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Essential HypertensionPhase 3NCT05359068

Study to Evaluate the Efficacy and Safety of SPH3127 In Patients With Mild-moderate Essential Hypertension

A Phase 3 study testing SPH3127 tablet and Valsartan in people with Essential Hypertension, run by Shanghai Pharmaceuticals Holding Co., Ltd at 40 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Essential Hypertension
What is being tested?
SPH3127 tablet and Valsartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
957 participants
Where
40 sitesChina
Study dates
10 Jun 2021to 26 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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;
Show all 11Show fewer
  • 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.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

China40 sites

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

    Baotou, Inner Mongolia, 750306

  • Beijing Hospital

    Beijing, Beijing Municipality, 100005

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100069

  • Beijing Pinggu Hospital

    Beijing, Beijing Municipality, 101299

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061011

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • XiangYa Hospital CentralSouth University

    Changsha, Hunan, 410008

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410012

  • West China Hospital,Sichuan University

    Chengdu, Sichuan, 610044

  • Chifeng Municipal Hospital

    Chifeng, Inner Mongolia, 024099

  • Affiliated Hospital of Chongqing Three Gorges Medical College

    Chongqing, Chongqing Municipality, 404037

  • Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong, 510310

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 519041

  • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Provincial people's Hospital

    Hangzhou, Zhejiang, 314408

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Liuzhou people's Hospital

    Liuzhou, Guangxi, 545026

  • Luoyang Third People's Hospital

    Luoyang, Henan, 471002

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjin, Jiangsu, 210003

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Hainan Third People's Hospital

    Sanya, Hainan, 571199

  • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110022

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning, 110067

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050030

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu, 215008

  • People's Hospital of Tianjin

    Tianjin, Tianjin Municipality, 300122

  • Tianjin Fourth Central Hospital

    Tianjin, Tianjin Municipality, 300142

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Tongji hospital,Tongji Medical college of HUST

    Wuhan, Hubei, 430030

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221004

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750003

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia, 750003

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044099

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 463599

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 210031

Other trials in China

About this study

Official title: 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.

Being tested
SPH3127 tablet, Valsartan
Medical subject headings
Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPH3127 tabletDrug

    1 tablet

  • SPH3127 tabletDrug

    2 tablets

  • SPH3127 tabletDrug

    4 tablets

  • ValsartanDrug

    1 valsartan capsule

  • SPH3127 tabletDrug

    2 tablets

  • ValsartanDrug

    1 valsartan capsule

Study groups in NCT05359068
Study groupRoleWhat they receive
Stage 1 Arm AExperimental1 SPH3127 tablet，3 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Receives: Drug: SPH3127 tablet
Stage 1 Arm BExperimental2 SPH3127 tablets，2 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Receives: Drug: SPH3127 tablet
Stage 1 Arm CExperimental4 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Receives: Drug: SPH3127 tablet
Stage 1 Arm DExperimental4 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.
Receives: Drug: Valsartan
Stage 2 Arm AExperimental2 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Receives: Drug: SPH3127 tablet
Stage 2 Arm BExperimental2 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.
Receives: Drug: Valsartan
Stage 3Experimental2 SPH3127 tablets, once daily for 40 weeks.
Receives: Drug: SPH3127 tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12

    Measured: Measure at week 12 of treatment.

Secondary outcomes (7)

  1. Changes from baseline in mean sitting diastolic blood pressure (msDBP) at week 2, 4, 6, 8 and 10

    Measured: Measured at week 2, 4, 6, 8 and 10 of treatment.

  2. Changes from baseline in mean sitting diastolic blood pressure (msSBP) at week 2, 4, 6, 8, 10 and 12.

    Measured: Measured at week 2, 4, 6, 8, 10, and 12 of treatment.

  3. Total effective rate at week 2, 4, 6, 8, 10 and 12

    Measured: Measured at week 2, 4, 6, 8, 10, and 12 of treatment.

  4. Rate of reaching target blood pressure at week 2, 4, 6, 8, 10 and 12

    Measured: Measured at week 2, 4, 6, 8, 10, and 12 of treatment.

  5. Number of subjects with adverse event.

    Measured: 12 weeks.

  6. Plasma concentration of SPH3127.

    Measured: 12 weeks.

  7. Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events

    Measured: 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start10 Jun 2021
  3. Primary completion26 Dec 2023
  4. Study completion26 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
957 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05359068
Sponsor's protocol ID
SPH3127-301
Status last verified
Jun 2023
First submitted
27 Apr 2022
Last updated
7 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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 Jul;86(7):1121-1132. doi: 10.1007/s40265-026-02315-z. Epub 2026 May 21.

    PubMed 42165988

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPH3127 tablet and Valsartan in people with Essential Hypertension, run by Shanghai Pharmaceuticals Holding Co., Ltd at 40 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12 (time frame: Measure at week 12 of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05359068, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.

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