UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039018
Receipt number 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 2024/01/12 16:07:15

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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 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

Email

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


Email

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)



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

1820

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

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

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=R000044493


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name