UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046038 |
|---|---|
| Receipt number | R000052541 |
| Scientific Title | Vyvanse Capsules Specified Drug Use-results Survey (Surveillance regarding pediatric use) |
| Date of disclosure of the study information | 2021/11/15 |
| Last modified on | 2024/01/12 16:22:52 |
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Basic information
Public title
Vyvanse Capsules Specified Drug Use-results Survey (Surveillance regarding pediatric use)
Acronym
Vyvanse Capsules Specified Drug Use-results Survey (Surveillance regarding pediatric use)
Scientific Title
Vyvanse Capsules Specified Drug Use-results Survey (Surveillance regarding pediatric use)
Scientific Title:Acronym
Vyvanse Capsules Specified Drug Use-results Survey (Surveillance regarding pediatric use)
Region
| Japan |
Condition
Condition
Attention deficit/hyperactivity disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To consider the effectiveness and safety of Vyvanse Capsules in pediatric use
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of physicians and teachers by the ADHD Rating Scale IV (ADHD-RS-IV) Japanese Version
Key secondary outcomes
Incidence rates of adverse drug reactions, Safety specification items
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 6 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
AD/HD patients who meet all of the following
1_Not to have experience to use Vyvanse Capsules
2_6-18 years old
3_Pre-dose efficacy in patients has been obtained
4_The consent form about joining this survey has been obtained
Key exclusion criteria
NA
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Masuyama |
Organization
Takeda Pharmaceutical Co., Ltd.
Division name
PMS Strategic Management, Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Hontyou 2-Chome, Chuo-ku Tokyo 103-8668, Japan
TEL
+81-80-1483-8274
nobuyuki.masuyama@takeda.com
Public contact
Name of contact person
| 1st name | Kouji |
| Middle name | |
| Last name | Yamashita |
Organization
Takeda Pharmaceutical Co., Ltd.
Division name
PMS Strategic Management, Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Hontyou 2-Chome, Chuo-ku Tokyo 103-8668, Japan
TEL
+81-80-4324-2955
Homepage URL
kouji.yamashita@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
NO
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
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
| 2021 | Year | 11 | Month | 15 | 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
88
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research ethics review is not necessary
The marketing approval of this drug was transferred to Takeda Pharmaceutical Company Limited. on November 30, 2023
Management information
Registered date
| 2021 | Year | 11 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052541
