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

The primary aim of the study is to assess the antihypertensive efficacy of SPH3127 in patients with mild to moderate essential hypertension.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: SPH3127 tablet; Drug: SPH3127 tablet; Drug: SPH3127 tablet; Drug: Valsartan

• Study Type: Interventional
• Enrollment (Actual): 957
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Beijing Hospital
    • Beijing, Beijing, China, 100069
      • Beijing Anzhen Hospital, Capital Medical University
    • Beijing, Beijing, China, 101299
      • Beijing Pinggu Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 404037
      • Affiliated Hospital of Chongqing Three Gorges Medical College
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Lanzhou University Second Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 519041
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China, 510310
      • Guangdong Second Provincial General Hospital
  • Guangxi
    • Liuzhou, Guangxi, China, 545026
      • Liuzhou people's Hospital
  • Hainan
    • Sanya, Hainan, China, 571199
      • Hainan Third People's Hospital
  • Hebei
    • Cangzhou, Hebei, China, 061011
      • Cangzhou Central Hospital
    • Shijiazhuang, Hebei, China, 050051
      • The Third Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China, 050030
      • The First Hospital of Hebei Medical University
  • Henan
    • Luoyang, Henan, China, 471002
      • Luoyang Third People's Hospital
    • Zhengzhou, Henan, China, 463599
      • Henan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital,Tongji Medical college of Hust
  • Hunan
    • Changsha, Hunan, China, 410008
      • The Third Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410012
      • The second Xiangya hospital of central south university
    • Changsha, Hunan, China, 410008
      • XiangYa Hospital CentralSouth University
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 750306
      • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
    • Chifeng, Inner Mongolia, China, 024099
      • Chifeng Municipal Hospital
    • Hohhot, Inner Mongolia, China
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Nanjin, Jiangsu, China, 210003
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital with Nanjing Medical University
    • Suzhou, Jiangsu, China, 215008
      • Suzhou Municipal Hospital
    • Xuzhou, Jiangsu, China, 221009
      • Xuzhou Central Hospital
    • Xuzhou, Jiangsu, China, 221004
      • The Affiliated Hospital of Xuzhou Medical University
    • Zhenjiang, Jiangsu, China, 210031
      • Affiliated Hospital of Jiangsu University
  • Liaoning
    • Shenyang, Liaoning, China, 110022
      • Shengjing Hospital Of China Medical University
    • Shenyang, Liaoning, China, 110067
      • The People's Hospital of Liaoning Province
  • Ningxia
    • Yinchuan, Ningxia, China, 750003
      • General Hospital of Ningxia Medical University
    • Yinchuan, Ningxia, China, 750003
      • The First People's Hospital of Yinchuan
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Shanxi
    • Yuncheng, Shanxi, China, 044099
      • Yuncheng Central Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • West China Hospital,Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300122
      • People's Hospital of Tianjin
    • Tianjin, Tianjin, China, 300142
      • Tianjin Fourth Central Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830011
      • The first affiliated hospital of Xinjiang medical university
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 314408
      • Zhejiang Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female of age ≥18 years;
2. Diagnosed with mild-moderate essential hypertension;
3. Participant has understood the study-required procedures, voluntarily signed informed consent.

Exclusion Criteria:

1. Diagnosed with secondary hypertension, suspected grade 3 hypertension, acute hypertension, or at risk when current antihypertensive therapy discontinued;
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1 Arm A; 1 SPH3127 tablet，3 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.	Drug: SPH3127 tablet; 1 tablet; Drug: SPH3127 tablet; 2 tablets; Drug: SPH3127 tablet; 4 tablets
Experimental: Stage 1 Arm B; 2 SPH3127 tablets，2 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.	Drug: SPH3127 tablet; 1 tablet; Drug: SPH3127 tablet; 2 tablets; Drug: SPH3127 tablet; 4 tablets
Experimental: Stage 1 Arm C; 4 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.	Drug: SPH3127 tablet; 1 tablet; Drug: SPH3127 tablet; 2 tablets; Drug: SPH3127 tablet; 4 tablets
Experimental: Stage 1 Arm D; 4 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.	Drug: Valsartan; 1 valsartan capsule
Experimental: Stage 2 Arm A; 2 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.	Drug: SPH3127 tablet; 1 tablet; Drug: SPH3127 tablet; 2 tablets; Drug: SPH3127 tablet; 4 tablets
Experimental: Stage 2 Arm B; 2 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.	Drug: Valsartan; 1 valsartan capsule
Experimental: Stage 3; 2 SPH3127 tablets, once daily for 40 weeks.	Drug: SPH3127 tablet; 1 tablet; Drug: SPH3127 tablet; 2 tablets; Drug: SPH3127 tablet; 4 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12	Measure at week 12 of treatment.

Secondary Outcome Measures

Outcome Measure	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.
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.
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.
Plasma concentration of SPH3127.	12 weeks.

Collaborators and Investigators

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
• Investigators: Principal Investigator: Changsheng Ma, Beijing Anzhen Hospital, Capitcal Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): December 26, 2023
• Study Completion (Actual): December 26, 2023

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan
• Other Study ID Numbers: SPH3127-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No