UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Special Drug Use-results Surveillance for long term administration in adult (18 years and older) of CONCERTA, 18mg/ 27mg/ 36mg Tablets
Title of the study (Brief title)	Special Drug Use-results Surveillance for long term administration in adult (18 years and older) of CONCERTA, 18mg/ 27mg/ 36mg Tablets
Region	Japan

Condition
Condition	Attention deficit hyperactivity disorder (ADHD)
Classification by specialty	Neurology Psychosomatic Internal Medicine Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To collect, screen or confirm or verify information related to safety and effectiveness of CONCERTA Tablets .
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety(Adverse Drug Reaction) Effectiveness(Clinical Global Impression, CAARS)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients of adult(18 years and older) with Attention deficit hyperactivity disorder (ADHD) who are treated with CONCERTA Tablets for the first time
Key exclusion criteria	Patients of continuous treatment with CONCERTA Tablets from childhood to adult with ADHD is excluded from the study of the subject
Target sample size	500

Research contact person
Name of lead principal investigator	Toshiya Kato
Organization	Janssen Pharmaceutical K.K
Division name	Safety Risk Management Dept.
Address	5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL	03-4411-5017
Email	tkato1@its.jnj.com

Public contact
Name of contact person	Keiko Imai
Organization	Janssen Pharmaceutical K.K
Division name	Safety Risk Management Dept.
Address	5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL	03-4411-5752
Homepage URL
Email	kimai4@its.jnj.com

Sponsor
Institute	Janssen Pharmaceutical K.K
Institute
Department

Funding Source
Organization	Janssen Pharmaceutical K.K
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 24 Day
Anticipated trial start date	2014 Year 06 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective study

Management information
Registered date	2014 Year 12 Month 10 Day
Last modified on	2019 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018503