deltatrials
Recruiting PHASE3 INTERVENTIONAL 2-arm NCT06660719

Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care (SP-8203-3001)

A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase III Clinical Study to Evaluate Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Requiring Thrombolytic Therapy as Standard of Care

Sponsor: Shin Poong Pharmaceutical Co. Ltd.

Conditions Ischemic Stroke
Interventions Placebo SP-8203
Updated 3 times since 2024 Last updated: Mar 4, 2025 Started: Feb 14, 2025 Primary completion: Mar 30, 2027 Completion: Mar 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT06660719, this PHASE3 trial focuses on Ischemic Stroke and remains actively recruiting participants. Sponsored by Shin Poong Pharmaceutical Co. Ltd., it has been updated 3 times since 2025, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Nov 2024 – ~Apr 2025 · 5 months · monthly snapshotNot Yet Recruiting~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshotRecruiting~Sep 2025 – present · 10 months · monthly snapshotRecruiting

Change History

3 versions recorded

  1. Sep 2025 — Present [monthly]

    Recruiting PHASE3

  2. Apr 2025 — Sep 2025 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  3. Nov 2024 — Apr 2025 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shin Poong Pharmaceutical Co. Ltd.
Data source: Shin Poong Pharmaceutical Co. Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations