Study of ONO-2506 in Patients With Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

757 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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P

Group Type PLACEBO_COMPARATOR

ONO-2506

Intervention Type DRUG

Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days

E1

Group Type EXPERIMENTAL

ONO-2506

Intervention Type DRUG

Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days

E2

Group Type EXPERIMENTAL

ONO-2506

Intervention Type DRUG

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

Interventions

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ONO-2506

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

Intervention Type DRUG

ONO-2506

Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days

Intervention Type DRUG

ONO-2506

Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects who have a clinical diagnosis of acute ischemic stroke
2. Subjects within 72 hours after onset of the stroke

Exclusion Criteria

1. Subjects who are scheduled to have surgical operations likely to affect the prognosis (including intravascular surgery and circulatory reconstruction)
2. Subjects who are pregnant or lactating, or who have child-bearing potential, or who wish to become pregnant.

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No