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Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke

NCT00604630 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 522

Last updated 2008-10-22

No results posted yet for this study

Summary

The purpose of this randomized, double-blind, placebo-controlled multicenter study is to determine in a cohort of 506 patients with acute ischemic stroke in the middle cerebral artery territory, the effect of a three-day high-dose, intravenous erythropoietin treatment on functional outcome up to a follow-up of 90 days.

Conditions

  • Infarction, Middle Cerebral Artery
  • Middle Cerebral Artery Stroke
  • Stroke, Acute

Interventions

DRUG

recombinant human erythropoietin alfa

40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms

DRUG

0.9% NaCl

50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • Parexel

    collaborator INDUSTRY

  • Max-Planck-Institute of Experimental Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00604630 on ClinicalTrials.gov