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Study to Evaluate the Efficacy and Safety of SPH3127 In Patients With Mild-moderate Essential Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT05359068•Shanghai Pharmaceuticals Holding Co., Ltd

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

Locations (40)

Beijing Hospital

Beijing, Beijing Municipality, China

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Pinggu Hospital

Beijing, Beijing Municipality, China

Affiliated Hospital of Chongqing Three Gorges Medical College

Chongqing, Chongqing Municipality, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Liuzhou people's Hospital

Liuchow, Guangxi, China

Hainan Third People's Hospital

Sanya, Hainan, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

Key Dates

Start Date

June 10, 2021

Primary Completion Date

December 26, 2023

Completion Date

December 26, 2023

Last Updated

May 7, 2024

Enrollment

957

ACTUAL participants

Conditions

Essential Hypertension

Interventions

SPH3127 tablet

DRUG

SPH3127 tablet

DRUG

SPH3127 tablet

DRUG

Valsartan

DRUG

SPH3127 tablet

DRUG

Valsartan

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: May 7, 2024Data 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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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