Trial Outcomes & Findings for Atomoxetine to Treat Asian Adult Patients With Attention-Deficit/Hyperactivity Disorder (NCT NCT00962104)
NCT ID: NCT00962104
Last Updated: 2012-09-11
Results Overview
CAARS-Inv:SV is a scale that assesses symptom severity over past week. Total ADHD symptom score consisted of 18 items (sum of inattention \[9 items, range: 0-27\] and hyperactivity-impulsivity \[9 items, range: 0-27\] 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. Higher scores indicate greater impairment.
COMPLETED
PHASE3
391 participants
Baseline, up to 10 weeks
2012-09-11
Participant Flow
Participant milestones
| Measure |
Atomoxetine
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
195
|
196
|
|
Overall Study
Full Analysis Set
|
193
|
195
|
|
Overall Study
COMPLETED
|
155
|
171
|
|
Overall Study
NOT COMPLETED
|
40
|
25
|
Reasons for withdrawal
| Measure |
Atomoxetine
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
3
|
|
Overall Study
Entry Criteria Not Met
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
6
|
8
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
6
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
Atomoxetine to Treat Asian Adult Patients With Attention-Deficit/Hyperactivity Disorder
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=193 Participants
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=195 Participants
Taken by mouth, once daily for 10 weeks.
|
Total
n=388 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
32.8 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
31.7 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
32.3 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
193 participants
n=5 Participants
|
195 participants
n=7 Participants
|
388 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
34 participants
n=5 Participants
|
34 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
123 participants
n=5 Participants
|
124 participants
n=7 Participants
|
247 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
36 participants
n=5 Participants
|
37 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Number of Participants with the Cytochrome P450 2D6 (CYP2D6) Genotype
Extensive metabolizer (EM)
|
40 participants
n=5 Participants
|
45 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Number of Participants with the Cytochrome P450 2D6 (CYP2D6) Genotype
Intermediate metabolizer (IM)
|
137 participants
n=5 Participants
|
137 participants
n=7 Participants
|
274 participants
n=5 Participants
|
|
Number of Participants with the Cytochrome P450 2D6 (CYP2D6) Genotype
Poor metabolizer (PM)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Number of Participants with the Cytochrome P450 2D6 (CYP2D6) Genotype
Ultra-rapid metabolizer (UM)
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype Current
Inattentive
|
96 participants
n=5 Participants
|
95 participants
n=7 Participants
|
191 participants
n=5 Participants
|
|
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype Current
Hyperactive/Impulsive
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype Current
Combined
|
93 participants
n=5 Participants
|
96 participants
n=7 Participants
|
189 participants
n=5 Participants
|
|
Prior Stimulant Exposure Status
Prior Stimulant Exposure - Yes
|
43 participants
n=5 Participants
|
42 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Prior Stimulant Exposure Status
Prior Stimulant Exposure - No
|
150 participants
n=5 Participants
|
153 participants
n=7 Participants
|
303 participants
n=5 Participants
|
|
Current Major Depressive Episode Status
Major Depressive Episode - Yes
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Current Major Depressive Episode Status
Major Depressive Episode - No
|
189 participants
n=5 Participants
|
195 participants
n=7 Participants
|
384 participants
n=5 Participants
|
|
Recurrent Major Depressive Episode Status
Recurrent Major Depressive Episode - Yes
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Recurrent Major Depressive Episode Status
Recurrent Major Depressive Episode - No
|
192 participants
n=5 Participants
|
195 participants
n=7 Participants
|
387 participants
n=5 Participants
|
|
Current Major Depressive Episode with Melancholic Features Status
Current Major Depressive Episode with - Yes
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Current Major Depressive Episode with Melancholic Features Status
Current Major Depressive Episode with - No
|
191 participants
n=5 Participants
|
195 participants
n=7 Participants
|
386 participants
n=5 Participants
|
|
Current Social Phobia (Social Anxiety Disorder [SAD]) Status
Current Social Phobia (SAD) - Yes
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Current Social Phobia (Social Anxiety Disorder [SAD]) Status
Current Social Phobia (SAD) - No
|
190 participants
n=5 Participants
|
191 participants
n=7 Participants
|
381 participants
n=5 Participants
|
|
Obsessive-Compulsive Disorder (OCD) Status
Current OCD - Yes
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Obsessive-Compulsive Disorder (OCD) Status
Current OCD - No
|
192 participants
n=5 Participants
|
193 participants
n=7 Participants
|
385 participants
n=5 Participants
|
|
Conners' Adult Attention-Deficit Hyperactivity/Disorder Rating Scale-Investigator Rated: Screening V
|
33.2 units on a scale
STANDARD_DEVIATION 7.7 • n=5 Participants
|
33.9 units on a scale
STANDARD_DEVIATION 7.5 • n=7 Participants
|
33.6 units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 10 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline CAARS-Inv:SV result within each treatment group, last observation carried forward (LOCF) were included in the analysis.
CAARS-Inv:SV is a scale that assesses symptom severity over past week. Total ADHD symptom score consisted of 18 items (sum of inattention \[9 items, range: 0-27\] and hyperactivity-impulsivity \[9 items, range: 0-27\] 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. Higher scores indicate greater impairment.
Outcome measures
| Measure |
Atomoxetine
n=191 Participants
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=195 Participants
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Change From Baseline in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score up to 10 Weeks
|
-14.3 units on a scale
Standard Deviation 10.4
|
-8.8 units on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Baseline, up to 10 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline AAQoL result within each treatment group, last observation carried forward (LOCF) were included in the analysis.
Participant-reported outcome measure used to examine disease-specific functional impairments and QoL for adults with ADHD. The domains include work functioning, family relationships, social functioning, activities of daily living (that is, driving, managing finances), and psychological adaptation (that is, life satisfaction and self-esteem). Individual items scored on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). Range of scores for this subscale is 0 to 100. Consistent with the majority of existing QoL measures, higher scores on AAQoL-29 indicate better functioning.
Outcome measures
| Measure |
Atomoxetine
n=178 Participants
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=190 Participants
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks
|
12.83 units on a scale
Standard Deviation 15.91
|
8.20 units on a scale
Standard Deviation 14.09
|
SECONDARY outcome
Timeframe: Baseline, up to 10 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline EQ-5D result within each treatment group, last observation carried forward (LOCF) were included in the analysis.
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state.
Outcome measures
| Measure |
Atomoxetine
n=178 Participants
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=189 Participants
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks
|
1.4 units on a scale
Standard Deviation 20.3
|
1.5 units on a scale
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline CAARS-Inv:SV result were included in the analysis.
CAARS-Inv:SV assesses symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention \[9 items, range: 0-27\] and hyperactivity-impulsivity \[9 items, range: 0-27\] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment\*visit. Baseline included as a covariate; thus, treatment difference in observed value is same as change from baseline.
Outcome measures
| Measure |
Atomoxetine
n=190 Participants
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=195 Participants
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks
|
17.24 units on a scale
Standard Error 0.74
|
23.42 units on a scale
Standard Error 0.73
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline CAARS-S:SV result were included in the analysis.
Participant assessment of symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention \[9 items, range: 0-27\] and hyperactivity-impulsivity \[9 items, range: 0-27\] subscales) using 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment\*visit. Baseline included as covariate; thus, treatment difference in observed value is same as change from baseline.
Outcome measures
| Measure |
Atomoxetine
n=191 Participants
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=195 Participants
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Screening Version (CAARS-S:SV) 18 Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks
|
16.80 units on a scale
Standard Error 0.77
|
22.97 units on a scale
Standard Error 0.75
|
SECONDARY outcome
Timeframe: Baseline, up to 10 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline BRIEF-A result within each treatment group, last observation carried forward (LOCF) were included in the analysis.
A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75- 225 total score). Higher subscale ratings=greater perceived impairment.
Outcome measures
| Measure |
Atomoxetine
n=177 Participants
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=190 Participants
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Score up to 10 Weeks
Raw Metacognition Index (MI) Score (N=177, 189)
|
-13.6 units on a scale
Standard Deviation 17.3
|
-7.5 units on a scale
Standard Deviation 13.0
|
|
Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Score up to 10 Weeks
Raw Behavioral Regulation Index Score
|
-9.1 units on a scale
Standard Deviation 12.4
|
-5.5 units on a scale
Standard Deviation 10.3
|
|
Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Score up to 10 Weeks
Raw Global Executive Composite Score (N=175, 189)
|
-22.6 units on a scale
Standard Deviation 28.8
|
-13.0 units on a scale
Standard Deviation 22.1
|
SECONDARY outcome
Timeframe: Baseline, up to 10 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline BRIEF-A result within each treatment group, last observation carried forward (LOCF) were included in the analysis.
Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75-225 total score). Higher subscale ratings=greater perceived impairment.
Outcome measures
| Measure |
Atomoxetine
n=126 Participants
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=133 Participants
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks
Raw Behavioral Regulation Index Score (N=126, 128)
|
-5.8 units on a scale
Standard Deviation 10.7
|
-5.0 units on a scale
Standard Deviation 10.1
|
|
Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks
Raw Metacognition Index (MI) Score
|
-7.3 units on a scale
Standard Deviation 13.6
|
-7.3 units on a scale
Standard Deviation 12.8
|
|
Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks
Raw Global Executive Composite Score (N=123, 128)
|
-13.2 units on a scale
Standard Deviation 22.7
|
-12.4 units on a scale
Standard Deviation 21.6
|
SECONDARY outcome
Timeframe: Baseline, up to 10 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline CGI-ADHD-S result within each treatment group, last observation carried forward (LOCF) were included in the analysis.
The CGI-ADHD-S is a single-item clinician rating of the clinician's assessment of the overall severity of the participant's ADHD symptoms in relation to the clinician's total experience with ADHD participants. Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill to 7=among the most extremely ill participants).
Outcome measures
| Measure |
Atomoxetine
n=191 Participants
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=195 Participants
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Change From Baseline in the Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) up to 10 Weeks
|
-1.3 units on a scale
Standard Deviation 1.2
|
-0.8 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Up to 10 weeksPopulation: All randomized participants with an endpoint CGI-ADHD-I value within each treatment group, last observation carried forward (LOCF) were included in the analysis.
The CGI-ADHD-I is a single-item clinician rating of the clinician's assessment of the participant's improvement in ADHD symptoms in relation to the clinician's total experience with ADHD participants. Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment (1=very much improved to 7=very much worsened).
Outcome measures
| Measure |
Atomoxetine
n=191 Participants
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=195 Participants
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) up to 10 Weeks
|
2.84 units on a scale
Standard Deviation 0.98
|
3.28 units on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Baseline, up to 10 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline HAMA-14 result within each treatment group, last observation carried forward (LOCF) were included in the analysis.
Clinician-administered rating scale that assesses severity of anxiety and its improvement (or change) during course of treatment (Hamilton 1959; Riskind et al. 1987). Scale consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. Investigator talked to participant about participant's symptoms over previous week before study visit. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score=sum of 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate a greater degree of symptom severity.
Outcome measures
| Measure |
Atomoxetine
n=179 Participants
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=189 Participants
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Change From Baseline in the Hamilton Anxiety Rating Scale-14 Items (HAMA-14) up to 10 Weeks
|
-0.6 units on a scale
Standard Deviation 3.8
|
-0.7 units on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline, up to 10 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline HAMD-17 result within each treatment group, last observation carried forward (LOCF) were included in the analysis.
The HAMD-17 was used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). Higher scores indicate greater symptom severity. The total score is the sum of the scores from HAMD-17 Items 1 through 17. The total score may range from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate a greater degree of symptom severity.
Outcome measures
| Measure |
Atomoxetine
n=180 Participants
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=189 Participants
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Change From Baseline in the Hamilton Depression Rating Scale-17 Items (HAMD-17 Total) up to 10 Weeks
|
-0.2 units on a scale
Standard Deviation 2.9
|
-0.1 units on a scale
Standard Deviation 2.8
|
Adverse Events
Atomoxetine
Placebo
Serious adverse events
| Measure |
Atomoxetine
n=193 participants at risk
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=195 participants at risk
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.52%
1/193 • Number of events 1
|
0.00%
0/195
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/193
|
0.51%
1/195 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/193
|
0.51%
1/195 • Number of events 1
|
Other adverse events
| Measure |
Atomoxetine
n=193 participants at risk
Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
|
Placebo
n=195 participants at risk
Taken by mouth, once daily for 10 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
8.8%
17/193 • Number of events 17
|
4.6%
9/195 • Number of events 9
|
|
Gastrointestinal disorders
Dry mouth
|
10.9%
21/193 • Number of events 21
|
2.6%
5/195 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
42.0%
81/193 • Number of events 100
|
5.1%
10/195 • Number of events 11
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
13/193 • Number of events 16
|
1.0%
2/195 • Number of events 2
|
|
General disorders
Fatigue
|
5.2%
10/193 • Number of events 10
|
4.6%
9/195 • Number of events 9
|
|
General disorders
Thirst
|
10.9%
21/193 • Number of events 23
|
1.5%
3/195 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
9/193 • Number of events 9
|
12.8%
25/195 • Number of events 27
|
|
Investigations
Weight decreased
|
6.7%
13/193 • Number of events 13
|
0.51%
1/195 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.3%
45/193 • Number of events 52
|
1.0%
2/195 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
5.7%
11/193 • Number of events 13
|
1.5%
3/195 • Number of events 3
|
|
Nervous system disorders
Headache
|
12.4%
24/193 • Number of events 25
|
10.3%
20/195 • Number of events 26
|
|
Nervous system disorders
Somnolence
|
15.0%
29/193 • Number of events 32
|
11.3%
22/195 • Number of events 26
|
|
Renal and urinary disorders
Dysuria
|
5.2%
10/193 • Number of events 10
|
0.00%
0/195
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60