Long-Term, Open Label Atomoxetine Study
NCT00190684, Phase 3, Completed, Eli Lilly and Company; results first posted 2011-01-17
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Long-Term, Open Label Atomoxetine Study | ClinicalTrials.gov |
| NCT number | NCT00190684 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 1,553 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Eli Lilly and Company | ClinicalTrials.gov |
| Conditions | Attention Deficit Hyperactivity Disorder | ClinicalTrials.gov |
| Interventions | atomoxetine | ClinicalTrials.gov |
| First posted | 2005-09-19 | ClinicalTrials.gov |
| Last updated | 2011-01-17 | ClinicalTrials.gov |
| Results first posted | 2011-01-17 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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%. | ClinicalTrials.gov |
| Primary | Change From Baseline to 5 Year Endpoint in BP | baseline, 5 years | ClinicalTrials.gov | |
| Primary | Change From Baseline to 5 Year Endpoint in Pulse | baseline, 5 years | ClinicalTrials.gov | |
| Primary | Change From Baseline to 5 Year Endpoint in Body Weight | baseline, 5 years | ClinicalTrials.gov | |
| Primary | Change From Baseline to 5 Year Endpoint in Height | baseline, 5 years | ClinicalTrials.gov | |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | Change From Baseline to 5 Year Endpoint in Heart Rate | baseline, 5 years | Patients were assessed for changes in heart rate using electrocardiogram. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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) | ClinicalTrials.gov |
| Primary | 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: 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) | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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). | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
Outcomes 16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study | Baseline through 5 years | 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. | participants | NUMBER | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to 5 Year Endpoint in BP | baseline, 5 years | 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. | millimeters of Mercury (mmHg) | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to 5 Year Endpoint in Pulse | baseline, 5 years | 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. | beats per minute (bpm) | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to 5 Year Endpoint in Body Weight | baseline, 5 years | 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. | kilograms (kg) | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to 5 Year Endpoint in Height | baseline, 5 years | 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. | centimeters (cm) | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile | baseline, 5 years | The number of participants analyzed was defined as all patients with a baseline and 5 year endpoint measurement. | percentiles | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG) | baseline, 5 years | 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. | milliseconds (msec) | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to 5 Year Endpoint in Heart Rate | baseline, 5 years | 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. | beats per minute (bpm) | MEAN | ClinicalTrials.gov |
| PRIMARY | Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase) | baseline through 5 years | 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. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | 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 | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score | baseline, 5 years | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores | baseline, 5 years | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test | baseline, 5 years | There were not enough participants with prior Stroop Word Color tests to analyze the data. | number of correct answers | MEAN | ClinicalTrials.gov |
| PRIMARY | Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint) | baseline through 5 years | 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. | participants | NUMBER | ClinicalTrials.gov |
| PRIMARY | Number of Participants With Abnormal Laboratory Analytes During the Study | baseline through 5 years | 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. | participants | NUMBER | ClinicalTrials.gov |
| PRIMARY | Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group | 1 year through 5 years | The analysis population is defined as patients with at least two Tanner measurements. | participants | NUMBER | ClinicalTrials.gov |
Results by group 180
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study | Atomoxetine | Systolic BP High (N=1431) | 228 | participants | ClinicalTrials.gov | |
| Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study | Atomoxetine | Diastolic BP High (N=1458) | 92 | participants | ClinicalTrials.gov | |
| Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study | Atomoxetine | Pulse High (N=1528) | 19 | participants | ClinicalTrials.gov | |
| Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study | Atomoxetine | Pulse Low (N=1528) | 39 | participants | ClinicalTrials.gov | |
| Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study | Atomoxetine | Temperature High (N=1525) | 7 | participants | ClinicalTrials.gov | |
| Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study | Atomoxetine | Temperature Low (N=1525) | 9 | participants | ClinicalTrials.gov | |
| Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study | Atomoxetine | Weight Decrease (N=1526) | 61 | participants | ClinicalTrials.gov | |
| Change From Baseline to 5 Year Endpoint in BP | Atomoxetine | Systolic BP | 4.7 | Standard Deviation 11.56 | millimeters of Mercury (mmHg) | ClinicalTrials.gov |
| Change From Baseline to 5 Year Endpoint in BP | Atomoxetine | Diastolic BP | 1.3 | Standard Deviation 9.04 | millimeters of Mercury (mmHg) | ClinicalTrials.gov |
| Change From Baseline to 5 Year Endpoint in Pulse | Atomoxetine | -1.5 | Standard Deviation 13.83 | beats per minute (bpm) | ClinicalTrials.gov | |
| Change From Baseline to 5 Year Endpoint in Body Weight | Atomoxetine | 11.0 | Standard Deviation 11.66 | kilograms (kg) | ClinicalTrials.gov | |
| Change From Baseline to 5 Year Endpoint in Height | Atomoxetine | 10.9 | Standard Deviation 10.41 | centimeters (cm) | ClinicalTrials.gov | |
| Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile | Atomoxetine | Weight (0 to 25th percentile) (N=46) | 18.93 | Standard Deviation 9.26 | percentiles | ClinicalTrials.gov |
| Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile | Atomoxetine | Weight (25th to 50th percentile) (N=58) | 14.90 | Standard Deviation 22.31 | percentiles | ClinicalTrials.gov |
| Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile | Atomoxetine | Weight (50th to 75th percentile) (N=50) | -1.33 | Standard Deviation 20.21 | percentiles | ClinicalTrials.gov |
| Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile | Atomoxetine | Weight (75th to 100th percentile) (N=97) | -6.68 | Standard Deviation 15.50 | percentiles | ClinicalTrials.gov |
| Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile | Atomoxetine | Height (0 to 25th percentile) (N=64) | 12.06 | Standard Deviation 21.00 | percentiles | ClinicalTrials.gov |
| Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile | Atomoxetine | Height (25th tp 50th percentile) (N=61) | 9.53 | Standard Deviation 21.76 | percentiles | ClinicalTrials.gov |
| Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile | Atomoxetine | Height (50th to 75th percentile) (N=55) | -6.28 | Standard Deviation 22.55 | percentiles | ClinicalTrials.gov |
| Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile | Atomoxetine | Height (75th to 100th percentile) (N=65) | -10.92 | Standard Deviation 20.31 | percentiles | ClinicalTrials.gov |
Participant flow 4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Atomoxetine | 1,553 | ClinicalTrials.gov | |
| Overall Study | Received at Least 1 Dose of Study Drug | Atomoxetine | 1,551 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Atomoxetine | 64 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Atomoxetine | 1,489 | ClinicalTrials.gov |
Adverse events 130
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Atomoxetine | 82 | 1,551 | 100 | ClinicalTrials.gov |
| other | Abdominal pain upper | Gastrointestinal disorders | Atomoxetine | 260 | 1,551 | 353 | ClinicalTrials.gov |
| other | Diarrhoea | Gastrointestinal disorders | Atomoxetine | 125 | 1,551 | 166 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Atomoxetine | 210 | 1,551 | 285 | ClinicalTrials.gov |
| other | Vomiting | Gastrointestinal disorders | Atomoxetine | 285 | 1,551 | 451 | ClinicalTrials.gov |
| other | Fatigue | General disorders | Atomoxetine | 147 | 1,551 | 186 | ClinicalTrials.gov |
| other | Irritability | General disorders | Atomoxetine | 151 | 1,551 | 168 | ClinicalTrials.gov |
| other | Pyrexia | General disorders | Atomoxetine | 248 | 1,551 | 386 | ClinicalTrials.gov |
| other | Seasonal allergy | Immune system disorders | Atomoxetine | 89 | 1,551 | 98 | ClinicalTrials.gov |
| other | Ear infection | Infections and infestations | Atomoxetine | 79 | 1,551 | 108 | ClinicalTrials.gov |
| other | Gastroenteritis viral | Infections and infestations | Atomoxetine | 122 | 1,551 | 152 | ClinicalTrials.gov |
| other | Influenza | Infections and infestations | Atomoxetine | 205 | 1,551 | 287 | ClinicalTrials.gov |
| other | Nasopharyngitis | Infections and infestations | Atomoxetine | 315 | 1,551 | 515 | ClinicalTrials.gov |
| other | Pharyngitis streptococcal | Infections and infestations | Atomoxetine | 129 | 1,551 | 177 | ClinicalTrials.gov |
| other | Sinusitis | Infections and infestations | Atomoxetine | 125 | 1,551 | 176 | ClinicalTrials.gov |
| other | Upper respiratory tract infection | Infections and infestations | Atomoxetine | 263 | 1,551 | 430 | ClinicalTrials.gov |
| other | Viral infection | Infections and infestations | Atomoxetine | 78 | 1,551 | 106 | ClinicalTrials.gov |
| other | Decreased appetite | Metabolism and nutrition disorders | Atomoxetine | 163 | 1,551 | 178 | ClinicalTrials.gov |
| other | Dizziness | Nervous system disorders | Atomoxetine | 83 | 1,551 | 103 | ClinicalTrials.gov |
| other | Headache | Nervous system disorders | Atomoxetine | 534 | 1,551 | 1,063 | ClinicalTrials.gov |
Adverse event totals 3
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Atomoxetine | ClinicalTrials.gov | ||
| Total, other adverse events | Atomoxetine | 1,372 | 1,551 | ClinicalTrials.gov |
| Total, serious adverse events | Atomoxetine | 92 | 1,551 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 17242628 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)