Efficacy of SUN N4057 in Subjects With Acute Ischemic Stroke and Measurable Penumbra on Magnetic Resonance Imaging (MRI)

NCT00272909 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2015-10-20

No results posted yet for this study

Summary

This research study is designed to evaluate the safety, tolerability, and efficacy of SUN N4057 (piclozotan) in subjects with acute ischemic stroke within 9 hours of the onset of symptoms.

Conditions

Interventions

DRUG

piclozotan low dose

Continuous IV infusion over a period of up to 72 hours of piclozotan

DRUG

placebo

Continuous IV infusion over a period of up to 72 hours of placebo.

DRUG

piclozotan high dose

Continuous IV infusion over a period of up to 72 hours of piclozotan

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-10-31
Completion
2007-01-31

Countries

  • United States
  • Belgium
  • Germany
  • Israel
  • Poland
  • South Africa
  • Spain

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 NCT00272909 on ClinicalTrials.gov