NCT05515393

A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke

A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled, Dose-exploration Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Overall Design: a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-exploration study. Main outcome: 1.To evaluate the efficacy and safety of XY03-EA tablets in the treatment of acute ischemic stroke.

Detailed description

The population is patient who with acute ischemic stroke within 48 hours of onset (including RT-PA intravenous thrombolytic therapy) . The patients were randomized based on being received rt-PA Intravenous thrombolysis or not. Patients who met the inclusion criteria for the protocol were stratified randomly and assigned in a 1:1:1 ratio to three groups: the XY03-EA 300mg, 600mg two-dose group, and the placebo group. The study was divided into 3 stages: screening stage, treatment stage and follow-up stage. The sample size was 420 patients. Main outcome: 1.To evaluate the efficacy and safety of XY03-EA tablets in the treatment of acute ischemic stroke. Secondary outcome: 1. Explore the dose-response relationship of XY03-EA tablets in the treatment of acute ischemic stroke, and provide data support for later clinical study; 2. Explore PK characteristics of XY03-EA and its metabolites in patients with acute ischemic stroke based on population PK analysis method.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	XY03-EA	The sample size was 420 patients, and 140 patients were treated with XY03-EA 300 mg, 600 mg and placebo respectively. The 300-mg group took two tablets of placebo and two tablets of XY03-EA once, three times a day. The 600-mg group took four tablets of XY03-EA once, three times a day. The placebo group took four tablets of placebo once ,three times a day.
DRUG	XY03-EA Placebo	XY03-EA Placebo

Timeline

• Start date: 2022-09-24
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2022-08-25
• Last updated: 2023-06-22

Locations

1 site across 1 country: China