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 |
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
Phase III clinical trial for AT-877 (i.v.) in acute ischemic stroke
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
Phase III clinical trial for AT-877 (i.v.) in acute ischemic stroke
Japan |
Acute ischemic stroke (excluding cardioembolic stroke)
Medicine in general | Cardiology | Neurology |
Neurosurgery | Emergency medicine | Intensive care medicine |
Rehabilitation medicine |
Others
NO
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.
Safety,Efficacy
Confirmatory
Explanatory
Phase III
Dichotomized mRS score
Comparison between mRS groups, JSS-M scores
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
YES
NO
No need to know
2
Treatment
Medicine |
AT-877 120mg/day or placebo
Antiplatelet drug
20 | years-old | <= |
Not applicable |
Male and Female
(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
(1) Patients having a history of coronary, renal, hepatic or metabolic disease. Patients exhibiting dysemia
(2) Other conditons at the discretion of the investigator
770
1st name | |
Middle name | |
Last name | Norio Tanahashi |
Saitama International Medical Center, Saitama University
Professor, Dept. of Neurology
1397-1 Yamane, Hidaka-shi, Saitama-ken, Japan
1st name | |
Middle name | |
Last name | Toshiya Umeda |
Asahi Kasei Pharma Corporation
Clinical Development Center
9-1 Kanda Mitoshiro-cho, Chiyoda-ku, Tokyo, Japan
03-3259-5831
Asahi Kasei Pharma Corporation
Asahi Kasei Pharma Corporation
Profit organization
Japan
NO
2007 | Year | 07 | Month | 02 | Day |
Unpublished
Completed
2007 | Year | 03 | Month | 15 | Day |
2007 | Year | 06 | Month | 01 | Day |
2010 | Year | 01 | Month | 01 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 04 | Month | 01 | Day |
2007 | Year | 07 | Month | 02 | Day |
2010 | Year | 06 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000909