UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000758 |
|---|---|
| Receipt number | 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 13:02:55 |
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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
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
Sponsor or person
Institute
Asahi Kasei Pharma Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000909
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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