Study of ONO-2506 in Patients With Acute Ischemic Stroke | NCT00229177

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

NCT00229177

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jun 13, 2012Estimated

Enrollment

757Actual

Phase

Phase 2Phase 3

Conditions

Stroke

Interventions

ONO-2506
ONO-2506
ONO-2506

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Sep 27, 2005

First Submission Date that Met QC Criteria

Sep 27, 2005

First Posted Date

Sep 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2012

Last Update Posted Date

Jun 13, 2012Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

757Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
P	Placebo Comparator	Drug: ONO-2506
E1	Experimental	Drug: ONO-2506
E2	Experimental	Drug: ONO-2506

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ONO-2506	Drug	Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days	E2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Modified Rankin Scale at 90 days		90 days

Secondary Outcomes

Measure	Description	Time Frame
Modified Rankin Scale at 30 days		30 days
National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days		90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Project Leader, Development Planning	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chugoku Region Facility		Chugoku			Japan
Chubu Region Facility

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C459360	ONO2506

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided