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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000758
Receipt No. R000000909
Scientific Title Phase III clinical trial for AT-877 (i.v.) in patients with acute ischemic stroke. Placebo-controlled, double-blind add-on therapy to antiplatelet drugs
Date of disclosure of the study information 2007/07/02
Last modified on 2010/06/03

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Basic information
Public title Phase III clinical trial for AT-877 (i.v.) in patients with acute ischemic stroke. Placebo-controlled, double-blind add-on therapy to antiplatelet drugs
Acronym Phase III clinical trial for AT-877 (i.v.) in acute ischemic stroke
Scientific Title Phase III clinical trial for AT-877 (i.v.) in patients with acute ischemic stroke. Placebo-controlled, double-blind add-on therapy to antiplatelet drugs
Scientific Title:Acronym Phase III clinical trial for AT-877 (i.v.) in acute ischemic stroke
Region
Japan

Condition
Condition Acute ischemic stroke (excluding cardioembolic stroke)
Classification by specialty
Medicine in general Cardiology Neurology
Neurosurgery Emergency medicine Intensive care medicine
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of AT-877 at 120 mg/day administered intravenously in acute ischemic stroke patients (excluding those with cardioembolic stroke) in a double-blind study with concommitant administration of an antiplatelet drug.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Dichotomized mRS score
Key secondary outcomes Comparison between mRS groups, JSS-M scores

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 AT-877 120mg/day or placebo
Interventions/Control_2 Antiplatelet drug
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) 20 y/o or older upon informed consent
(2) Male or female
(3) Hospitalization
(4) Patients with acute ischemic stroke (excluding cardioembolic stroke) occurring within 48 hrs. of admission
Key exclusion criteria (1) Patients having a history of coronary, renal, hepatic or metabolic disease. Patients exhibiting dysemia
(2) Other conditons at the discretion of the investigator
Target sample size 770

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Tanahashi
Organization Saitama International Medical Center, Saitama University
Division name Professor, Dept. of Neurology
Zip code
Address 1397-1 Yamane, Hidaka-shi, Saitama-ken, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshiya Umeda
Organization Asahi Kasei Pharma Corporation
Division name Clinical Development Center
Zip code
Address 9-1 Kanda Mitoshiro-cho, Chiyoda-ku, Tokyo, Japan
TEL 03-3259-5831
Homepage URL
Email

Sponsor
Institute Asahi Kasei Pharma Corporation
Institute
Department

Funding Source
Organization Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 07 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2010 Year 01 Month 01 Day
Date of closure to data entry
2010 Year 04 Month 01 Day
Date trial data considered complete
2010 Year 04 Month 01 Day
Date analysis concluded
2010 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 07 Month 02 Day
Last modified on
2010 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000909

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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