Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-06-26 @ 5:15 AM
Study NCT ID:
NCT03756103
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2018-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients
Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: