Long-Term, Open Label Atomoxetine Study

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00190684

Collaborator

(none)

1,553

Enrollment

100

Locations

Arm

110

Duration (Months)

15.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Drug: atomoxetine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1553 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Long-Term, Open Label Safety Study of Atomoxetine Hydrochloride in Patients, 6 Years and Older With Attention-Deficit/Hyperactivity Disorder

Study Start Date :

Aug 1, 2000

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: atomoxetine 0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years Other Names: LY139603 Strattera

Arm

Intervention/Treatment

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.

Drug: atomoxetine

0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years

Other Names:

LY139603

Strattera

Outcome Measures

Primary Outcome Measures

Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study [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 [baseline, 5 years]
Change From Baseline to 5 Year Endpoint in Pulse [baseline, 5 years]
Change From Baseline to 5 Year Endpoint in Body Weight [baseline, 5 years]
Change From Baseline to 5 Year Endpoint in Height [baseline, 5 years]
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile [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) [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 [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) [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) [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 [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 [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: 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)

Secondary Outcome Measures

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 [baseline, 5 years]
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.
Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score [baseline, 5 years]
Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores [baseline, 5 years]
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.
Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test [baseline, 5 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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.	Birmingham	Alabama	United States	35233
2	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.	Phoenix	Arizona	United States	85016
3	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.	El Centro	California	United States	92243
4	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.	Irvine	California	United States	92618
5	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.	Lafayette	California	United States	94549
6	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.	Los Angeles	California	United States	90095
7	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.	San Diego	California	United States	92123
8	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.	Spring Valley	California	United States	91978
9	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.	Walnut Creek	California	United States	94596
10	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.	Norwich	Connecticut	United States	06360
11	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.	Boca Raton	Florida	United States	33433
12	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.	Gainsville	Florida	United States	32607
13	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.	Miami	Florida	United States	33173
14	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.	Orlando	Florida	United States	32806
15	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.	Tallahassee	Florida	United States	32308
16	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 Palm Beach	Florida	United States	33407
17	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.	Boise	Idaho	United States	83704
18	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.	Northbrook	Illinois	United States	60062
19	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.	Indianapolis	Indiana	United States	46202
20	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.	Lafayette	Indiana	United States	47904
21	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.	Iowa City	Iowa	United States	52242
22	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.	Bardstown	Kentucky	United States	40004
23	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.	Lexington	Kentucky	United States	40509
24	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.	New Orleans	Louisiana	United States	70112
25	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.	Baltimore	Maryland	United States	21287
26	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.	Cambridge	Massachusetts	United States	02138
27	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.	Worcester	Massachusetts	United States	01655
28	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.	Detroit	Michigan	United States	48201
29	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.	Kalamazoo	Michigan	United States	49008
30	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.	Troy	Michigan	United States	48085
31	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.	St. Louis	Missouri	United States	63141
32	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.	Omaha	Nebraska	United States	68198
33	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.	Cherry Hill	New Jersey	United States	08034
34	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.	Clementon	New Jersey	United States	08021
35	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.	Moorestown	New Jersey	United States	08057
36	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.	Piscataway	New Jersey	United States	08855
37	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.	Manhasset	New York	United States	11030
38	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.	New Hyde Park	New York	United States	11042
39	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.	New York	New York	United States	10016
40	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.	Rochester	New York	United States	14620
41	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.	Stony Brook	New York	United States	11794
42	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.	Chapel Hill	North Carolina	United States	27514
43	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.	Charlotte	North Carolina	United States	28211
44	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.	Durham	North Carolina	United States	27705
45	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.	Cincinnati	Ohio	United States	45267
46	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.	Cleveland	Ohio	United States	44195
47	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.	Columbus	Ohio	United States	43210
48	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.	Oklahoma City	Oklahoma	United States	73103
49	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.	Portland	Oregon	United States	97239
50	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.	Hershey	Pennsylvania	United States	17033
51	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.	Media	Pennsylvania	United States	19063
52	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.	Philadelphia	Pennsylvania	United States	19129
53	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.	Pittsburgh	Pennsylvania	United States	15241
54	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.	Rydal	Pennsylvania	United States	19046
55	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.	Providence	Rhode Island	United States	02903
56	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.	Nashville	Tennessee	United States	37212
57	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.	Dallas	Texas	United States	75235
58	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.	Galveston	Texas	United States	77555
59	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.	Lake Jackson	Texas	United States	77566
60	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.	Salt Lake City	Utah	United States	84107
61	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.	Fairfax	Virginia	United States	22031
62	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.	Herndon	Virginia	United States	20170
63	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.	Midlothian	Virginia	United States	23112
64	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.	Norfolk	Virginia	United States	23510
65	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.	Richmond	Virginia	United States	23298
66	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.	Vienna	Virginia	United States	22180
67	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.	Spokane	Washington	United States	99220
68	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.	Marshfield	Wisconsin	United States	54449
69	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.	Middleton	Wisconsin	United States	53562
70	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.	Milwaukee	Wisconsin	United States	53226
71	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	New South Wales	Australia	2287
72	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	Queensland	Australia	4101
73	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	Western Australia	Australia	6005
74	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.	Antwerpen		Belgium	2020
75	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.	Leuven		Belgium	3000
76	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.	Edmonton	Alberta	Canada	T5G0B7
77	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.	Halifax	Nova Scotia	Canada	B3J3G9
78	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.	Toronto	Ontario	Canada	M5G1X8
79	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.	Quebec City	Quebec	Canada	G1R2W8
80	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.	Bordeaux Cedex		France	33076
81	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.	Lyon		France	69395
82	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.	Paris Cedex 12		France	75571
83	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.	Paris		France	75019
84	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.	Heiligenstadt/Ofr		Germany	D-91332
85	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.	Mannheim		Germany	68159
86	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.	Holon		Israel	22100
87	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.	Ness Ziona		Israel	70450
88	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.	Cagliari		Italy	09124
89	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.	Pisa		Italy	50018
90	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.	Groningen		Netherlands	9713 GZ
91	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.	Utrecht		Netherlands	3584 CX
92	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		Norway	0319
93	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.	Rio Piedras		Puerto Rico	00936
94	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.	San Juan		Puerto Rico	00936
95	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.	Benmore	Sandown	South Africa	2010
96	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.	Garsfontein		South Africa	0042
97	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.	Panorama		South Africa	7500
98	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.	Goteburg		Sweden	41118
99	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.	Glasgow	Scotland	United Kingdom	G3 8SJ
100	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	United Kingdom	S10 5DD

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Lilly Clinical Trial Registry

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00190684

Other Study ID Numbers:

4331
B4Z-MC-LYAI

First Posted:

Sep 19, 2005

Last Update Posted:

Jan 17, 2011

Last Verified:

Dec 1, 2010

Additional relevant MeSH terms:

Hyperkinesis

Attention Deficit Disorder with Hyperactivity

Atomoxetine Hydrochloride

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Period Title: Overall Study
STARTED	1553
Received at Least 1 Dose of Study Drug	1551
COMPLETED	64
NOT COMPLETED	1489

Baseline Characteristics

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Overall Participants	1553
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.62 (2.6)
Sex: Female, Male (Count of Participants)
Female	338 21.8%
Male	1215 78.2%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	1317 84.8%
African Descent	98 6.3%
East/ Southeast Asian	9 0.6%
Western Asian	1 0.1%
Hispanic	76 4.9%
Other	52 3.3%
Region of Enrollment (participants) [Number]
United States	1288 82.9%
Israel	16 1%
United Kingdom	24 1.5%
Italy	11 0.7%
France	21 1.4%
Canada	14 0.9%
Puerto Rico	19 1.2%
Belgium	20 1.3%
Australia	22 1.4%
South Africa	19 1.2%
Germany	21 1.4%
Netherlands	15 1%
Norway	13 0.8%
Sweden	27 1.7%
Spain	23 1.5%
Height (centimeters (cm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters (cm)]	147.89 (15.72)
Weight (kilograms (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms (kg)]	43.73 (16.03)
Attention Deficit Hyperactive Disorder (ADHD) Subtype (participants) [Number]
Inattentive	413 26.6%
Hyperactive/Impulsive	46 3%
Combined	1016 65.4%
Not Applicable	72 4.6%
Unknown	6 0.4%

Outcome Measures

1. Primary Outcome

Title	Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
Description	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%.
Time Frame	Baseline through 5 years

Outcome Measure Data

Analysis Population Description
For each vital sign, the number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug. Number of subject analyzed for each vital sign is provided.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1528
Systolic BP High (N=1431)	228 14.7%
Diastolic BP High (N=1458)	92 5.9%
Pulse High (N=1528)	19 1.2%
Pulse Low (N=1528)	39 2.5%
Temperature High (N=1525)	7 0.5%
Temperature Low (N=1525)	9 0.6%
Weight Decrease (N=1526)	61 3.9%

2. Primary Outcome

Title	Change From Baseline to 5 Year Endpoint in BP
Description
Time Frame	baseline, 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1528
Systolic BP	4.7 (11.56)
Diastolic BP	1.3 (9.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for systolic BP
	Method	Wilcoxon signed-rank test
	Comments	Change = endpoint-baseline

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for diastolic BP
	Method	Wilcoxon sign-rank test
	Comments	Change = endpoint-baseline

3. Primary Outcome

Title	Change From Baseline to 5 Year Endpoint in Pulse
Description
Time Frame	baseline, 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1528
Mean (Standard Deviation) [beats per minute (bpm)]	-1.5 (13.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for pulse
	Method	Wilcoxon signed-rank test
	Comments

4. Primary Outcome

Title	Change From Baseline to 5 Year Endpoint in Body Weight
Description
Time Frame	baseline, 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1526
Mean (Standard Deviation) [kilograms (kg)]	11.0 (11.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for weight
	Method	Wilcoxon signed-rank test
	Comments

5. Primary Outcome

Title	Change From Baseline to 5 Year Endpoint in Height
Description
Time Frame	baseline, 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1476
Mean (Standard Deviation) [centimeters (cm)]	10.9 (10.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for height
	Method	Wilcoxon signed-rank test
	Comments

6. Primary Outcome

Title	Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
Description	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.
Time Frame	baseline, 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and 5 year endpoint measurement.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	251
Weight (0 to 25th percentile) (N=46)	18.93 (9.26)
Weight (25th to 50th percentile) (N=58)	14.90 (22.31)
Weight (50th to 75th percentile) (N=50)	-1.33 (20.21)
Weight (75th to 100th percentile) (N=97)	-6.68 (15.50)
Height (0 to 25th percentile) (N=64)	12.06 (21.00)
Height (25th tp 50th percentile) (N=61)	9.53 (21.76)
Height (50th to 75th percentile) (N=55)	-6.28 (22.55)
Height (75th to 100th percentile) (N=65)	-10.92 (20.31)
BMI (0 to 25th percentile) (N=34)	18.71 (24.76)
BMI (25th to 50th percentile) (N=53)	8.52 (28.11)
BMI (50th to 75th percentile) (N=55)	-3.26 (25.69)
BMI (75th to 100th percentile) (N=101)	-7.94 (18.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for weight 0 to 25th percentile
	Method	paired t-test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for weight 25th to 50th percentile
	Method	paired t-test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.644
	Comments	p-value is for weight 50th to 75th percentile
	Method	paired t-test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for weight 75th to 100th percentile
	Method	paired t-test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for height 0 to 25th percentile
	Method	paired t-test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments	p-value is for height 25th to 50th percentile
	Method	paired t-test
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.044
	Comments	p-value is for height 50th to 75th percentile
	Method	paired t-test
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for height 75th to 100th percentile
	Method	paired t-test
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for BMI 0 to 25th percentile
	Method	paired t-test
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.032
	Comments	p-value is for BMI 25th to 50th percentile
	Method	paired t-test
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.351
	Comments	p-value is for BMI 50th to 75th percentile
	Method	paired t-test
	Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for BMI 75th to 100th percentile
	Method	paired t-test
	Comments

7. Primary Outcome

Title	Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
Description	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.
Time Frame	baseline, 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1482
RR Interval	27.2 (138.78)
QRS Interval	2.6 (7.19)
QT Bazett (bz) Correction	-1.7 (17.85)
QT Data (dat) Correction	-0.2 (15.43)
QT Fridericia (fr) Correction	0.5 (15.71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for RR interval
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for QRS Interval
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for QT Bazett Correction
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.310
	Comments	p-value is for QT Data Correction
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.632
	Comments	p-value is for QT Fridericia Correction
	Method	Wilcoxon signed-rank test
	Comments

8. Primary Outcome

Title	Change From Baseline to 5 Year Endpoint in Heart Rate
Description	Patients were assessed for changes in heart rate using electrocardiogram.
Time Frame	baseline, 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1482
Mean (Standard Deviation) [beats per minute (bpm)]	-2.5 (14.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for HR.
	Method	Wilcoxon signed-rank test
	Comments

9. Primary Outcome

Title	Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
Description	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.
Time Frame	baseline through 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1482
QTc (bz) Increase of at least 30 milliseconds (ms)	68 4.4%
QTc (bz) Increase of at least 60 ms	2 0.1%
QTc (bz) Increase to values >500 ms	0 0%
QTc (dat) Increase of at least 30 ms	50 3.2%
QTc (dat) Increase of at least 60 ms	2 0.1%
QTc (dat) Increase to values >500 ms	0 0%
QTc (fr) Increase of at least 30 ms	56 3.6%
QTc (fr) Increase of at least 60 ms	2 0.1%
QTc (fr) Increase to values >500 ms	0 0%

10. Secondary Outcome

Title	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
Description	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.
Time Frame	baseline, 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1135
Total Score	3.5 (9.62)
Inattentive Subscale Score	2.6 (6.00)
Hyperactive Subscale Score	0.9 (4.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	p<0.001
	Comments	p-value is for Total Score
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for Inattentive Subscale Score
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	p<0.001
	Comments	p-value is for Hyperactive Subscale Score
	Method	Wilcoxon signed-rank test
	Comments

11. Secondary Outcome

Title	Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score
Description	Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Time Frame	baseline, 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1136
Mean (Standard Deviation) [units on a scale]	0.523 (1.149)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for CGI ADHD Severity within group
	Method	Wilcoxon signed-rank test
	Comments	This test is for a significance of a location shift from zero of the change from baseline within a treatment group.

12. Secondary Outcome

Title	Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores
Description	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.
Time Frame	baseline, 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1059
CPRS ADHD Index Subscale (n=1056)	2.411 (7.785)
CPRS Cognitive Subscale (n=1056)	1.500 (4.777)
CPRS Hyperactive Subscale (n=1057)	0.325 (3.287)
CPRS Oppositional Subscale (n=1059)	1.357 (4.287)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for CPRS ADHD Index Subscale within group
	Method	Wilcoxon signed-rank test
	Comments	This test is for a significance of a location shift from zero of the change from baseline within a treatment group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	p<0.001
	Comments	p-value is for CPRS Cognitive Subscale
	Method	Wilcoxon signed-rank test
	Comments	This test is for a significance of a location shift from zero of the change from baseline within a treatment group.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.026
	Comments	p-value is for CPRS Hyperactive Subscale
	Method	Wilcoxon signed-rank test
	Comments	This test is for a significance of a location shift from zero of the change from baseline within a treatment group.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Atomoxetine
	Comments	Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for CPRS Oppositional Subscale
	Method	Wilcoxon signed-rank test
	Comments	This test is for a significance of a location shift from zero of the change from baseline within a treatment group.

13. Secondary Outcome

Title	Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test
Description	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.
Time Frame	baseline, 5 years

Outcome Measure Data

Analysis Population Description
There were not enough participants with prior Stroop Word Color tests to analyze the data.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	0

14. Primary Outcome

Title	Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
Description	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.
Time Frame	baseline through 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1482
QTc (bz) Normal Baseline/Normal Endpoint	1069 68.8%
QTc (bz) Normal Baseline/Borderline Endpoint	156 10%
QTc (bz) Normal Baseline/Prolonged Endpoint	11 0.7%
QTc (bz) Borderline Baseline/Normal Endpoint	180 11.6%
QTc (bz) Borderline Baseline/Borderline Endpoint	49 3.2%
QTc (bz) Borderline Baseline/Prolonged Endpoint	6 0.4%
QTc (bz) Prolonged Baseline/Normal Endpoint	6 0.4%
QTc (bz) Prolonged Baseline/Borderline Endpoint	5 0.3%
QTc (bz) Prolonged Baseline/Prolonged Endpoint	0 0%
QTc (dat) Normal Baseline/Normal Endpoint	1433 92.3%
QTc (dat) Normal Baseline/Borderline Endpoint	26 1.7%
QTc (dat) Normal Baseline/Prolonged Endpoint	1 0.1%
QTc (dat) Borderline Baseline/Normal Endpoint	16 1%
QTc (dat) Borderline Baseline/Borderline Endpoint	3 0.2%
QTc (dat) Borderline Baseline/Prolonged Endpoint	1 0.1%
QTc (dat) Prolonged Baseline/Normal Endpoint	2 0.1%
QTc (dat) Prolonged Baseline/Borderline Endpoint	0 0%
QTc (dat) Prolonged Baseline/Prolonged Endpoint	0 0%
QTc (fr) Normal Baseline/Normal Endpoint	1454 93.6%
QTc (fr) Normal Baseline/Borderline Endpoint	16 1%
QTc (fr) Normal Baseline/Prolonged Endpoint	2 0.1%
QTc (fr) Borderline Baseline/Normal Endpoint	7 0.5%
QTc (fr) Borderline Baseline/Borderline Endpoint	0 0%
QTc (fr) Borderline Baseline/Prolonged Endpoint	1 0.1%
QTc (fr) Prolonged Baseline/Normal Endpoint	2 0.1%
QTc (fr) Prolonged Baseline/Borderline Endpoint	0 0%
QTc (fr) Prolonged Baseline/Prolonged Endpoint	0 0%

15. Primary Outcome

Title	Number of Participants With Abnormal Laboratory Analytes During the Study
Description	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)
Time Frame	baseline through 5 years

Outcome Measure Data

Analysis Population Description
The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	1487
AST/SGOT (U/L) Low (N=1484)	0 0%
AST/SGOT (U/L) High (N=1484)	27 1.7%
ALT/SGPT (U/L) Low (N=1486)	2 0.1%
ALT/SGPT (U/L) High (N=1486)	38 2.4%
Creatine Phosphokinase (U/L) Low (N=1485)	0 0%
Creatine Phosphokinase (U/L) High (N=1485)	57 3.7%
Alkaline Phosphatase (U/L) Low (N=1486)	67 4.3%
Alkaline Phosphatase (U/L) High (N=1486)	83 5.3%
Gamma Glutamyltransferase (U/L) Low (N=1486)	0 0%
Gamma Glutamyltransferase (U/L) High (N=1486)	17 1.1%
Urea Nitrogen (mmol/L) Low (N=1487)	1 0.1%
Urea Nitrogen (mmol/L) High (N=1487)	2 0.1%
Calcium (mmol/L) Low (N=1487)	0 0%
Calcium (mmol/L) High (N=1487)	117 7.5%
Inorganic Phosphorus (mmol/L) Low (N=1485)	10 0.6%
Inorganic Phosphorus (mmol/L) High (N=1485)	31 2%
Total Protein (g/L) Low (N=1487)	2 0.1%
Total Protein (g/L) High (N=1487)	5 0.3%
Albumin (g/L) Low (N=1487)	1 0.1%
Albumin (g/L) High (N=1487)	113 7.3%
Glucose, Non-Fasting/Random (mmol/L) Low (N=1486)	20 1.3%
Glucose, Non-Fasting/Random (mmol/L) High (N=1486)	1 0.1%
Uric Acid (umol/L) Low (N=1487)	6 0.4%
Uric Acid (umol/L) High (N=1487)	130 8.4%
Cholesterol (mmol/L) Low (N=1487)	87 5.6%
Cholesterol (mmol/L) High (N=1487)	72 4.6%
Creatinine (umol/L) Low (N=1487)	0 0%
Creatinine (umol/L) High (N=1487)	285 18.4%
Total Bilirubin (umol/L) Low (N=1458)	0 0%
Total Bilirubin (umol/L) High (N=1458)	38 2.4%
Hematocrit (1) Low (N=1482)	24 1.5%
Hematocrit (1) High (N=1482)	85 5.5%
Hemoglobin (mmL/L-Fe) Low (N=1482)	14 0.9%
Hemoglobin (mmL/L-Fe) High (N=1482)	30 1.9%
Erythrocyte Count (TI/L) Low (N=1482)	8 0.5%
Erythrocyte Count (TI/L) High (N=1482)	3 0.2%
Leukocyte Count (GI/L) Low (N=1482)	63 4.1%
Leukocyte Count (GI/L) High (N=1482)	8 0.5%
Bands (GI/L) Low (N=1482)	0 0%
Bands (GI/L) High (N=1482)	0 0%
Neutrophils, Segmented (GI/L) Low (N=1482)	20 1.3%
Neutrophils, Segmented (GI/L) High (N=1482)	23 1.5%
Lymphocytes (GI/L) Low (N=1482)	6 0.4%
Lymphocytes (GI/L) High (N=1482)	0 0%
Monocytes (GI/L) Low (N=1482)	62 4%
Monocytes (GI/L) High (N=1482)	12 0.8%
Eosinophils (GI/L) Low (N=1482)	0 0%
Eosinophils (GI/L) High (N=1482)	54 3.5%
Basophils (GI/L) Low (N=1482)	0 0%
Basophils (GI/L) High (N=1482)	3 0.2%
Mean Cell Volume (fL) Low (N=1482)	26 1.7%
Mean Cell Volume (fL) High (N=1482)	10 0.6%
Platelet Count (GI/L) Low (N=1479)	1 0.1%
Platelet Count (GI/L) High (N=1479)	63 4.1%
Sodium (mmol/L) Low (N=1486)	0 0%
Sodium (mmol/L) High (N=1486)	2 0.1%
Potassium (mmol/L) Low (N=1484)	0 0%
Potassium (mmol/L) High (N=1484)	8 0.5%
Chloride (mmol/L) Low (N=1486)	0 0%
Chloride (mmol/L) High (N=1486)	2 0.1%
Bicarbonate (mmol/L) Low (N=1486)	7 0.5%
Bicarbonate (mmol/L) High (N=1486)	6 0.4%
UA-Specific Gravity (no units) Low (N=1486)	39 2.5%
UA-Specific Gravity (no units) High (N=1486)	73 4.7%
Lymphocytes, Atypical (GI/L) Low (N=52)	0 0%
Lymphocytes, Atypical (GI/L) High (N=52)	52 3.3%

16. Primary Outcome

Title	Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Description	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)
Time Frame	1 year through 5 years

Outcome Measure Data

Analysis Population Description
The analysis population is defined as patients with at least two Tanner measurements.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Measure Participants	93
First Tanner, Age Group 1, Tanner I (N=7)	2 0.1%
First Tanner, Age Group 1, Tanner II (N=7)	2 0.1%
First Tanner, Age Group 1, Tanner III (N=7)	2 0.1%
First Tanner, Age Group 1, Tanner IV (N=7)	1 0.1%
First Tanner, Age Group 1, Tanner V (N=7)	0 0%
First Tanner, Age Group 2, Tanner I (N=14)	4 0.3%
First Tanner, Age Group 2, Tanner II (N=14)	6 0.4%
First Tanner, Age Group 2, Tanner III (N=14)	2 0.1%
First Tanner, Age Group 2, Tanner IV (N=14)	2 0.1%
First Tanner, Age Group 2, Tanner V (N=14)	0 0%
First Tanner, Age Group 3, Tanner I (N=37)	0 0%
First Tanner, Age Group 3, Tanner II (N=37)	2 0.1%
First Tanner, Age Group 3, Tanner III (N=37)	13 0.8%
First Tanner, Age Group 3, Tanner IV (N=37)	15 1%
First Tanner, Age Group 3, Tanner V (N=37)	7 0.5%
First Tanner, Age Group 4, Tanner I (N=35)	0 0%
First Tanner, Age Group 4, Tanner II (N=35)	0 0%
First Tanner, Age Group 4, Tanner III (N=35)	2 0.1%
First Tanner, Age Group 4, Tanner IV (N=35)	11 0.7%
First Tanner, Age Group 4, Tanner V (N=35)	22 1.4%
Endpoint Tanner, Age Group 1, Tanner I (N=2)	1 0.1%
Endpoint Tanner, Age Group 1, Tanner II (N=2)	1 0.1%
Endpoint Tanner, Age Group 1, Tanner III (N=2)	0 0%
Endpoint Tanner, Age Group 1, Tanner IV (N=2)	0 0%
Endpoint Tanner, Age Group 1, Tanner V (N=2)	0 0%
Endpoint Tanner, Age Group 2, Tanner I (N=4)	0 0%
Endpoint Tanner, Age Group 2, Tanner II (N=4)	1 0.1%
Endpoint Tanner, Age Group 2, Tanner III (N=4)	2 0.1%
Endpoint Tanner, Age Group 2, Tanner IV (N=4)	1 0.1%
Endpoint Tanner, Age Group 2, Tanner V (N=4)	0 0%
Endpoint Tanner, Age Group 3, Tanner I (N=32)	0 0%
Endpoint Tanner, Age Group 3, Tanner II (N=32)	5 0.3%
Endpoint Tanner, Age Group 3, Tanner III (N=32)	8 0.5%
Endpoint Tanner, Age Group 3, Tanner IV (N=32)	14 0.9%
Endpoint Tanner, Age Group 3, Tanner V (N=32)	5 0.3%
Endpoint Tanner, Age Group 4, Tanner I (N=55)	0 0%
Endpoint Tanner, Age Group 4, Tanner II (N=55)	0 0%
Endpoint Tanner, Age Group 4, Tanner III (N=55)	3 0.2%
Endpoint Tanner, Age Group 4, Tanner IV (N=55)	19 1.2%
Endpoint Tanner, Age Group 4, Tanner V (N=55)	33 2.1%

Adverse Events

	Atomoxetine
Time Frame
Adverse Event Reporting Description

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Atomoxetine
	Affected / at Risk (%)	# Events
Total	92/1551 (5.9%)
Blood and lymphatic system disorders
Anaemia	1/1551 (0.1%)	1
Cardiac disorders
Pericarditis	1/1551 (0.1%)	1
Wolff-Parkinson-White syndrome	1/1551 (0.1%)	1
Ear and labyrinth disorders
Hearing impaired	1/1551 (0.1%)	1
Endocrine disorders
Hyperthyroidism	1/1551 (0.1%)	1
Eye disorders
Visual disturbance	1/1551 (0.1%)	1
Gastrointestinal disorders
Abdominal pain	3/1551 (0.2%)	3
Abdominal pain upper	1/1551 (0.1%)	1
Inguinal hernia	1/1551 (0.1%)	1
Nausea	1/1551 (0.1%)	1
Vomiting	1/1551 (0.1%)	1
General disorders
Pain	1/1551 (0.1%)	1
Pyrexia	1/1551 (0.1%)	1
Infections and infestations
Appendicitis	10/1551 (0.6%)	10
Campylobacter infection	1/1551 (0.1%)	1
Cellulitis	1/1551 (0.1%)	1
Dengue fever	1/1551 (0.1%)	1
Enterocolitis infectious	1/1551 (0.1%)	1
Gastroenteritis	3/1551 (0.2%)	4
Gastroenteritis viral	1/1551 (0.1%)	1
Meningitis viral	1/1551 (0.1%)	1
Oral candidiasis	1/1551 (0.1%)	1
Osteomyelitis	1/1551 (0.1%)	1
Otitis media	1/1551 (0.1%)	1
Perianal abscess	1/1551 (0.1%)	1
Periorbital cellulitis	1/1551 (0.1%)	1
Pneumonia	4/1551 (0.3%)	5
Sinusitis	2/1551 (0.1%)	2
Staphylococcal infection	1/1551 (0.1%)	1
Viral infection	2/1551 (0.1%)	3
Injury, poisoning and procedural complications
Ankle fracture	1/1551 (0.1%)	1
Burns first degree	1/1551 (0.1%)	1
Burns second degree	1/1551 (0.1%)	1
Clavicle fracture	1/1551 (0.1%)	1
Concussion	4/1551 (0.3%)	4
Excoriation	1/1551 (0.1%)	1
Fall	2/1551 (0.1%)	2
Femur fracture	2/1551 (0.1%)	2
Foot fracture	1/1551 (0.1%)	1
Head injury	1/1551 (0.1%)	1
Humerus fracture	1/1551 (0.1%)	1
Intentional overdose	1/1551 (0.1%)	1
Ligament rupture	1/1551 (0.1%)	1
Multiple fractures	1/1551 (0.1%)	1
Multiple injuries	1/1551 (0.1%)	1
Overdose	1/1551 (0.1%)	1
Post concussion syndrome	1/1551 (0.1%)	1
Post procedural haemorrhage	1/1551 (0.1%)	1
Road traffic accident	4/1551 (0.3%)	4
Skull fracture	1/1551 (0.1%)	1
Subdural haematoma	2/1551 (0.1%)	2
Thermal burn	1/1551 (0.1%)	1
Tibia fracture	2/1551 (0.1%)	2
Wrist fracture	2/1551 (0.1%)	2
Investigations
Alanine aminotransferase increased	1/1551 (0.1%)	1
Aspartate aminotransferase increased	1/1551 (0.1%)	1
Blood glucose decreased	1/1551 (0.1%)	1
Blood glucose increased	1/1551 (0.1%)	5
Blood pressure decreased	1/1551 (0.1%)	1
Gamma-glutamyltransferase increased	1/1551 (0.1%)	1
Weight decreased	2/1551 (0.1%)	2
Metabolism and nutrition disorders
Dehydration	3/1551 (0.2%)	3
Diabetes mellitus	1/1551 (0.1%)	1
Diabetic ketoacidosis	1/1551 (0.1%)	1
Hyperglycaemia	1/1551 (0.1%)	1
Hypoglycaemia	1/1551 (0.1%)	1
Ketoacidosis	1/1551 (0.1%)	10
Type 1 diabetes mellitus	2/1551 (0.1%)	2
Musculoskeletal and connective tissue disorders
Bone cyst	1/1551 (0.1%)	1
Pathological fracture	1/1551 (0.1%)	1
Retrognathia	1/1551 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma	1/1551 (0.1%)	1
Nervous system disorders
Cerebral haemorrhage	1/1551 (0.1%)	1
Complex partial seizures	1/1551 (0.1%)	1
Depressed level of consciousness	1/1551 (0.1%)	1
Migraine	2/1551 (0.1%)	2
Migraine with aura	1/1551 (0.1%)	1
Psychomotor hyperactivity	1/1551 (0.1%)	1
Psychiatric disorders
Affect lability	1/1551 (0.1%)	1
Aggression	3/1551 (0.2%)	5
Agitation	1/1551 (0.1%)	1
Conduct disorder	1/1551 (0.1%)	1
Confusional state	1/1551 (0.1%)	1
Depression	5/1551 (0.3%)	5
Impulsive behaviour	1/1551 (0.1%)	1
Major depression	2/1551 (0.1%)	2
Mental status changes	1/1551 (0.1%)	1
Mood altered	1/1551 (0.1%)	1
Negativism	1/1551 (0.1%)	1
Oppositional defiant disorder	1/1551 (0.1%)	2
Post-traumatic stress disorder	1/1551 (0.1%)	1
Psychotic disorder	1/1551 (0.1%)	1
Pyromania	1/1551 (0.1%)	1
Substance abuse	1/1551 (0.1%)	1
Suicidal behaviour	1/1551 (0.1%)	1
Suicidal ideation	9/1551 (0.6%)	9
Suicide attempt	2/1551 (0.1%)	2
Respiratory, thoracic and mediastinal disorders
Asthma	2/1551 (0.1%)	3
Epistaxis	1/1551 (0.1%)	1
Surgical and medical procedures
Facial operation	1/1551 (0.1%)	1
Nasal septal operation	1/1551 (0.1%)	1
Vascular disorders
Haematoma	1/1551 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Atomoxetine
	Affected / at Risk (%)	# Events
Total	1372/1551 (88.5%)
Gastrointestinal disorders
Abdominal pain	82/1551 (5.3%)	100
Abdominal pain upper	260/1551 (16.8%)	353
Diarrhoea	125/1551 (8.1%)	166
Nausea	210/1551 (13.5%)	285
Vomiting	285/1551 (18.4%)	451
General disorders
Fatigue	147/1551 (9.5%)	186
Irritability	151/1551 (9.7%)	168
Pyrexia	248/1551 (16%)	386
Immune system disorders
Seasonal allergy	89/1551 (5.7%)	98
Infections and infestations
Ear infection	79/1551 (5.1%)	108
Gastroenteritis viral	122/1551 (7.9%)	152
Influenza	205/1551 (13.2%)	287
Nasopharyngitis	315/1551 (20.3%)	515
Pharyngitis streptococcal	129/1551 (8.3%)	177
Sinusitis	125/1551 (8.1%)	176
Upper respiratory tract infection	263/1551 (17%)	430
Viral infection	78/1551 (5%)	106
Metabolism and nutrition disorders
Decreased appetite	163/1551 (10.5%)	178
Nervous system disorders
Dizziness	83/1551 (5.4%)	103
Headache	534/1551 (34.4%)	1063
Psychiatric disorders
Depression	81/1551 (5.2%)	84
Insomnia	106/1551 (6.8%)	120
Respiratory, thoracic and mediastinal disorders
Cough	297/1551 (19.1%)	445
Epistaxis	79/1551 (5.1%)	97
Nasal congestion	168/1551 (10.8%)	263
Pharyngolaryngeal pain	267/1551 (17.2%)	414
Skin and subcutaneous tissue disorders
Acne	105/1551 (6.8%)	110
Rash	80/1551 (5.2%)	90

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	Chief Medical Officer
Organization	Eli Lilly and Company
Phone	800-545-5979
Email

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00190684

Other Study ID Numbers:

4331
B4Z-MC-LYAI

First Posted:

Sep 19, 2005

Last Update Posted:

Jan 17, 2011

Last Verified:

Dec 1, 2010

Long-Term, Open Label Atomoxetine Study

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Statistical Analysis 4

Statistical Analysis 5

Statistical Analysis 6

Statistical Analysis 7

Statistical Analysis 8

Statistical Analysis 9

Statistical Analysis 10

Statistical Analysis 11

Statistical Analysis 12

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Statistical Analysis 4

Statistical Analysis 5

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Statistical Analysis 4

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact