Attention Deficit Hyperactivity DisorderPhase 3NCT00191659
Study of Broader Efficacy of Atomoxetine in the Treatment of ADHD in Children/Adolescents
A Phase 3 study testing Atomoxetine Hydrochloride in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial summary
To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine hydrochloride in comparison to standard current therapies have greater improvements in their quality of life. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Atomoxetine Hydrochloride
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2004to Apr 2006
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of ADHD
Who cannot join
- Patients who weigh less than 20kg at visit 1
- Have Bipolar Disorder/seizure disorder/taken anticonvulsants for seizures
- Judged to be at suicidal risk
- Taking psychotropic medication on a regular basis
- Hypertension
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Basingstoke, Hampshire, RG24 9NL
About this study
Official title: A Randomised, Controlled, Open-Label Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents
To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine hydrochloride in comparison to standard current therapies have greater improvements in their quality of life.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition)
Secondary outcomes (10)
CHIP-CE total mean score after 4 weeks of treatment.
The domains of the CHIP-CE after 4 and 10 weeks of treatment.
The following are measured after both 4 and 10 weeks of treatment:
Family Buden of Illness
Harter Self Perception Profile
ADHD-RS
Clinical Global Impression- Severity
Clinical Global Impression -Improvement
To assess whether changes to the above scales are maintained over long term
Long-term safety of atomoxetine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 200 participants
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
- NCT00191659
- Sponsor's protocol ID
- 6962
- Other IDs
- B4Z-BP-LYBS
- Status last verified
- Feb 2007
- First submitted
- 12 Sep 2005
- Last updated
- 2 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Open-Label Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00191659
- Acronym / sponsor ID
- 6962
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Apr 2006
- First posted
- 19 Sep 2005 (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.
To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine hydrochloride in comparison to standard current therapies have greater improvements in their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of ADHD
Key exclusion criteria (5 listed)
- Patients who weigh less than 20kg at visit 1
- Have Bipolar Disorder/seizure disorder/taken anticonvulsants for seizures
- Judged to be at suicidal risk
- Taking psychotropic medication on a regular basis
- Hypertension
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 | – |
Primary outcome
To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition)
10 secondary outcomes
CHIP-CE total mean score after 4 weeks of treatment.
The domains of the CHIP-CE after 4 and 10 weeks of treatment.
The following are measured after both 4 and 10 weeks of treatment:
Family Buden of Illness
Harter Self Perception Profile
ADHD-RS
Clinical Global Impression- Severity
Clinical Global Impression -Improvement
To assess whether changes to the above scales are maintained over long term
Long-term safety 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 2 Mar 2007.
- 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 United Kingdom.
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 1 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 2 Mar 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 United Kingdom. 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?
To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2007.