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Study of ONO-2506 in Patients With Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT00229177
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

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.

Condition or disease Intervention/treatment Phase
Stroke Drug: ONO-2506 Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 757 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Controlled Study of ONO-2506 in Patients With Acute Ischemic Stroke
Study Start Date : September 2005
Primary Completion Date : September 2008
Study Completion Date : September 2008

Arm Intervention/treatment
Placebo Comparator: P Drug: ONO-2506
Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days
Experimental: E1 Drug: ONO-2506
Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days
Experimental: E2 Drug: ONO-2506
Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days



Primary Outcome Measures :
  1. Modified Rankin Scale at 90 days [ Time Frame: 90 days ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229177


Locations
Japan
Chubu Region Facility
Chubu, Japan
Chugoku Region Facility
Chugoku, Japan
Hokkaido Region Facility
Hokkaido, Japan
Hokuriku Region Facility
Hokuriku, Japan
Kanto Region Facility
Kanto, Japan
Kinki Region Facility
Kinki, Japan
Kyushu Region Facility
Kyushu, Japan
Shikoku Region Facility
Shikoku, Japan
Tohoku Region Facility
Tohuku, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. Ltd

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00229177     History of Changes
Other Study ID Numbers: ONO-2506-08
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-2506
stroke
Acute ischemic stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases