Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)

NCT00856661 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2017-03-16

Study results available
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Summary

The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3 to 9 hours from onset of stroke symptoms.

Conditions

Interventions

DRUG

Desmoteplase

90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes on 1st day

DRUG

Placebo

IV, single bolus over 1 to 2 minutes on 1st day

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2014-10-31

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Denmark
  • Finland
  • Ireland
  • Italy
  • Mexico
  • Norway
  • South Africa
  • Sweden
  • United Kingdom

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 NCT00856661 on ClinicalTrials.gov