UMIN ID: UMIN000039018
Registered date:06/01/2020
Vyvanse Capsules Specified Drug Use-results Survey (Surveillance regarding pediatric long-term use)
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Attention deficit/hyperactivity disorder |
| Date of first enrollment | 2020/01/07 |
| Target sample size | 1500 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | (1) Safety Incidence rates of adverse drug reactions, Safety specification items of Vyvanse Capsules (2) Efficacy Evaluation of physicians by the ADHD Rating Scale IV (ADHD RS-IV) Japanese Version |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 6years-old |
|---|---|
| Age maximum | 18years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | NA |
Related Information
| Primary Sponsor | Takeda Pharmaceutical Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Takeda Pharmaceutical Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kouji Yamashita |
| Address | 1-1, Nihonbashi-Hontyou 2-Chome, Chuo-ku Tokyo 103-8668, Japan 103-8668 |
| Telephone | +81-80-4324-2955 |
| kouji.yamashita@takeda.com | |
| Affiliation | Takeda Pharmaceutical Co., Ltd. PMS Strategic Management, Japan Medical Office |
| scientific contact | |
| Name | Nobuyuki Masuyama |
| Address | 1-1, Nihonbashi-Hontyou 2-Chome, Chuo-ku Tokyo 103-8668, Japan |
| Telephone | +81-80-1483-8274 |
| nobuyuki.masuyama@takeda.com | |
| Affiliation | Takeda Pharmaceutical Co., Ltd. PMS Strategic Management, Japan Medical Office |