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Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS)

NCT00638248 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2008-03-19

No results posted yet for this study

Summary

The purpose of this study was to explore trends in safety and efficacy, and to find the optimal dose for the subsequent phase III trial. The decision to initiate the phase III trial will depend on both safety (incidence of symptomatic intracranial hemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles. The safety (incidence of symptomatic intracranial haemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles gained from this study were the basis of planning the phase III.

Conditions

Interventions

DRUG

Desmoteplase

Desmoteplase 90µg/kg BW i.v. bolus

DRUG

Desmoteplase

Desmoteplase 125 µg/kg BW i.v. bolus

DRUG

Placebo

Placebo i.v. bolus

Sponsors & Collaborators

  • PAION Deutschland GmbH

    lead INDUSTRY

Principal Investigators

  • Antony J. Furlan, MD · Department of Neurology; the Cleveland Clinic Foundation

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
2003-03-31
Primary Completion
2004-10-31
Completion
2004-10-31

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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 NCT00638248 on ClinicalTrials.gov