Attention Deficit Hyperactivity DisorderPhase 3NCT00485459
Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD
A Phase 3 study testing Atomoxetine Hydrochloride in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 1 site in Taiwan.
Trial summary
The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Atomoxetine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2004to Nov 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
- Subjects must be aged 6 to 16 years
- Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
- Subjects must be able to swallow capsules
- Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.
Who cannot join
- Weigh less than 20 kg or more than 60 kg at study entry
- Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
- Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
- Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
- Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
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
Taipei
About this study
Official title: Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Atomoxetine Hydrochloride, Placebo
- 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
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD
Secondary outcomes (3)
Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo
Compare the reduction in school-related symptoms between atomoxetine and placebo
Assess the safety and tolerability of once-daily dosing of atomoxetine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startFeb 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485459
- Sponsor's protocol ID
- 8160
- Other IDs
- B4Z-TW-S010
- Status last verified
- Jun 2007
- First submitted
- 11 Jun 2007
- Last updated
- 13 Jun 2007
- Results posted
- No
Publications
Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.
PubMed 25019647
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00485459
- Acronym / sponsor ID
- 8160
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Nov 2004 (actual)
- First posted
- 13 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
- Subjects must be aged 6 to 16 years
- Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
- Subjects must be able to swallow capsules
- Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.
Key exclusion criteria (5 listed)
- Weigh less than 20 kg or more than 60 kg at study entry
- Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
- Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
- Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
- Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
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 Hydrochloride | Drug | – |
| Placebo | Drug | – |
Primary outcome
Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD
3 secondary outcomes
Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo
Compare the reduction in school-related symptoms between atomoxetine and placebo
Assess the safety and tolerability of once-daily dosing of atomoxetine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2007.
- Derived from this study: PubMed 25019647Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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
1 site 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 1 site in Taiwan.
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 5 inclusion and 5 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 13 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD. 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 NCT00485459, which also lists 1 linked publication.
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 13 Jun 2007.