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COMPLETED
NCT06755944
PHASE2

A Phase Ⅱb Study of XY03-EA Tablets in Acute Ischemic Stroke

Sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

Summary

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase Ⅱb/Ⅲ clinical study to evaluate the efficacy and safety of XY03-EA tablets, a novel oral neuroprotective agent, and explore the dose-response relationship in patients with acute ischemic stroke. In the Phase Ⅱb stage, 360 eligible subjects were enrolled and randomly assigned to four XY03-EA dose groups and one placebo group in a 1:1:1:1:1 ratio. The primary endpoint was the proportion of patients with a modified Rankin Scale (mRS) score ≤ 1 at Day 90 after the start of study treatment.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase Ⅱb/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2024-12-15

Completion Date

2025-11-25

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DRUG

XY03-EA 150 mg (per dose)

XY03-EA tablets, 150 mg/tablet, 1 tablet orally, three times daily (Tid), for 90 days

DRUG

XY03-EA 300 mg (Regimen A)

XY03-EA tablets, 150 mg/tablet, 2 tablets orally, Tid, for 90 consecutive days

DRUG

XY03-EA 300 mg (Regimen B)

XY03-EA tablets, 150 mg/tablet, 2 tablets orally, Tid, from Day 1 to Day 14

DRUG

XY03-EA 450 mg (per dose)

XY03-EA tablets, 150 mg/tablet, 3 tablets orally, Tid, for 90 days

DRUG

Matching Placebo

Matching placebo tablets, orally, Tid, for 90 days (or as specified per arm)

Locations (1)

Shijiazhuang Yiling Pharmaceutical Co., Ltd

Shijiazhuang, Hebei, China