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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002806
Receipt No. R000003415
Scientific Title A Double-Blind Placebo-Controlled Asian Study of Atomoxetine Hydrochloride in the Treatment of Adult Patients with Attention-Deficit/Hyperactivity Disorder (ADHD)
Date of disclosure of the study information 2009/11/27
Last modified on 2011/05/27

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Basic information
Public title A Double-Blind Placebo-Controlled Asian Study of Atomoxetine Hydrochloride
in the Treatment of Adult Patients with Attention-Deficit/Hyperactivity
Disorder (ADHD)
Acronym A Double-Blind Placebo-Controlled Asian Study of Atomoxetine Hydrochloride
in the Treatment of Adult Patients with Attention-Deficit/Hyperactivity
Disorder (ADHD)
Scientific Title A Double-Blind Placebo-Controlled Asian Study of Atomoxetine Hydrochloride
in the Treatment of Adult Patients with Attention-Deficit/Hyperactivity
Disorder (ADHD)
Scientific Title:Acronym A Double-Blind Placebo-Controlled Asian Study of Atomoxetine Hydrochloride
in the Treatment of Adult Patients with Attention-Deficit/Hyperactivity
Disorder (ADHD)
Region
Japan Asia(except Japan)

Condition
Condition Attention-Deficit/Hyperactivity Disorder (ADHD)
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To examine the efficacy and safety of atomoxetine in adults with attention-deficit/hyperactivity disorder (ADHD)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes CAARS-Inv
Key secondary outcomes AAQOL, EQ-5D

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 atomoxetine treatment group (40-120 mg/day after the breakfast), double blind study (12 weeks)
Interventions/Control_2 control (placebo) group (after the breakfast), double blind study (12 weeks)
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Individuals with attention-deficit/ hyperactvity disorder according to DSM-IV
Key exclusion criteria Individuals with major depression or sucidal attempt
Target sample size 209

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Okada
Organization Kyoto University Hospital
Division name Day Care Unit
Zip code
Address 54 Shogoin-Kawaharacho, Sakyo, Kyoto
TEL 075-751-3384
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Okada
Organization Kyoto University Hospital
Division name Day Care Unit
Zip code
Address 54 Shogoin-Kawaharacho, Sakyo, Kyoto
TEL 075-751-3384
Homepage URL http://www.kuhp.kyoto-u.ac.jp/
Email kyopsy@kuhp.kyoto-u.ac.jp

Sponsor
Institute Eli Lilly Japan K.K.
Institute
Department

Funding Source
Organization Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 11 Month 27 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 Completed
Date of protocol fixation
2009 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 11 Month 27 Day
Last modified on
2011 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003415

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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