NCT03756103

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension,Essential

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-11
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2018-11-28
• Last updated: 2021-11-15

Locations

10 sites across 1 country: China