Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).
Interventions
DRUGAtomoxetine
Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. at least 18 years of age 2. meet Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID) diagnostic criteria for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during childhood 3. have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score of 4 (moderate symptoms) or greater
Exclusion criteria
1. Patients who meet DSM-IV diagnostic criteria for current major depression and also patients who have total score of more than 12 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at Visit 1 and Visit 2. Patients who have both a current or past history of major depression and have received any anti-depression drug therapy within 6 months of Visit 1. 2. Patients who meet DSM-IV diagnostic criteria for have a current anxiety disorder and also require anti-anxiety drug therapy except for those taking benzodiazepines analogues for anxiety which need to be limited. 3. Patients who have any history of bipolar disorder (DSM-IV) , any history of schizophrenia or any history of a psychotic disorder (DSM-IV) will be excluded from the study. 4. Patients who have been diagnosed (DSM-IV) with a pervasive developmental disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discontinuations Due to Adverse Events (AE) | Baseline to 8 Weeks | The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S) | Baseline and 8 Weeks | 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 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score | Baseline and 8 Weeks | Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Self Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. |
| Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) | Baseline and 8 Weeks | The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). |
| Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14) | Baseline and 8 Weeks | The HAMA-14 scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. |
| Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Baseline and 8 Weeks | This was a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A subject was given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test was scored on the number of correct answers. There were 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. |
| Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score | Baseline and 8 Weeks | Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. |
| Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | Baseline to 8 Weeks | Vital signs reported are Pulse (beats per minute \[bpm\]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg). |
| Significant Changes in Body Weight During the Study | Baseline to 8 Weeks | Potentially clinically significant weight loss was defined as any decrease of at least 7 percent (%). Potentially clinically significant weight gain was defined as any increase of at least 7%. |
| Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | Baseline to 8 Weeks | The Fridericia correction of the QT interval (QTcF) was used. |
| Cytochrome P450 2D6 (CYP2D6) Phenotype Status | 8 Weeks | CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizzer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer. |
| Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Baseline and 8 Weeks | SF-36 assesses quality of life (QoL) on 8 domains and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better QoL). Raw domain scores: general health=5-25; physical functioning=10-30; role-physical=4-20; role-emotional=3-15; social functioning=2-10; bodily pain=2-12; vitality=4-20; mental health=5-25. Using norm based scores, all domains, MCS and PCS scores have average score of 50 with standard deviation of 10. Norm-based score=Z-score\*10+50 in each subscale. Range cannot be specified in norm-based scores. |
Countries
China, South Korea, Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atomoxetine Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Entry Criteria Exclusion | 3 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Atomoxetine |
|---|---|
| Age Continuous | 28.24 years STANDARD_DEVIATION 9.02 |
| Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype Hyperactive/Impulsive | 2 participants |
| Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype Inattentive | 25 participants |
| Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype Mixed | 17 participants |
| Height | 168.98 centimeters (cm) STANDARD_DEVIATION 6.04 |
| Prior Stimulant Exposure No | 30 participants |
| Prior Stimulant Exposure Unknown | 1 participants |
| Prior Stimulant Exposure Yes | 13 participants |
| Race/Ethnicity East Asian | 44 participants |
| Region of Enrollment China | 15 participants |
| Region of Enrollment Korea, Republic of | 17 participants |
| Region of Enrollment Taiwan | 12 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 30 Participants |
| Weight | 64.53 kilograms (kg) STANDARD_DEVIATION 9.27 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 41 / 44 |
| serious Total, serious adverse events | 1 / 44 |
Outcome results
Primary
Discontinuations Due to Adverse Events (AE)
The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.
Time frame: Baseline to 8 Weeks
Population: Number of participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine | Discontinuations Due to Adverse Events (AE) | Participants with >=1 AE (Discontinuation) | 1 participants |
| Atomoxetine | Discontinuations Due to Adverse Events (AE) | Somnolence (Nervous System Disorder) | 1 participants |
Secondary
Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time frame: Baseline and 8 Weeks
Population: Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) | Baseline | 4.8 units on a scale | Standard Deviation 3.9 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) | Change from Baseline | -1.5 units on a scale | Standard Deviation 3.8 |
p-value: 0.013t-test, 2 sided
Secondary
Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S)
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 and 8 Weeks
Population: Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S) | Baseline | 4.8 units on a scale | Standard Deviation 0.8 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S) | Change from Baseline | -1.7 units on a scale | Standard Deviation 1.3 |
p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score
Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Self Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.
Time frame: Baseline and 8 Weeks
Population: Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score | Baseline | 30.6 units on a scale | Standard Deviation 9.7 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score | Change from Baseline | -12.1 units on a scale | Standard Deviation 10.2 |
p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score
Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.
Time frame: Baseline and 8 Weeks
Population: Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score | Baseline | 32.0 units on a scale | Standard Deviation 6.3 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score | Change from Baseline | -12.8 units on a scale | Standard Deviation 10.4 |
p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)
The HAMA-14 scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.
Time frame: Baseline and 8 Weeks
Population: Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14) | Baseline | 6.7 units on a scale | Standard Deviation 4.7 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14) | Change from Baseline | -2.0 units on a scale | Standard Deviation 4.4 |
p-value: 0.005t-test, 2 sided
Secondary
Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)
SF-36 assesses quality of life (QoL) on 8 domains and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better QoL). Raw domain scores: general health=5-25; physical functioning=10-30; role-physical=4-20; role-emotional=3-15; social functioning=2-10; bodily pain=2-12; vitality=4-20; mental health=5-25. Using norm based scores, all domains, MCS and PCS scores have average score of 50 with standard deviation of 10. Norm-based score=Z-score\*10+50 in each subscale. Range cannot be specified in norm-based scores.
Time frame: Baseline and 8 Weeks
Population: Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Physical Component Summary: Baseline | 46.77 T-Score | Standard Deviation 9.11 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Physical Component Summary: Change from Baseline | -0.38 T-Score | Standard Deviation 9.23 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Mental Component Summary: Baseline | 43.71 T-Score | Standard Deviation 6.93 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Mental Component Summary: Change from Baseline | 3.62 T-Score | Standard Deviation 5.36 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Physical Functioning: Baseline | 53.12 T-Score | Standard Deviation 6.79 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Physical Functioning: Change from Baseline | -3.02 T-Score | Standard Deviation 9.09 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Role-Physical: Baseline | 43.58 T-Score | Standard Deviation 11.36 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Role-Physical: Change from Baseline | 1.30 T-Score | Standard Deviation 10.94 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Bodily Pain: Baseline | 50.46 T-Score | Standard Deviation 10.71 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Bodily Pain: Change from Baseline | 1.32 T-Score | Standard Deviation 9.31 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | General Health Perception: Baseline | 47.81 T-Score | Standard Deviation 9.67 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | General Health Perception: Change from Baseline | 2.48 T-Score | Standard Deviation 9.17 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Vitality: Baseline | 43.73 T-Score | Standard Deviation 8.63 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Vitality: Change from Baseline | 2.78 T-Score | Standard Deviation 8.61 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Social Functioning: Baseline | 40.97 T-Score | Standard Deviation 11.36 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Social Functioning: Change from Baseline | 2.82 T-Score | Standard Deviation 10.39 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Role-Emotional: Baseline | 36.63 T-Score | Standard Deviation 11.59 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Role-Emotional: Change from Baseline | 5.46 T-Score | Standard Deviation 13.05 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Mental Health: Baseline | 40.38 T-Score | Standard Deviation 9.42 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Mental Health: Change from Baseline | 5.51 T-Score | Standard Deviation 8.04 |
p-value: 0.791t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.037t-test, 2 sided
p-value: 0.446t-test, 2 sided
p-value: 0.365t-test, 2 sided
p-value: 0.087t-test, 2 sided
p-value: 0.043t-test, 2 sided
p-value: 0.086t-test, 2 sided
p-value: 0.01t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to 8 Week Endpoint in Stroop Color Word Test
This was a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A subject was given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test was scored on the number of correct answers. There were 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list.
Time frame: Baseline and 8 Weeks
Population: Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Word Test: Baseline | 82.4 number of correct answers | Standard Deviation 16.6 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Word Test: Change from Baseline | 4.5 number of correct answers | Standard Deviation 9.9 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Color Test: Baseline | 68.7 number of correct answers | Standard Deviation 14.8 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Color Test: Change from Baseline | 4.8 number of correct answers | Standard Deviation 10.6 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Color-Word Test: Baseline | 49.0 number of correct answers | Standard Deviation 16.5 |
| Atomoxetine | Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Color-Word Test: Change from Baseline | 3.5 number of correct answers | Standard Deviation 15.4 |
p-value: 0.005t-test, 2 sided
p-value: 0.005t-test, 2 sided
p-value: 0.144t-test, 2 sided
Secondary
Cytochrome P450 2D6 (CYP2D6) Phenotype Status
CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizzer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.
Time frame: 8 Weeks
Population: Number of participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine | Cytochrome P450 2D6 (CYP2D6) Phenotype Status | Extensive Metabolizer | 44 participants |
| Atomoxetine | Cytochrome P450 2D6 (CYP2D6) Phenotype Status | Poor Metabolizer | 0 participants |
Secondary
Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion
The Fridericia correction of the QT interval (QTcF) was used.
Time frame: Baseline to 8 Weeks
Population: Number of participants with baseline and post-baseline values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | QTcF Interval of >450 milliseconds (msec) | 0 participants |
| Atomoxetine | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | QTcF Interval of >480 msec | 0 participants |
| Atomoxetine | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | QTcF Interval of >500 msec | 0 participants |
| Atomoxetine | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | QTcF Interval Increase from Baseline of ≥30 msec | 1 participants |
| Atomoxetine | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | QTcF Interval Increase from Baseline of ≥60 msec | 0 participants |
Secondary
Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study
Vital signs reported are Pulse (beats per minute \[bpm\]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).
Time frame: Baseline to 8 Weeks
Population: Number of participants with baseline and post-baseline values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | Low DBP (mmHg)=Decrease ≥15 to value of at most 50 | 0 participants |
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | High Pulse (bpm)=Increase ≥15 to a value >120 | 0 participants |
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | Low Pulse (bpm)=Decrease ≥15 to a value <50 | 0 participants |
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | High SBP (mmHg)=Increase ≥20 to a value >180 | 0 participants |
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | Low SBP (mmHg)=Decrease ≥20 to value of at most 90 | 1 participants |
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | High DBP (mmHg)=Increase ≥15 to value at least 105 | 0 participants |
Secondary
Significant Changes in Body Weight During the Study
Potentially clinically significant weight loss was defined as any decrease of at least 7 percent (%). Potentially clinically significant weight gain was defined as any increase of at least 7%.
Time frame: Baseline to 8 Weeks
Population: Number of participants with baseline and post-baseline values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine | Significant Changes in Body Weight During the Study | Weight Loss = Any Decrease of at Least 7% | 5 participants |
| Atomoxetine | Significant Changes in Body Weight During the Study | Weight Gain = Any Increase of at Least 7% | 0 participants |