UMIN ID: UMIN000000758
Registered date:02/07/2007
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
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Acute ischemic stroke (excluding cardioembolic stroke) |
| Date of first enrollment | 2007/06/01 |
| Target sample size | 770 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | AT-877 120mg/day or placebo Antiplatelet drug |
Outcome(s)
| Primary Outcome | Dichotomized mRS score |
|---|---|
| Secondary Outcome | Comparison between mRS groups, JSS-M scores |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Asahi Kasei Pharma Corporation |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Asahi Kasei Pharma Corporation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Toshiya Umeda |
| Address | 9-1 Kanda Mitoshiro-cho, Chiyoda-ku, Tokyo, Japan Japan |
| Telephone | 03-3259-5831 |
| Affiliation | Asahi Kasei Pharma Corporation Clinical Development Center |
| scientific contact | |
| Name | Norio Tanahashi |
| Address | 1397-1 Yamane, Hidaka-shi, Saitama-ken, Japan Japan |
| Telephone | |
| Affiliation | Saitama International Medical Center, Saitama University Professor, Dept. of Neurology |