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Completed

NCT Number: NCT00229177

Study of ONO-2506 in Patients With Acute Ischemic Stroke

The purpose of this study is to determine the efficacy and safety of ONO-2506 compared to placebo in patients with acute ischemic stroke.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chugoku Region Facility, Chugoku, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who have a clinical diagnosis of acute ischemic stroke
  • Subjects within 72 hours after onset of the stroke
  • Other inclusion criteria may apply.

Exclusion criteria

  • Subjects who are scheduled to have surgical operations likely to affect the prognosis (including intravascular surgery and circulatory reconstruction)
  • Subjects who are pregnant or lactating, or who have child-bearing potential, or who wish to become pregnant.
  • Other exclusion criteria may apply.

Treatment and study plan

ONO-2506

Drug

Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days

Primary outcomes

  1. Modified Rankin Scale at 90 days

    Time frame: 90 days

Secondary outcomes

  1. Modified Rankin Scale at 30 days

    Time frame: 30 days

  2. National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Controlled Study of ONO-2506 in Patients With Acute Ischemic Stroke

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 29, 2005
Registry last updated
Jun 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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