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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00190684
Registration number
NCT00190684
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
17/01/2011
Titles & IDs
Public title
Long-Term, Open Label Atomoxetine Study
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Scientific title
Long-Term, Open Label Safety Study of Atomoxetine Hydrochloride in Patients, 6 Years and Older With Attention-Deficit/Hyperactivity Disorder
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Secondary ID [1]
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B4Z-MC-LYAI
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Secondary ID [2]
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4331
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder
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Condition category
Condition code
Neurological
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Other neurological disorders
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - atomoxetine
Experimental: Atomoxetine - Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted with be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Treatment: Drugs: atomoxetine
0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
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Assessment method [1]
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Vital signs were assesed categorically using the term high for BP, high and low for pulse and temperature, or decreased for weight. For BP, high was an increase to a value above the 95th percentile of the National Institute of Health (NIH) values. For pulse, high was an increase of at least 25 beats per minute to at least 110, and low was a decrease of at least 20 beats per minute to at most 65 beats per minute. For temperature, high was an increase of at least 1 to 37.7 and low was a decrease of at least 1.3 to at most 35.6. Decrease in weight was marked by a reduction of at least 3.5%.
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Timepoint [1]
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Baseline through 5 years
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Primary outcome [2]
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Change From Baseline to 5 Year Endpoint in BP
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Assessment method [2]
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Timepoint [2]
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baseline, 5 years
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Primary outcome [3]
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Change From Baseline to 5 Year Endpoint in Pulse
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Assessment method [3]
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Timepoint [3]
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baseline, 5 years
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Primary outcome [4]
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Change From Baseline to 5 Year Endpoint in Body Weight
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Assessment method [4]
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Timepoint [4]
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baseline, 5 years
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Primary outcome [5]
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Change From Baseline to 5 Year Endpoint in Height
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Assessment method [5]
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Timepoint [5]
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baseline, 5 years
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Primary outcome [6]
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Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
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Assessment method [6]
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Patients were assessed for changes in weight, height, and BMI. BMI is an estimate of body fat based on body weight divided by height squared.
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Timepoint [6]
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baseline, 5 years
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Primary outcome [7]
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Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
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Assessment method [7]
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Patients were assessed for changes in ECG. The RR interval is the time duration between two consecutive R waves of the ECG. The QRS interval is the beginning of Q to the end of the S wave. The QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula.QTdat is the QT interval using a data specific correction method for children.
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Timepoint [7]
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baseline, 5 years
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Primary outcome [8]
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Change From Baseline to 5 Year Endpoint in Heart Rate
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Assessment method [8]
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Patients were assessed for changes in heart rate using electrocardiogram.
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Timepoint [8]
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baseline, 5 years
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Primary outcome [9]
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Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
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Assessment method [9]
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QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children.
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Timepoint [9]
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baseline through 5 years
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Primary outcome [10]
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Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
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Assessment method [10]
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QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children. For Males: Normal is <430 ms, Borderline is >=430 ms and <450 ms, Prolonged is >=450 ms. For Females: Normal is <450 ms, Borderline is >=450 ms and <470 ms, Prolonged is >=470 ms.
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Timepoint [10]
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baseline through 5 years
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Primary outcome [11]
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Number of Participants With Abnormal Laboratory Analytes During the Study
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Assessment method [11]
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Standard reference ranges from Covance Laboratories were used in the determination of abnormal high and low values based on age and gender, where appropriate. Aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase (SGOT); units/liter (U/L); alanine aminotransferase (ALT); serum glutamic pyruvic transaminase (SGPT); millimoles/liter (mmol/L); grams/liter (g/L); micromoles/liter (umol/L); millimoles/liter-iron (mmol/L-Fe); trillion/liter (TI/L)or 10^12 units/liter; Giga/liter (GI/L)or 10^9 units/liter; femtoliters (fL); urinalysis (UA)
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Timepoint [11]
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baseline through 5 years
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Primary outcome [12]
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Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
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Assessment method [12]
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Tanner Stage:
I: no pubic hair at all (prepubertal Dominic state) II: small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females) III: hair becomes more coarse and curly, and begins to extend laterally IV: adult-like hair quality, extending across pubis but sparing medial thighs V: hair extends to medial surface of the thighs
Age Groups:
age<11.0 (female) and age<12 (male)
11=<age<12 (female) or 12<=age<13 (male)
12=<age<15 (female) or 13=<age<15 (male)
age>=15 (female and male)
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Timepoint [12]
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1 year through 5 years
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Secondary outcome [1]
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Change From Baseline to 5 Year Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and Subscale Scores
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Assessment method [1]
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Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Hyperactive/Impulsive and Inattention Subscales consisted of 9 items each, for total subscale score range of 0 to 27. ADHD Index Subscale consisted of 12 items, for total score range of 0 to 36.
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Timepoint [1]
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baseline, 5 years
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Secondary outcome [2]
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Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score
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Assessment method [2]
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Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
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Timepoint [2]
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baseline, 5 years
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Secondary outcome [3]
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Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores
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Assessment method [3]
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A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36.
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Timepoint [3]
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baseline, 5 years
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Secondary outcome [4]
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Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test
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Assessment method [4]
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Only patients who took the Stroop Color Word Test in a previous atomoxetine study were required to complete the Stroop in this study. Stroop measures inhibition of dominant response and interference control. Patients were given tasks of recognition (colors), reading (where a word represents a color), and interference (reading words written in different colors). There were 100 items for each of the three categories and if they made it through 100 words with time remaining, they would repeat the list. Only a small number of patients had Stroop tests in this study, so no analysis was done.
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Timepoint [4]
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baseline, 5 years
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Eligibility
Key inclusion criteria
- Must be at least 6 years old but less than 18 years old when enrolled in first
atomoxetine study
- Must meet the study criteria for ADHD
- Must be willing to have blood drawn and to complete other test required for this study
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Minimum age
6
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Maximum age
18
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- allergic to more than 1 kind of medicine or have had multiple bad reactions to any
drug
- taking certain medicines that could interact with atomoxetine
- plan to move too far away from a doctor participating in this study in the next 5
years
- current or past history of any of the following: alcohol or drug abuse within the past
3 months, bipolar I or II disorder, high blood pressure, organic brain disease or
seizures, psychosis, other disorders or conditions diagnosed by a doctor that might
make you unsuitable to participate in this study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2000
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2009
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Sample size
Target
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Accrual to date
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Final
1553
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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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. - Wallsend
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Recruitment hospital [2]
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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. - South Brisbane
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Recruitment hospital [3]
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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. - West Perth
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Recruitment postcode(s) [1]
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2287 - Wallsend
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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6005 - West Perth
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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Idaho
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United States of America
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Illinois
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United States of America
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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New York
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North Carolina
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Rhode Island
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Tennessee
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Texas
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Utah
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Washington
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Wisconsin
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Belgium
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Antwerpen
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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France
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Bordeaux Cedex
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France
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Lyon
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France
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Paris Cedex 12
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France
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Paris
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Germany
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Heiligenstadt/Ofr
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Germany
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Mannheim
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Israel
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Holon
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Israel
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Ness Ziona
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Italy
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Cagliari
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Italy
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Pisa
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Netherlands
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Groningen
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Netherlands
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Utrecht
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Norway
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Oslo
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Puerto Rico
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Rio Piedras
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Puerto Rico
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San Juan
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South Africa
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Sandown
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South Africa
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Garsfontein
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South Africa
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Panorama
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Sweden
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Goteburg
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United Kingdom
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Scotland
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United Kingdom
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South Yorkshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To learn about the safety and any side effects of atomoxetine when given to children and
adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children
and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for
about 5 years (long-term).
Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been
interrupted or, atomoxetine experienced on a known stable dose.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00190684
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-619-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00190684
Download to PDF