Attention Deficit Hyperactivity DisorderPhase 3NCT00190684
Long-Term, Open Label Atomoxetine Study
A Phase 3 study testing atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 100 sites in 14 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,553 participants
- Where
- 100 sitesin 14 countries
- Study dates
- Aug 2000to Oct 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
100 sites in 14 countries.
100 sites in 14 countries
United States70 sites
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Baltimore, Maryland, 21287
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Bardstown, Kentucky, 40004
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Birmingham, Alabama, 35233
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Boca Raton, Florida, 33433
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Boise, Idaho, 83704
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Cambridge, Massachusetts, 02138
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Chapel Hill, North Carolina, 27514
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Charlotte, North Carolina, 28211
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Cherry Hill, New Jersey, 08034
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Cincinnati, Ohio, 45267
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Clementon, New Jersey, 08021
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Cleveland, Ohio, 44195
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Columbus, Ohio, 43210
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Dallas, Texas, 75235
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Detroit, Michigan, 48201
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Durham, North Carolina, 27705
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El Centro, California, 92243
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Fairfax, Virginia, 22031
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Gainsville, Florida, 32607
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Galveston, Texas, 77555
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Herndon, Virginia, 20170
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Hershey, Pennsylvania, 17033
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Indianapolis, Indiana, 46202
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Iowa City, Iowa, 52242
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Irvine, California, 92618
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Kalamazoo, Michigan, 49008
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Lafayette, California, 94549
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Lafayette, Indiana, 47904
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Lake Jackson, Texas, 77566
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Lexington, Kentucky, 40509
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Los Angeles, California, 90095
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Manhasset, New York, 11030
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Marshfield, Wisconsin, 54449
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Media, Pennsylvania, 19063
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Miami, Florida, 33173
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Middleton, Wisconsin, 53562
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Midlothian, Virginia, 23112
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Milwaukee, Wisconsin, 53226
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Moorestown, New Jersey, 08057
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Nashville, Tennessee, 37212
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New Hyde Park, New York, 11042
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New Orleans, Louisiana, 70112
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New York, New York, 10016
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Norfolk, Virginia, 23510
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Northbrook, Illinois, 60062
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Norwich, Connecticut, 06360
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Oklahoma City, Oklahoma, 73103
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Omaha, Nebraska, 68198
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Orlando, Florida, 32806
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Philadelphia, Pennsylvania, 19129
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Phoenix, Arizona, 85016
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Piscataway, New Jersey, 08855
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Pittsburgh, Pennsylvania, 15241
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Portland, Oregon, 97239
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Providence, Rhode Island, 02903
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Richmond, Virginia, 23298
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Rochester, New York, 14620
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Rydal, Pennsylvania, 19046
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Salt Lake City, Utah, 84107
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San Diego, California, 92123
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Spokane, Washington, 99220
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Spring Valley, California, 91978
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St Louis, Missouri, 63141
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Stony Brook, New York, 11794
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Tallahassee, Florida, 32308
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Troy, Michigan, 48085
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Vienna, Virginia, 22180
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Walnut Creek, California, 94596
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West Palm Beach, Florida, 33407
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Worcester, Massachusetts, 01655
Canada4 sites
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Edmonton, Alberta, T5G0B7
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Halifax, Nova Scotia, B3J3G9
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Québec, Quebec, G1R2W8
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Toronto, Ontario, M5G1X8
France4 sites
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Bordeaux, 33076
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Lyon, 69395
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Paris, 75019
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Paris, 75571
Australia3 sites
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South Brisbane, Queensland, 4101
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Wallsend, New South Wales, 2287
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West Perth, Western Australia, 6005
South Africa3 sites
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Benmore, Sandown, 2010
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Garsfontein, 0042
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Panorama, 7500
Belgium2 sites
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Antwerp, 2020
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Leuven, 3000
Germany2 sites
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Heiligenstadt/Ofr, D-91332
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Mannheim, 68159
Israel2 sites
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Holon, 22100
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Ness Ziona, 70450
Italy2 sites
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Cagliari, 09124
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Pisa, 50018
Netherlands2 sites
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Groningen, 9713 GZ
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Utrecht, 3584 CX
Puerto Rico2 sites
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Rio Piedras, 00936
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San Juan, 00936
United Kingdom2 sites
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Glasgow, Scotland, G3 8SJ
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.
Sheffield, South Yorkshire, S10 5DD
Norway1 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.
Oslo, 0319
Sweden1 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.
Gothenburg, 41118
About this study
Official title: Long-Term, Open Label Safety Study of Atomoxetine Hydrochloride in Patients, 6 Years and Older With Attention-Deficit/Hyperactivity Disorder
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- atomoxetine
- 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.
atomoxetineDrug
Also called LY139603, Strattera
0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine | Experimental | 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. Receives: Drug: atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
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%.
Measured: Baseline through 5 years
Change From Baseline to 5 Year Endpoint in BP
Measured: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Pulse
Measured: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Body Weight
Measured: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Height
Measured: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
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.
Measured: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
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.
Measured: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Heart Rate
Patients were assessed for changes in heart rate using electrocardiogram.
Measured: baseline, 5 years
Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
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.
Measured: baseline through 5 years
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
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.
Measured: baseline through 5 years
Number of Participants With Abnormal Laboratory Analytes During the Study
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)
Measured: baseline through 5 years
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
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)
Measured: 1 year through 5 years
Secondary outcomes (4)
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
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.
Measured: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score
Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Measured: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores
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.
Measured: baseline, 5 years
Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test
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.
Measured: baseline, 5 years
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 startAug 2000
- Primary completionOct 2009
- Study completionOct 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,553 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 1-317-619-4559 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
- NCT00190684
- Sponsor's protocol ID
- 4331
- Other IDs
- B4Z-MC-LYAI
- Status last verified
- Dec 2010
- First submitted
- 12 Sep 2005
- Last updated
- 17 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Michelson D, Read HA, Ruff DD, Witcher J, Zhang S, McCracken J. CYP2D6 and clinical response to atomoxetine in children and adolescents with ADHD. J Am Acad Child Adolesc Psychiatry. 2007 Feb;46(2):242-51. doi: 10.1097/01.chi.0000246056.83791.b6.
PubMed 17242628
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term, Open Label Safety Study of Atomoxetine Hydrochloride in Patients, 6 Years and Older With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00190684
- Acronym / sponsor ID
- 4331
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,553 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 17 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine | Experimental | Drug: atomoxetineAtomoxetine-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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| atomoxetineAlso: LY139603, Strattera0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years | Drug | Atomoxetine |
Primary outcome
Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
Time frame: Baseline through 5 years
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%.
Change From Baseline to 5 Year Endpoint in BP
Time frame: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Pulse
Time frame: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Body Weight
Time frame: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Height
Time frame: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
Time frame: baseline, 5 years
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.
Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
Time frame: baseline, 5 years
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.
Change From Baseline to 5 Year Endpoint in Heart Rate
Time frame: baseline, 5 years
Patients were assessed for changes in heart rate using electrocardiogram.
Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
Time frame: baseline through 5 years
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.
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
Time frame: baseline through 5 years
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.
Number of Participants With Abnormal Laboratory Analytes During the Study
Time frame: baseline through 5 years
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)
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Time frame: 1 year through 5 years
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: 1. age<11.0 (female) and age<12 (male) 2. 11=<age<12 (female) or 12<=age<13 (male) 3. 12=<age<15 (female) or 13=<age<15 (male) 4. age>=15 (female and male)
4 secondary outcomes
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
Time frame: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score
Time frame: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores
Time frame: baseline, 5 years
Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test
Time frame: baseline, 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 17242628Michelson D, Read HA, Ruff DD, Witcher J, Zhang S, McCracken J. CYP2D6 and clinical response to atomoxetine in children and adolescents with ADHD. J Am Acad Child Adolesc Psychiatry. 2007 Feb;46(2):242-51. doi: 10.1097/01.chi.0000246056.83791.b6.
- 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 1-317-619-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
100 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 100 sites in 14 countries.
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 3 inclusion and 4 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 17 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in United States, Canada, France, Australia, South Africa and 9 more countries. 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 17 Jan 2011). 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?
Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study (time frame: Baseline through 5 years). The study lists 12 primary outcomes in all. 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 NCT00190684, 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 17 Jan 2011.