Attention Deficit Hyperactivity DisorderPhase 3NCT00191386

Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)

A Phase 3 study testing Atomoxetine hydrochloride in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 24 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study is long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD). Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder
What is being tested?: Atomoxetine hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 228 participants
Where: 24 sitesJapan
Study dates: May 2005to Aug 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients who met all of the disease diagnostic and study criteria at Visit 2 of previous placebo-controlled study, completed the study
Patients wish to enter into this study

Who cannot join

Patients whose families anticipate a move outside the geographic range of the investigative site, or who plan extended travel inconsistent with the recommended visit interval

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

Japan24 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aichi
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Chiba
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Fukui
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Fukuoka
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Hokkaido
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Hyōgo
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Ibaraki
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Ishikawa
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Kanagawa
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Kumamoto
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Mie
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Miyagi
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Nagano
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Nara
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Okayama
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Osaka
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Saga
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Shiga
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Shizuoka
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Tochigi
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Tokushima
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Tokyo
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Toyama
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Wakayama

Other trials in Japan

About this study

Official title: Long-Term Extension, Open-Label Study of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder

The study is long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD).

Conditions: Attention Deficit Hyperactivity Disorder
Being tested: Atomoxetine hydrochloride
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Atomoxetine hydrochlorideDrug
Also called LY139603, Strattera
0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years

Study groups in NCT00191386
Study group	Role	What they receive
Atomoxetine	Experimental	0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years Receives: Drug: Atomoxetine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events for Long Term Safety and Tolerability
Details on the actual adverse events are presented in the Reported Adverse Events Section.
Measured: Baseline through 4 years

Secondary outcomes (3)

Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
Measured: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years
Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)
Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Measured: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years
Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Participants were categorized as either extensive metabolizers (EM) or poor metabolizers (PM). CYP2D6 is the primary atomoxetine metabolizing enzyme. The CYP2D6 genotype were analysed by testing the *2, *3, *4, *5, *6, *7, *8, and *10 alleles. Metabolizer status was determined by focusing on the normal(wild type, *2), decreased(*10), and defective allele(*3, *4, *5, *6, *7, or *8). PM were assigned to the patients had two defective alleles in any combination of *3, *4, *5, *6, *7, or *8 alleles. EM was all except for PM.
Measured: Over 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2005Aug 2009

First posted19 Sep 2005 (estimated)
Study startMay 2005
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00191386
Sponsor's protocol ID: 9315
Other IDs: B4Z-JE-LYDA
Status last verified: Dec 2010
First submitted: 12 Sep 2005
Last updated: 28 Dec 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 3
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All Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-Term Extension, Open-Label Study of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder
ClinicalTrials.gov ID: NCT00191386
Acronym / sponsor ID: 9315
Conditions: Attention Deficit Hyperactivity Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 228 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 19 Sep 2005 (estimated)
Results: Posted 10 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study is long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Atomoxetine	Experimental	Drug: Atomoxetine hydrochloride0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Patients who met all of the disease diagnostic and study criteria at Visit 2 of previous placebo-controlled study, completed the study
Patients wish to enter into this study

Key exclusion criteria (1 listed)

Patients whose families anticipate a move outside the geographic range of the investigative site, or who plan extended travel inconsistent with the recommended visit interval

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Atomoxetine hydrochlorideAlso: LY139603, Strattera0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years	Drug	Atomoxetine

Primary outcome

Number of Participants With Adverse Events for Long Term Safety and Tolerability
Time frame: Baseline through 4 years
Details on the actual adverse events are presented in the Reported Adverse Events Section.

3 secondary outcomes

Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score
Time frame: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years
Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)
Time frame: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years
Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Time frame: Over 1 year

Results and safety

Results posted to the registry on 10 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atomoxetine	228	68

Primary outcome: Number of Participants With Adverse Events for Long Term Safety and Tolerability

Time frame: Baseline through 4 years. Number. Unit: Participants

Measure	Atomoxetine n = 228
Serious Adverse Events	6
All Other Nonserious Adverse Events	222

Population analysed: All patients who took at least one dose of study medication were included in the analyses of safety data.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atomoxetine	6 of 228 (2.6%)	222 of 228 (97.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Attention Deficit Hyperactivity Disorder

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atomoxetine hydrochloride in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 24 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events for Long Term Safety and Tolerability (time frame: Baseline through 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00191386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2010.