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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039018
Receipt No. R000044493
Scientific Title Vyvanse Capsules Specified Drug Use-results Survey (Surveillance regarding pediatric long-term use)
Date of disclosure of the study information 2020/01/06
Last modified on 2020/02/20

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Basic information
Public title Vyvanse Capsules Specified Drug Use-results Survey (Surveillance regarding pediatric long-term use)
Acronym Vyvanse Capsules Specified Drug Use-results Survey (Surveillance regarding pediatric long-term use)
Scientific Title Vyvanse Capsules Specified Drug Use-results Survey (Surveillance regarding pediatric long-term use)
Scientific Title:Acronym Vyvanse Capsules Specified Drug Use-results Survey (Surveillance regarding pediatric long-term use)
Region
Japan

Condition
Condition Attention deficit/hyperactivity disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluateconsider the safety and efficacy of Vyvanse Capsules for pediatric patient with Attention deficit/hyperactivity disorder in pediatric long-term use.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes (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
Key secondary outcomes

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 Patients with attention deficit/hyperactivity disorder (AD/HD) between 6 and 18 years of age without prior exposure to Vyvanse Capsules.
Key exclusion criteria NA
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Masaru
Middle name
Last name Sawada
Organization Shionogi & Co., Ltd.

Division name Pharmacovigilance Department
Zip code 541-0045
Address 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
TEL +81-6-6209-6974
Email masaru.sawada@shionogi.co.jp

Public contact
Name of contact person
1st name Masakazu
Middle name
Last name Notohara
Organization Shionogi & Co., Ltd.
Division name Pharmacovigilance Department
Zip code 541-0045
Address 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
TEL +81-6-6209-6929
Homepage URL
Email masakazu.notohara@shionogi.co.jp

Sponsor
Institute Shionogi & Co., Ltd.
Institute
Department

Funding Source
Organization Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Takeda Pharmaceutical Company Limited
Name of secondary funder(s)

IRB Contact (For public release)
Organization NA
Address NA
Tel NA
Email 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
2020 Year 01 Month 06 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 Open public recruiting
Date of protocol fixation
2019 Year 11 Month 30 Day
Date of IRB
2019 Year 12 Month 28 Day
Anticipated trial start date
2020 Year 01 Month 07 Day
Last follow-up date
2026 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2019 Year 12 Month 27 Day
Last modified on
2020 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044493

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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