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A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT00700427
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : May 29, 2013
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Drug: atomoxetine hydrochloride
Drug: Placebo
Enrollment 2017
Recruitment Details  
Pre-assignment Details The study consisted of 4 treatment periods: 12 weeks open-label, acute-treatment (trx) phase (Study Period 2), 12 weeks double-blind maintenance phase of Study Period 3 (Study Period 3A), 25 weeks double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B) and an Open-Label Extension Period (Study Period 4) lasting up to 2.3 years.
Arm/Group Title Atomoxetine (Study Period 2) Atomoxetine (Study Period 3A) Atomoxetine (Study Period 3B) Placebo (Study Period 3B) Atomoxetine (Study Period 4)
Hide Arm/Group Description 40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2). 40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during double-blind randomized withdrawal phase (Study Period 3). 80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B). Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B). Participants who received either atomoxetine or placebo and completed the last visit of Study Period 3 who were in countries where the adult ADHD indication for atomoxetine was not approved were allowed to participant in Study Period 4 (Open-label Extension). Participants received 40 mg/day atomoxetine orally for at least 7 days after which it was increased to 80-100 mg/day atomoxetine orally for up to 2.3 years.
Period Title: Study Period 2 (Open-Label Acute Trx)
Started 2017 0 0 0 0
Received at Least One Dose of Study Drug 2011 0 0 0 0
Completed 1006 [1] 0 0 0 0
Not Completed 1011 0 0 0 0
Reason Not Completed
Adverse Event             298             0             0             0             0
Protocol Violation             173             0             0             0             0
Withdrawal by Subject             164             0             0             0             0
Protocol Interim Criteria Not Met             161             0             0             0             0
Lost to Follow-up             108             0             0             0             0
Lack of Efficacy             90             0             0             0             0
Physician Decision             8             0             0             0             0
Clinical Relapse             7             0             0             0             0
Entry Criteria Not Met             2             0             0             0             0
[1]
One participant was mistakenly recorded as completed. The reason for discontinuation is unknown.
Period Title: Study Period 3A (Blinded Maintenance)
Started 0 1005 0 0 0
Completed 0 524 0 0 0
Not Completed 0 481 0 0 0
Reason Not Completed
Adverse Event             0             50             0             0             0
Protocol Interim Criteria Not Met             0             162             0             0             0
Withdrawal by Subject             0             81             0             0             0
Protocol Violation             0             56             0             0             0
Clinical Relapse             0             49             0             0             0
Lost to Follow-up             0             41             0             0             0
Lack of Efficacy             0             32             0             0             0
Sponsor Decision             0             3             0             0             0
Physician Decision             0             2             0             0             0
Missing - Not Otherwise Defined             0             5             0             0             0
Period Title: Study Period 3B (Randomized Withdrawal)
Started 0 0 266 258 0
Completed 0 0 184 165 0
Not Completed 0 0 82 93 0
Reason Not Completed
Adverse Event             0             0             8             5             0
Withdrawal by Subject             0             0             25             34             0
Protocol Violation             0             0             23             25             0
Lost to Follow-up             0             0             19             9             0
Lack of Efficacy             0             0             3             11             0
Protocol Interim Criteria Not Met             0             0             0             5             0
Clinical Relapse             0             0             0             3             0
Missing             0             0             1             1             0
Physician Decision             0             0             2             0             0
Death             0             0             1             0             0
Period Title: Study Period 4 (Open-Label Extension)
Started 0 0 0 0 180
Completed 0 0 0 0 96
Not Completed 0 0 0 0 84
Reason Not Completed
Adverse Event             0             0             0             0             16
Death             0             0             0             0             1
Protocol Violation             0             0             0             0             12
Withdrawal by Subject             0             0             0             0             38
Physician Decision             0             0             0             0             2
Sponsor Decision             0             0             0             0             2
Lack of Efficacy             0             0             0             0             1
Lost to Follow-up             0             0             0             0             11
Clinical Relapse             0             0             0             0             1
Arm/Group Title Atomoxetine (40-100 mg)
Hide Arm/Group Description 40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment period (Study Period 2).
Overall Number of Baseline Participants 2017
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2017 participants
33.15  (9.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2017 participants
Female
833
  41.3%
Male
1184
  58.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2017 participants
Caucasian 1765
African 56
Hispanic 159
Native American 6
East Asian 14
West Asian 15
Missing 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2017 participants
Argentina 27
Austria 109
Belgium 137
Canada 60
Denmark 15
Finland 52
France 65
Germany 434
Italy 32
Mexico 53
Netherlands 71
Portugal 3
Puerto Rico 52
Russian Federation 6
Spain 153
Sweden 112
Switzerland 7
United Kingdom 27
United States 602
1.Primary Outcome
Title Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period
Hide Description Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.
Time Frame Baseline (Week 24) up to Week 49
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary outcome measure analysis was conducted using all randomized participants in the Double-Blind Maintenance/Randomized Withdrawal Period (Study Period 3B).
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Overall Number of Participants Analyzed 266 258
Measure Type: Number
Unit of Measure: percentage of responders
64.3 50.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Number of Days Until Relapse
Hide Description

Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed.

CAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).

Time Frame Baseline (Week 24) up to Week 49
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyses were conducted using all randomized participants in the Double-Blind Period (Study Period 3B).
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Overall Number of Participants Analyzed 266 258
Mean (Standard Deviation)
Unit of Measure: days
NA [1]   (NA) NA [1]   (NA)
[1]
The mean and standard deviation could not be reliably estimated because of low numbers of participants who relapsed.
3.Secondary Outcome
Title Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49
Hide Description The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site.
Time Frame Baseline (Week 24), Week 49
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline AAQoL score were included in the analysis.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Overall Number of Participants Analyzed 198 180
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.4  (1.12) -4.0  (1.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49
Hide Description The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.
Time Frame Baseline (Week 24), Week 49
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with a non-missing baseline and at least 1 post-baseline CAARS-O:SV result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Overall Number of Participants Analyzed 165 153
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
ADHD Imputed (Attributed) Index Score (N=164, 153) -2.60  (0.56) -0.10  (0.57)
Hyperactivity/Impulsivity Subscale Imputed Score -1.90  (0.44) -0.10  (0.44)
Inattention Subscale Imputed Score -1.60  (0.46) -0.10  (0.46)
Total ADHD Symptom Imputed Score -3.50  (0.83) -0.40  (0.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for ADHD Imputed (Attributed) Index Score.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value for Hyperactivity/Impulsivity Subscale Imputed Score.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P-value for Inattention Subscale Imputed Score.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value for Total ADHD Symptom Imputed Score.
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49
Hide Description CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.
Time Frame Baseline (Week 24), Week 49
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with a non-missing baseline and at least 1 post-baseline CAARS-S:SV result within each treatment group, Last Observation Carried Forward (LOCF).
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Overall Number of Participants Analyzed 193 178
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
ADHD Symptom Imputed Index Score -1.20  (0.44) 0.90  (0.43)
Hyperactivity-Impulsivity Subscale Imputed Score -0.90  (0.33) 0.50  (0.32)
Inattention Subscale Imputed Score -0.70  (0.38) 1.20  (0.37)
Total ADHD Symptom Imputed Score -1.60  (0.65) 1.70  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for ADHD Imputed (Attributed) Index Score.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Hyperactivity/Impulsivity Subscale Imputed Score.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Inattention Subscale Imputed Score.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Total ADHD Symptom Imputed Score.
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49
Hide Description The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.
Time Frame Baseline (Week 24), Week 49
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Self Report result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Overall Number of Participants Analyzed 187 173
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.70  (1.88) 0.90  (1.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49
Hide Description BRIEF-A:Informant is a 75-item third-party observer’s view of the participants’ executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.
Time Frame Baseline (Week 24), Week 49
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Informant result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Overall Number of Participants Analyzed 154 147
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.4  (2.16) -0.6  (2.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49
Hide Description The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with <0 interpreted as a health state “worse than dead.” A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline.
Time Frame Baseline (Week 24), Week 49
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with a non-missing baseline and at least 1 post-baseline EQ-5D Index Score or VAS score within each group, Last Observation Carried Forward (LOCF) were included in the analysis.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
Overall Number of Participants Analyzed 197 180
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
UK population-based Index Score (n=194, 180) 0.00  (0.01) 0.00  (0.01)
US population-based Index Score (n=194, 180) 0.00  (0.01) 0.00  (0.01)
Health State Score (N=197, 179) 4.60  (1.21) 3.20  (1.19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atomoxetine (Study Periods 2 and 3A) Atomoxetine (Study Period 3B) Placebo (Study Period 3B) Atomoxetine (Study Period 4; Open-Label Extension)
Hide Arm/Group Description 40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).

40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).

Followed by 80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).

40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).

Followed by Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).

40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A) and for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B), followed by a 2 year open label extension (Study Period 4). The open-label extension was optional and only offered to participants living in countries where atomoxetine for the adult ADHD indication had not been approved who had completed the Study Period 3B and were receiving benefit from the drug.
All-Cause Mortality
Atomoxetine (Study Periods 2 and 3A) Atomoxetine (Study Period 3B) Placebo (Study Period 3B) Atomoxetine (Study Period 4; Open-Label Extension)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Atomoxetine (Study Periods 2 and 3A) Atomoxetine (Study Period 3B) Placebo (Study Period 3B) Atomoxetine (Study Period 4; Open-Label Extension)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/2011 (1.44%)      7/266 (2.63%)      3/258 (1.16%)      14/180 (7.78%)    
Cardiac disorders         
Myocardial infarction  1  1/2011 (0.05%)  1 1/266 (0.38%)  1 1/258 (0.39%)  1 0/180 (0.00%)  0
Palpitations  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Gastrointestinal disorders         
Gastrooesophageal reflux disease  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 1/258 (0.39%)  1 1/180 (0.56%)  1
Intestinal obstruction  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Umbilical hernia  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Hepatobiliary disorders         
Cholecystitis  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 2/180 (1.11%)  2
Hepatitis alcoholic  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Infections and infestations         
Appendicitis  1  2/2011 (0.10%)  2 1/266 (0.38%)  1 0/258 (0.00%)  0 0/180 (0.00%)  0
Erysipelas  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Gastroenteritis  1  1/2011 (0.05%)  1 1/266 (0.38%)  1 0/258 (0.00%)  0 0/180 (0.00%)  0
Peritonsillar abscess  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 1/258 (0.39%)  1 0/180 (0.00%)  0
Injury, poisoning and procedural complications         
Accidental overdose  1  4/2011 (0.20%)  4 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Diaphragmatic injury  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Fall  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Foot fracture  1  1/2011 (0.05%)  1 1/266 (0.38%)  1 0/258 (0.00%)  0 0/180 (0.00%)  0
Intentional overdose  1  2/2011 (0.10%)  2 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Lower limb fracture  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Meniscus injury  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Road traffic accident  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 2/180 (1.11%)  2
Splenic injury  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Toxicity to various agents  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Musculoskeletal and connective tissue disorders         
Back pain  1  2/2011 (0.10%)  2 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Intervertebral disc protrusion  1  2/2011 (0.10%)  2 1/266 (0.38%)  1 0/258 (0.00%)  0 0/180 (0.00%)  0
Pain in extremity  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Intraductal proliferative breast lesion  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Nervous system disorders         
Cerebellar infarction  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Convulsion  1  0/2011 (0.00%)  0 1/266 (0.38%)  1 0/258 (0.00%)  0 0/180 (0.00%)  0
Headache  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Hypoaesthesia  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Psychiatric disorders         
Alcohol abuse  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Depressive symptom  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Hallucination, auditory  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Insomnia  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Restlessness  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Suicidal ideation  1  3/2011 (0.15%)  3 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Reproductive system and breast disorders         
Uterine polyp  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Skin and subcutaneous tissue disorders         
Angioedema  1  0/2011 (0.00%)  0 1/266 (0.38%)  1 0/258 (0.00%)  0 0/180 (0.00%)  0
Surgical and medical procedures         
Bunion operation  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Hospitalisation  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Skin neoplasm excision  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Tonsillectomy  1  0/2011 (0.00%)  0 1/266 (0.38%)  1 0/258 (0.00%)  0 0/180 (0.00%)  0
Vascular disorders         
Haemorrhage  1  1/2011 (0.05%)  1 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Atomoxetine (Study Periods 2 and 3A) Atomoxetine (Study Period 3B) Placebo (Study Period 3B) Atomoxetine (Study Period 4; Open-Label Extension)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1611/2011 (80.11%)      120/266 (45.11%)      96/258 (37.21%)      119/180 (66.11%)    
Cardiac disorders         
Angina pectoris  1  2/2011 (0.10%)  2 2/266 (0.75%)  2 0/258 (0.00%)  0 3/180 (1.67%)  3
Palpitations  1  83/2011 (4.13%)  90 1/266 (0.38%)  1 1/258 (0.39%)  1 2/180 (1.11%)  2
Tachycardia  1  70/2011 (3.48%)  73 3/266 (1.13%)  4 1/258 (0.39%)  1 2/180 (1.11%)  2
Ear and labyrinth disorders         
Vertigo  1  38/2011 (1.89%)  46 0/266 (0.00%)  0 1/258 (0.39%)  1 3/180 (1.67%)  4
Eye disorders         
Conjunctivitis  1  8/2011 (0.40%)  8 0/266 (0.00%)  0 1/258 (0.39%)  1 2/180 (1.11%)  2
Vision blurred  1  32/2011 (1.59%)  32 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Gastrointestinal disorders         
Abdominal discomfort  1  29/2011 (1.44%)  30 1/266 (0.38%)  1 0/258 (0.00%)  0 0/180 (0.00%)  0
Abdominal pain  1  38/2011 (1.89%)  41 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Abdominal pain upper  1  61/2011 (3.03%)  73 2/266 (0.75%)  2 2/258 (0.78%)  2 3/180 (1.67%)  3
Constipation  1  93/2011 (4.62%)  99 1/266 (0.38%)  1 0/258 (0.00%)  0 2/180 (1.11%)  2
Diarrhoea  1  53/2011 (2.64%)  60 4/266 (1.50%)  4 5/258 (1.94%)  5 8/180 (4.44%)  10
Dry mouth  1  342/2011 (17.01%)  368 3/266 (1.13%)  4 2/258 (0.78%)  2 6/180 (3.33%)  6
Dyspepsia  1  65/2011 (3.23%)  72 1/266 (0.38%)  1 0/258 (0.00%)  0 6/180 (3.33%)  6
Gastritis  1  4/2011 (0.20%)  4 1/266 (0.38%)  1 0/258 (0.00%)  0 6/180 (3.33%)  6
Haemorrhoids  1  4/2011 (0.20%)  5 1/266 (0.38%)  1 0/258 (0.00%)  0 2/180 (1.11%)  2
Nausea  1  552/2011 (27.45%)  707 6/266 (2.26%)  6 3/258 (1.16%)  4 9/180 (5.00%)  9
Toothache  1  23/2011 (1.14%)  25 1/266 (0.38%)  1 2/258 (0.78%)  2 1/180 (0.56%)  2
Vomiting  1  82/2011 (4.08%)  96 1/266 (0.38%)  1 3/258 (1.16%)  3 1/180 (0.56%)  1
General disorders         
Chills  1  57/2011 (2.83%)  60 0/266 (0.00%)  0 0/258 (0.00%)  0 2/180 (1.11%)  2
Fatigue  1  262/2011 (13.03%)  292 1/266 (0.38%)  1 3/258 (1.16%)  3 4/180 (2.22%)  5
Influenza like illness  1  11/2011 (0.55%)  11 2/266 (0.75%)  3 1/258 (0.39%)  1 2/180 (1.11%)  2
Irritability  1  80/2011 (3.98%)  87 2/266 (0.75%)  2 0/258 (0.00%)  0 0/180 (0.00%)  0
Malaise  1  46/2011 (2.29%)  57 1/266 (0.38%)  1 0/258 (0.00%)  0 1/180 (0.56%)  1
Pyrexia  1  16/2011 (0.80%)  17 4/266 (1.50%)  4 2/258 (0.78%)  2 1/180 (0.56%)  1
Infections and infestations         
Bronchitis  1  18/2011 (0.90%)  19 3/266 (1.13%)  3 2/258 (0.78%)  2 5/180 (2.78%)  7
Cystitis  1  8/2011 (0.40%)  8 1/266 (0.38%)  1 1/258 (0.39%)  1 5/180 (2.78%)  8
Ear infection  1  2/2011 (0.10%)  2 2/266 (0.75%)  2 0/258 (0.00%)  0 2/180 (1.11%)  2
Gastroenteritis  1  24/2011 (1.19%)  24 5/266 (1.88%)  5 2/258 (0.78%)  2 5/180 (2.78%)  7
Gastrointestinal infection  1  4/2011 (0.20%)  4 0/266 (0.00%)  0 0/258 (0.00%)  0 2/180 (1.11%)  2
Herpes zoster  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 2/180 (1.11%)  2
Influenza  1  52/2011 (2.59%)  55 8/266 (3.01%)  8 6/258 (2.33%)  6 10/180 (5.56%)  10
Nasopharyngitis  1  137/2011 (6.81%)  153 18/266 (6.77%)  26 13/258 (5.04%)  16 22/180 (12.22%)  39
Pneumonia  1  1/2011 (0.05%)  1 2/266 (0.75%)  2 0/258 (0.00%)  0 2/180 (1.11%)  2
Rhinitis  1  13/2011 (0.65%)  13 1/266 (0.38%)  1 2/258 (0.78%)  2 4/180 (2.22%)  4
Sinusitis  1  23/2011 (1.14%)  24 2/266 (0.75%)  2 3/258 (1.16%)  4 4/180 (2.22%)  4
Tonsillitis  1  9/2011 (0.45%)  9 1/266 (0.38%)  1 2/258 (0.78%)  2 3/180 (1.67%)  4
Upper respiratory tract infection  1  57/2011 (2.83%)  62 11/266 (4.14%)  13 7/258 (2.71%)  7 1/180 (0.56%)  2
Urinary tract infection  1  12/2011 (0.60%)  12 1/266 (0.38%)  2 0/258 (0.00%)  0 2/180 (1.11%)  2
Injury, poisoning and procedural complications         
Arthropod bite  1  2/2011 (0.10%)  2 1/266 (0.38%)  1 0/258 (0.00%)  0 2/180 (1.11%)  2
Contusion  1  8/2011 (0.40%)  8 5/266 (1.88%)  5 0/258 (0.00%)  0 0/180 (0.00%)  0
Post-traumatic neck syndrome  1  3/2011 (0.15%)  3 0/266 (0.00%)  0 1/258 (0.39%)  1 2/180 (1.11%)  2
Investigations         
Blood pressure increased  1  13/2011 (0.65%)  13 4/266 (1.50%)  6 0/258 (0.00%)  0 3/180 (1.67%)  3
Heart rate increased  1  21/2011 (1.04%)  24 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Weight decreased  1  39/2011 (1.94%)  39 1/266 (0.38%)  1 1/258 (0.39%)  1 2/180 (1.11%)  2
Weight increased  1  13/2011 (0.65%)  13 3/266 (1.13%)  3 1/258 (0.39%)  1 2/180 (1.11%)  2
Metabolism and nutrition disorders         
Decreased appetite  1  294/2011 (14.62%)  319 1/266 (0.38%)  1 1/258 (0.39%)  1 1/180 (0.56%)  1
Increased appetite  1  10/2011 (0.50%)  10 1/266 (0.38%)  1 3/258 (1.16%)  3 0/180 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  15/2011 (0.75%)  15 2/266 (0.75%)  2 1/258 (0.39%)  1 8/180 (4.44%)  8
Back pain  1  30/2011 (1.49%)  30 3/266 (1.13%)  3 7/258 (2.71%)  7 7/180 (3.89%)  9
Intervertebral disc protrusion  1  2/2011 (0.10%)  2 0/266 (0.00%)  0 0/258 (0.00%)  0 2/180 (1.11%)  2
Neck pain  1  6/2011 (0.30%)  6 1/266 (0.38%)  1 1/258 (0.39%)  1 2/180 (1.11%)  2
Nervous system disorders         
Carpal tunnel syndrome  1  0/2011 (0.00%)  0 0/266 (0.00%)  0 0/258 (0.00%)  0 2/180 (1.11%)  2
Dizziness  1  170/2011 (8.45%)  195 1/266 (0.38%)  1 2/258 (0.78%)  2 3/180 (1.67%)  3
Headache  1  347/2011 (17.26%)  482 13/266 (4.89%)  15 11/258 (4.26%)  11 17/180 (9.44%)  38
Migraine  1  26/2011 (1.29%)  46 1/266 (0.38%)  3 1/258 (0.39%)  1 3/180 (1.67%)  3
Paraesthesia  1  74/2011 (3.68%)  76 1/266 (0.38%)  1 0/258 (0.00%)  0 2/180 (1.11%)  2
Sedation  1  26/2011 (1.29%)  27 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Somnolence  1  112/2011 (5.57%)  126 1/266 (0.38%)  1 1/258 (0.39%)  1 1/180 (0.56%)  2
Tremor  1  25/2011 (1.24%)  26 0/266 (0.00%)  0 1/258 (0.39%)  1 3/180 (1.67%)  3
Psychiatric disorders         
Abnormal dreams  1  34/2011 (1.69%)  35 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Agitation  1  28/2011 (1.39%)  32 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Anxiety  1  60/2011 (2.98%)  62 3/266 (1.13%)  3 3/258 (1.16%)  3 2/180 (1.11%)  2
Depressed mood  1  56/2011 (2.78%)  62 0/266 (0.00%)  0 2/258 (0.78%)  2 4/180 (2.22%)  5
Depression  1  34/2011 (1.69%)  34 2/266 (0.75%)  2 3/258 (1.16%)  4 1/180 (0.56%)  1
Initial insomnia  1  34/2011 (1.69%)  40 4/266 (1.50%)  4 0/258 (0.00%)  0 1/180 (0.56%)  1
Insomnia  1  177/2011 (8.80%)  209 3/266 (1.13%)  3 1/258 (0.39%)  1 4/180 (2.22%)  6
Libido decreased  1  61/2011 (3.03%)  65 2/266 (0.75%)  2 2/258 (0.78%)  2 1/180 (0.56%)  1
Middle insomnia  1  33/2011 (1.64%)  35 2/266 (0.75%)  2 0/258 (0.00%)  0 3/180 (1.67%)  3
Nervousness  1  9/2011 (0.45%)  9 1/266 (0.38%)  1 0/258 (0.00%)  0 2/180 (1.11%)  3
Restlessness  1  27/2011 (1.34%)  34 1/266 (0.38%)  1 0/258 (0.00%)  0 2/180 (1.11%)  3
Sleep disorder  1  71/2011 (3.53%)  82 1/266 (0.38%)  1 1/258 (0.39%)  1 5/180 (2.78%)  5
Renal and urinary disorders         
Dysuria  1  49/2011 (2.44%)  54 1/266 (0.38%)  1 0/258 (0.00%)  0 2/180 (1.11%)  2
Urinary hesitation  1  43/2011 (2.14%)  46 2/266 (0.75%)  2 0/258 (0.00%)  0 1/180 (0.56%)  1
Urinary retention  1  21/2011 (1.04%)  22 0/266 (0.00%)  0 0/258 (0.00%)  0 1/180 (0.56%)  1
Reproductive system and breast disorders         
Dysmenorrhoea  1  19/2011 (0.94%)  23 1/266 (0.38%)  2 1/258 (0.39%)  1 2/180 (1.11%)  2
Ejaculation disorder  1  25/2011 (1.24%)  29 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Erectile dysfunction  1  99/2011 (4.92%)  103 3/266 (1.13%)  3 0/258 (0.00%)  0 2/180 (1.11%)  2
Respiratory, thoracic and mediastinal disorders         
Asthma  1  6/2011 (0.30%)  7 0/266 (0.00%)  0 0/258 (0.00%)  0 2/180 (1.11%)  2
Cough  1  22/2011 (1.09%)  23 5/266 (1.88%)  6 1/258 (0.39%)  1 2/180 (1.11%)  2
Oropharyngeal pain  1  20/2011 (0.99%)  20 5/266 (1.88%)  5 4/258 (1.55%)  5 6/180 (3.33%)  6
Rhinitis allergic  1  5/2011 (0.25%)  5 1/266 (0.38%)  1 1/258 (0.39%)  1 2/180 (1.11%)  2
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  180/2011 (8.95%)  196 2/266 (0.75%)  2 0/258 (0.00%)  0 8/180 (4.44%)  8
Piloerection  1  23/2011 (1.14%)  25 0/266 (0.00%)  0 0/258 (0.00%)  0 0/180 (0.00%)  0
Rash  1  12/2011 (0.60%)  12 1/266 (0.38%)  1 0/258 (0.00%)  0 2/180 (1.11%)  2
Surgical and medical procedures         
Tooth extraction  1  5/2011 (0.25%)  7 0/266 (0.00%)  0 1/258 (0.39%)  1 2/180 (1.11%)  2
Vascular disorders         
Hot flush  1  56/2011 (2.78%)  61 3/266 (1.13%)  3 0/258 (0.00%)  0 1/180 (0.56%)  1
Hypertension  1  27/2011 (1.34%)  28 1/266 (0.38%)  1 0/258 (0.00%)  0 2/180 (1.11%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00700427     History of Changes
Other Study ID Numbers: 9655
B4Z-MC-LYDO ( Other Identifier: Eli Lilly and Company )
First Submitted: June 16, 2008
First Posted: June 18, 2008
Results First Submitted: August 23, 2012
Results First Posted: May 29, 2013
Last Update Posted: June 26, 2014