Study to Evaluate the Efficacy and Safety of SPH3127 In Patients With Mild-moderate Essential Hypertension
A Multi-center, Randomized, Double-blind, Double-Dummy, Positive Parallel Controlled Study to Evaluate the Efficacy and Safety in Treatment of Mild-moderate Essential Hypertension
1 other identifier
interventional
957
1 country
40
Brief Summary
The primary aim of the study is to assess the antihypertensive efficacy of SPH3127 in patients with mild to moderate essential hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2021
Typical duration for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2021
CompletedFirst Submitted
Initial submission to the registry
April 27, 2022
CompletedFirst Posted
Study publicly available on registry
May 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2023
CompletedMay 7, 2024
June 1, 2023
2.5 years
April 27, 2022
May 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12
Measure at week 12 of treatment.
Secondary Outcomes (7)
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.
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.
- +2 more secondary outcomes
Study Arms (7)
Stage 1 Arm A
EXPERIMENTAL1 SPH3127 tablet，3 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Stage 1 Arm B
EXPERIMENTAL2 SPH3127 tablets，2 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Stage 1 Arm C
EXPERIMENTAL4 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Stage 1 Arm D
EXPERIMENTAL4 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.
Stage 2 Arm A
EXPERIMENTAL2 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Stage 2 Arm B
EXPERIMENTAL2 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.
Stage 3
EXPERIMENTAL2 SPH3127 tablets, once daily for 40 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female of age ≥18 years;
- Diagnosed with mild-moderate essential hypertension;
- Participant has understood the study-required procedures, voluntarily signed informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
Beijing Anzhen Hospital, Capital Medical University
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
Liuchow, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Changsheng Ma
Beijing Anzhen Hospital, Capitcal Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2022
First Posted
May 3, 2022
Study Start
June 10, 2021
Primary Completion
December 26, 2023
Study Completion
December 26, 2023
Last Updated
May 7, 2024
Record last verified: 2023-06