3127 tablet | Drug | 1 tablet |
| |
| SPH3127 tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12 | Measure at week 12 of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Changsheng Ma | Beijing Anzhen Hospital, Capitcal Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 100005 | China | ||
| Beijing Anzhen Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42165988 | Derived | Lv Q, Ma C, Wang F, Li L, Xiong G, Li Z, Qu Y, Pang W, Xiao W, Ruan H, Wei L, Liu G, Zhang J, Liu Q, Lin L, Long M, Li H, Yuan H, Liu L, Gao Y, Liu P, Zhang C, Wang Z, Xie J, Wang J, Zhang X, Lu Y, Huang K, Liu M, Chen J, Gao X, Wang D, Ma X, Chen X, Li Y, Zhang Y, Kong X, Chen F, Zhang X, Qi J, Cao Y, Huang Y, Zhang Y, Cui W. Efficacy and Safety of SPH3127 Tablet, a Novel Direct Renin Inhibitor, in Patients with Mild-to-Moderate Essential Hypertension: A Phase III Randomised Trial. Drugs. 2026 May 21. doi: 10.1007/s40265-026-02315-z. Online ahead of print. |
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2 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks. |
|
| Stage 3 | Experimental | 2 SPH3127 tablets, once daily for 40 weeks. |
|
| Drug |
2 tablets |
|
| SPH3127 tablet | Drug | 4 tablets |
|
| Valsartan | Drug | 1 valsartan capsule |
|
| SPH3127 tablet | Drug | 2 tablets |
|
| Valsartan | Drug | 1 valsartan capsule |
|
| 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. |
| Plasma concentration of SPH3127. | 12 weeks. |
| Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events | 12 weeks. |
| Beijing |
| Beijing Municipality |
| 100069 |
| China |
| Beijing Pinggu Hospital | Beijing | Beijing Municipality | 101299 | China |
| Affiliated Hospital of Chongqing Three Gorges Medical College | Chongqing | Chongqing Municipality | 404037 | China |
| Lanzhou University Second Hospital | Lanzhou | Gansu | 730030 | China |
| Guangdong Second Provincial General Hospital | Guangzhou | Guangdong | 510310 | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 519041 | China |
| Liuzhou people's Hospital | Liuzhou | Guangxi | 545026 | China |
| Hainan Third People's Hospital | Sanya | Hainan | 571199 | China |
| Cangzhou Central Hospital | Cangzhou | Hebei | 061011 | China |
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050030 | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050051 | China |
| Luoyang Third People's Hospital | Luoyang | Henan | 471002 | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | 463599 | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Tongji hospital,Tongji Medical college of HUST | Wuhan | Hubei | 430030 | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
| XiangYa Hospital CentralSouth University | Changsha | Hunan | 410008 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410012 | China |
| The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology | Baotou | Inner Mongolia | 750306 | China |
| Chifeng Municipal Hospital | Chifeng | Inner Mongolia | 024099 | China |
| The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjin | Jiangsu | 210003 | China |
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| Suzhou Municipal Hospital | Suzhou | Jiangsu | 215008 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221004 | China |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | 221009 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 210031 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110022 | China |
| The People's Hospital of Liaoning Province | Shenyang | Liaoning | 110067 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750003 | China |
| The First People's Hospital of Yinchuan | Yinchuan | Ningxia | 750003 | China |
| Ruijin Hospital, Shanghai Jiaotong University School Of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| Yuncheng Central Hospital | Yuncheng | Shanxi | 044099 | China |
| West China Hospital,Sichuan University | Chengdu | Sichuan | 610044 | China |
| People's Hospital of Tianjin | Tianjin | Tianjin Municipality | 300122 | China |
| Tianjin Fourth Central Hospital | Tianjin | Tianjin Municipality | 300142 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830011 | China |
| Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Zhejiang Provincial people's Hospital | Hangzhou | Zhejiang | 314408 | China |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000709209 | SPH3127 |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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