Study of ONO-2506 in Patients With Acute Ischemic Stroke

Ono Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Stroke

Treatments: Drug: ONO-2506

Study type: Interventional

Funder types: Industry

Identifiers

NCT00229177

ONO-2506-08

Details and patient eligibility

About

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

Enrollment: 757 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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.
3. Other exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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757 participants in 3 patient groups, including a placebo group

P

Placebo Comparator group

Treatment:

Drug: ONO-2506

Drug: ONO-2506

Drug: ONO-2506

E1

Experimental group

Treatment:

Drug: ONO-2506

Drug: ONO-2506

Drug: ONO-2506

E2

Experimental group

Treatment:

Drug: ONO-2506

Drug: ONO-2506

Drug: ONO-2506