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COMPLETEDPHASE2

Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients

To Evaluate the Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients: A Randomized, Double-Blinded, Dose-Exploration and Placebo-Controlled Study

NCT03756103•Shanghai Pharmaceuticals Holding Co., Ltd

View on ClinicalTrials.gov

Summary

SPH3127 tablet is a of renin inhibitor. It is expected to be a new drug for essential hypertension. This is a phase IIa trial which designed to evaluate its efficacy and safety on treating mild-moderate essential hypertension patients.

Detailed Description

This is a dose finding trial. Totally 120 mild-moderate essential hypertension patients will be enrolled. All the patients will be randomized (1:1:1:1) into four groups (SPH3127 50mg, SPH3127 100mg, SPH3127 200mg and placebo). The trial has three phases: the screening phase, the leading phase and the treating phase. The primary endpoints are the changes of DBP and SBP compared to the baseline after 8 weeks of treatment. All the adverse events are required to be collected for safety analyzing.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female who is 18 - 65 years old.
•2. Subject who is meeting the diagnostic criteria of mild-moderate essential hypertension：mean seated Systolic Blood Pressure (SBP) (2\~3 times average) ≥ 140 mmHg and ≤ 179 mmHg and mean seated Diastolic Blood Pressure (DBP) (2\~3 times average)≥ 90 and ≤ 109 mmHg.
•3. Laboratory testing should:
•（1） GFR\* ≥ 60mL/min （2） AST or ALT is less than 2 times upper limit of normal （3） Hemoglobin ≥ 90g/L （4） Serum potassium ≥ 3.5mmol/L and ≤ 5.5mmol/L \*the conversion formulas for GFR\* Male：GFR=186×（Scr)\^-1.154×(age)\^-0.203； Female：GFR=186×（Scr)\^-1.154×(age)\^-0.203×0.742； Serum creatinine(Scr) unit：µmol/L.

Exclusion Criteria

•1. Subject who is diagnosed as a secondary hypertension.
•2. Subject who is suspected to be malignant hypertension, hypertensive emergency, hypertensive urgencies patients.
•3. Subject who is at risk when the current anti-hypertensive therapy discontinued.
•4. Subject who is suffered by chronic congestive heart failure (NYHA III and IV) or myocardial infarction within 6 months. Subject has had or is currently suffered by serious heart disease, such as unstable angina, cardiogenic shock, arrhythmia to that needs treatment, heart valve disease, hypertrophic cardiomyopathy, rheumatic heart disease, etc.
•5. Subject who is suffered by severe cerebrovascular disease or shock within 6 months, such as hypertensive encephalopathy, cerebrovascular injury, cerebral hemorrhage, transient ischemic attack etc.
•6. Subject who is suffered by severe or malignant retinopathy. The severe lesions is defined as retinal hemorrhage, micro aneurysm, cotton wool patches, hard exudate or a combination of these symptoms. The malignant lesions defined as the combination of severe retinopathy and optic disc edema.
•7. Subject's medication compliance is not suitable for this trial (use of medication is \<80% or \>120% in the leading phase).
•8. Subject whose work is associated with such condition as work at height, motor driver or operating dangerous machine etc.
•9. Subject who is suffered by aorta-arteritis, large aneurysm or aortic dissection, severe subclavian artery stenosis in the past.
•10. Subject who had a gastrointestinal surgery history that may significantly alter drug absorption, distribution, metabolism and excretion（For example: gastroectomy, gastroenteroanastomosis or enterectomy, gastric bypass, gastrointestinal anastomosis, gastrointestinal band surgery, etc.).
+11 more criteria

Locations (10)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Beijing Hospital

Beijing, China

The Second Xiangya Hospital of Central South University

Changsha, China

Xiangya Hospital Central South University

Changsha, China

West China Hospital of Sichuan University

Chengdu, China

Second People's Hospital of Guangdong Province

Guangdong, China

Inner Mongolia Medical University Affiliated Hospital

Hohhot, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

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

Wuhan, China

Xuzhou Central Hospital

Xuzhou, China

Key Dates

Start Date

January 11, 2019

Primary Completion Date

June 30, 2020

Completion Date

June 30, 2020

Last Updated

November 15, 2021

Enrollment

120

ACTUAL participants

Conditions

Hypertension,Essential

Interventions

SPH3127 tablet Dose 1

DRUG

SPH3127 tablet Dose 2

DRUG

SPH3127 tablet Dose 3

DRUG

SPH3127 tablet Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients

Inclusion Criteria

Exclusion Criteria

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