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Desmoteplase in Acute Ischemic Stroke (DIAS)

NCT00638781 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2008-03-19

No results posted yet for this study

Summary

The DIAS study (Part 2) was performed to support the dose finding of desmoteplase treatment in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on MRI within a time window of 3 to 9 h after stroke-symptom onset. In addition, it assessed safety and tolerability of 3 doses of desmoteplase compared with placebo with special consideration of intracranial hemorrhage and major systemic bleedings.

Conditions

Interventions

DRUG

Desmoteplase

Desmoteplase 62.5 µg/kg BW

DRUG

Desmoteplase

Desmoteplase 90 µg/kg BW

DRUG

Desmoteplase

Desmoteplase 125 µg/kg BW

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • PAION Deutschland GmbH

    lead INDUSTRY

Principal Investigators

  • Werner Hacke, Prof. Dr. · Head of Neurology Department, University of Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-03-31
Primary Completion
2003-10-31
Completion
2003-10-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

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 NCT00638781 on ClinicalTrials.gov