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

Hypertension,Essential Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03756103
Study type Interventional
Source Shanghai Pharmaceuticals Holding Co., Ltd
Contact
Status Completed
Phase Phase 2
Start date January 11, 2019
Completion date June 30, 2020
View Details
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