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NCT04028518

A PhaseⅡ of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke.

Status unknown Phase 2 Last updated 22 July 2019
What this trial tests

Phase 2 trial testing r-PA in Acute Ischemic Stroke in 180 participants. Status unknown.

Timeline
20 July 2019
Primary endpoint
31 October 2020
31 March 2021

Quick facts

Lead sponsorAngde Biotech Pharmaceutical Co., Ltd.
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment180
Start date20 July 2019
Primary completion31 October 2020
Estimated completion31 March 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Angde Biotech Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Acute Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this trial is to compare the efficacy of different doses of investigator product and comparator product in patients with acute ischemic stroke in 4.5 Hours after stroke onset, and provide a basis of drug administration for phase Ⅲ clinical trial. The secondary purpose of this trial is to compare the safety of different dose of investigational product and comparator product in patients with acute ischemic stroke in 4.5 hours afterstroke onset .

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Safety and Efficacy of Reteplase Versus Alteplase for Acute Ischemic Stroke: A Phase 2 Randomized Controlled Trial.
    Li S, Wang X, Jin A, Liu G, et al · · 2024 · cited 19× · PMID 38152962 · DOI 10.1161/strokeaha.123.045193
  2. Thrombolytic therapy for patients with acute ischemic stroke: systematic review and network meta-analysis of randomized trials.
    Sun LC, Li WS, Chen W, Ren Z, et al · · 2024 · cited 6× · PMID 39839875 · DOI 10.3389/fneur.2024.1490476

Verify or expand the search:

Other recruiting trials for Acute Ischemic Stroke

Currently open trials in the same condition.

Other Angde Biotech Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04028518.

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