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

May 6, 2024 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
957

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12
Time Frame: Measure at week 12 of treatment.
Measure at week 12 of treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes from baseline in mean sitting diastolic blood pressure (msDBP) at week 2, 4, 6, 8 and 10
Time Frame: Measured at week 2, 4, 6, 8 and 10 of treatment.
Measured at week 2, 4, 6, 8 and 10 of treatment.
Total effective rate at week 2, 4, 6, 8, 10 and 12
Time Frame: Measured at week 2, 4, 6, 8, 10, and 12 of treatment.
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
Time Frame: Measured at week 2, 4, 6, 8, 10, and 12 of treatment.
Measured at week 2, 4, 6, 8, 10, and 12 of treatment.
Number of subjects with adverse event.
Time Frame: 12 weeks.
12 weeks.
Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events
Time Frame: 12 weeks.
12 weeks.
Changes from baseline in mean sitting diastolic blood pressure (msSBP) at week 2, 4, 6, 8, 10 and 12.
Time Frame: Measured at week 2, 4, 6, 8, 10, and 12 of treatment.
Measured at week 2, 4, 6, 8, 10, and 12 of treatment.
Plasma concentration of SPH3127.
Time Frame: 12 weeks.
12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Pharmaceuticals Holding Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Changsheng Ma, Beijing Anzhen Hospital, Capitcal Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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