- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00406354
Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany
February 19, 2010 updated by: Eli Lilly and Company
A Randomized, Double-Blind Comparison of Atomoxetine Versus Placebo in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder
A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to compare the efficacy and safety of atomoxetine versus placebo in children and adolescents aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant disorder (ODD) who are treated as outpatients in Germany.
After an initial 3- to 28-day screening and washout phase, participants will be assigned to double-blind treatment with atomoxetine or placebo.
A 2 week up-titration period will be succeeded by a 7 week treatment period at the target dose.
The primary efficacy measure will be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
181
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 10789
- 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.
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Dusseldorf, Germany, 40215
- 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.
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Fulda, Germany, 36037
- 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.
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Hamburg, Germany, 22459
- 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.
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Heppenheim, Germany, 64646
- 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.
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Munchen, Germany, 80639
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female outpatients who are at least 6 years of age, and who will not have reached their 18th birthday
- Diagnosis of ADHD and presence of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria A through C for ODD (NOTE: diagnosis for conduct disorder not exclusionary)
- Normal intelligence
- Able to swallow capsules
Exclusion Criteria:
- Weigh less than 20 kilogram (kg) or more than 90 kg at study entry
- Prior treatment with atomoxetine
- History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
- History of severe allergies or multiple adverse drug reactions
- Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT (measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle) prolongation , inherited cardiac disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Atomoxetine Fast Titration
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
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Dosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules.
Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks.
Other Names:
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Experimental: Atomoxetine Slow Titration
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
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Dosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules.
Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks.
Other Names:
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Placebo Comparator: Placebo
matching placebo daily dose taken orally
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Double-blind treatment will consist of 3 matching placebo capsules taken once per day by mouth for approximately 9 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score
Time Frame: 9 weeks
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The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD.
Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much).
The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24).
SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54.
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9 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score
Time Frame: 9 weeks
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The SNAP-IV: ADHD Combined Subscale for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much).
The lowest possible score is 0; highest is 54.
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9 weeks
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Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score
Time Frame: 9 weeks
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The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much).
The lowest possible score is 0; highest is 27.
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9 weeks
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Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score
Time Frame: 9 weeks
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The SNAP-IV: ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much).
The lowest possible score is 0; highest is 27.
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9 weeks
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Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity
Time Frame: 9 weeks
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FBB-HKS ("Fremdbeurteilungsbogen fur Hyperkinetische Storungen"), the German, parent-rated scale for attention-deficit, is a 20-item rating scale which describes ADHD symptom criteria of DSM-IV and is grouped based upon the 3 ADHD domains: inattention (items 1-9); hyperactivity (items 10-16); impulsivity (items 17-20).
Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much).
The total score was calculated for ADHD overall (sum of ratings for items 1-20, divided by 20).
Higher scores indicate higher severity of symptoms.
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9 weeks
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Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity
Time Frame: 9 weeks
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FBB-SSV ("Fremdbeurteilungsbogen fur Storungen des Sozialverhaltens"), the German, parent-rated oppositional defiant/conduct disorders scale, covers 23 criteria for ODD and 25 for conduct disorder (CD) in four sections.
Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much).
The total score was calculated for ODD/CD overall (sum of ratings for items 1-17, divided by 17).
Higher scores indicate higher severity of symptoms.
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9 weeks
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Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score
Time Frame: 9 weeks
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ITB-Inv assesses frequency and intensity of individually-defined target behaviors.
The investigator defines 3 individual behavior problems based on interviews and additional information.
Those most impairing for the child or stressful for the parents will be chosen as target behavior.
Intensity during the last 7 days is rated on a 10-point scale (0=no problems to 9=most severe problems) with the lowest possible score of 0 and the highest possible of 27.
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9 weeks
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Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score
Time Frame: 9 weeks
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ITB-Inv assesses frequency and intensity of individually-defined target behaviors.
The investigator defines 3 individual behavior problems based on interviews and additional information.
Those most impairing for the child or stressful for the parents will be chosen as target behavior.
Frequency of each target behavior during the last 7 days is rated on a 6-point scale (0=never to 5=always) with 0 as lowest possible score and 15 the highest possible score.
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9 weeks
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Impact on Family Scale (FaBel), Total Impact Score
Time Frame: 9 weeks
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Family burden is assessed by the FaBel questionnaire (German version of the Impact on Family Scale).
Questionnaire is answered by participant's caregiver and contains 33 Likert-scaled items to assess general negative impact (of a disability, disorder, disease) on parents, description of social relationships, concern for siblings, financial impact, problems in coping as well as a total score.
Each item is rated on a 4-point scale (1=fully applies, 4=applies not at all).
Total scores range from 24-96.
Higher scores correspond to higher family burden.
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9 weeks
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Clinical Global Impressions - Severity (CGI-S): ADHD Score
Time Frame: 9 weeks
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The physician-rated CGI-S ADHD measures the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.
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9 weeks
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Clinical Global Impressions - Severity (CGI-S): ODD Score
Time Frame: 9 weeks
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The physician-rated CGI-S ODD measures the participant's overall severity of ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.
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9 weeks
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Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores
Time Frame: 9 weeks
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The physician-rated CGI-S Combined ADHD and ODD measures the participant's overall severity of both ADHD and ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.
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9 weeks
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German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score
Time Frame: 9 weeks
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KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL.
It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness.
Each item is rated on a 5-point scale (1= never; 5= all the time).
The lowest possible score in the Total QOL score is 0; the highest possible score is 100.
Scores were normalized between 0 and 100, irrespective of the number of items per subscore.
Higher score indicates better QOL.
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9 weeks
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German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score
Time Frame: 9 weeks
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KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL.
It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness.
Each item is rated on a 5-point scale (1= never; 5= all the time).
The lowest possible score on the Physical Well-Being subscale is 0; highest possible score is 100.
Scores were normalized between 0 and 100, irrespective of the number of items per subscore.
Higher scores indicate better QOL.
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9 weeks
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German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score
Time Frame: 9 weeks
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KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL.
It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness.
Each item is rated on a 5-point scale (1= never; 5= all the time).The lowest possible score for the Emotional Well-Being subscale is 0; highest possible score is 100.
Scores were normalized between 0 and 100, irrespective of the number of items per subscore.
Higher scores indicate better QOL.
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9 weeks
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German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score
Time Frame: 9 weeks
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KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL.
It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness.
Each item is rated on a 5-point scale (1= never; 5= all the time).
The lowest possible score on the Self Esteem subscale is 0; the highest possible score is 100.
Scores were normalized between 0 and 100, irrespective of the number of items per subscore.
Higher scores indicate better QOL.
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9 weeks
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German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score
Time Frame: 9 weeks
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KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL.
It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness.
Each item is rated on a 5-point scale (1=never; 5=all the time).
The lowest possible score on the Family subscale is 0; the highest possible score is 100.
Scores were normalized between 0 and 100, irrespective of the number of items per subscore.
Higher scores indicate better QOL.
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9 weeks
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German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score
Time Frame: 9 weeks
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KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL.
It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness.
Each item is rated on a 5-point scale (1= never; 5= all the time).
The lowest possible score on the Friends subscale is 0; the highest possible score is 100.
Scores were normalized between 0 and 100, irrespective of the number of items per subscore.
Higher scores indicate better QOL.
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9 weeks
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German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score
Time Frame: 9 weeks
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KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL.
It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness.
Each item is rated on a 5-point scale (1= never; 5= all the time).
The lowest possible score on the School subscore is 0; the highest possible score is 100.
Scores were normalized between 0 and 100, irrespective of the number of items per subscore.
Higher scores indicate better QOL.
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9 weeks
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Number of Participants Discontinuing Treatment
Time Frame: 9 weeks
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Originally, time to treatment discontinuation was analyzed, deeming participants 'censored' if they reached the end of the observation period, were lost to followup, or withdrew informed consent.
Because the median was not reached, the number of participants who discontinued (i.e., those who were not censored) is reported here.
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9 weeks
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Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment
Time Frame: 3 weeks
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Number of participants who experienced pre-specified categories of clinically relevant adverse events during the initial three-weeks of study treatment.
NOTE: this is a subset of the overall adverse events which are reported by participant and event.
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3 weeks
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Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period
Time Frame: 9 weeks
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Number of participants who experienced pre-specified categories of clinically relevant adverse events during the nine-week study treatment period.
NOTE: this is a subset of the overall adverse events which are reported by participant and event.
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9 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
November 29, 2006
First Submitted That Met QC Criteria
November 29, 2006
First Posted (Estimate)
December 4, 2006
Study Record Updates
Last Update Posted (Estimate)
February 26, 2010
Last Update Submitted That Met QC Criteria
February 19, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Neurodevelopmental Disorders
- Disease
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Attention Deficit and Disruptive Behavior Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Adrenergic Uptake Inhibitors
- Atomoxetine Hydrochloride
Other Study ID Numbers
- 11149 (DAIDS ES Registry Number)
- B4Z-SB-LYDW (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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