Clinical Trials Directory

Trials / Completed

CompletedNCT03971929

Safety and Effect Study of SHR0532 (Drug Code) Tablets in Patients With Mild Hypertension

A Phase I, Randomized, Double-Blind, Placebo-hydrochlorothiazide Parallel Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Efficacy of SHR 0532 Oral Tablets in Mild Hypertension Subjects

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Jiangsu HengRui Medicine Co., Ltd. · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The study is being conducted to evaluate the safety and efficacy and Pharmacokinetics/Pharmacodynamics of SHR0532 in subjects with mild hypertension for 4 weeks.

Detailed description

This is a randomized, double-blind, multiple ascending dose, placebo- and Hydrochlorothiazide-controlled study to evaluate the safety and tolerability, Pharmacokinetics and Pharmacodynamics and effect on blood pressure of SHR0532 tablets in patients with mild hypertension.

Conditions

Interventions

TypeNameDescription
DRUGSHR0532once daily(QD) for 4weeks
DRUGSHR placeboonce daily(QD) for 4weeks
DRUGHydrochlorothiazide 25 mgonce daily(QD) for 4weeks

Timeline

Start date
2019-07-31
Primary completion
2020-09-03
Completion
2020-09-03
First posted
2019-06-03
Last updated
2021-10-18

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03971929. Inclusion in this directory is not an endorsement.