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

NCT03756103 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-11-15

No results posted yet for this study

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.

Conditions

  • Hypertension,Essential

Interventions

DRUG

SPH3127 tablet Dose 1

Oral SPH3127 tablet, a kind of renion inhibitor, 50 mg, once daily for 8 weeks.

DRUG

SPH3127 tablet Dose 2

Oral SPH3127 tablet, a kind of renion inhibitor, 100 mg, once daily for 8 weeks.

DRUG

SPH3127 tablet Dose 3

Oral SPH3127 tablet, a kind of renion inhibitor, 200 mg, once daily for 8 weeks.

DRUG

SPH3127 tablet Placebo

Oral SPH3127 tablet placebo, once daily for 8 weeks.

Sponsors & Collaborators

  • R&G Pharma Studies Co.,Ltd.

    collaborator INDUSTRY

  • Shanghai Pharmaceuticals Holding Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Changsheng Ma, Doctor · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-11
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03756103 on ClinicalTrials.gov