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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00700427
First received: June 16, 2008
Last updated: June 12, 2014
Last verified: June 2014
Results First Received: August 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Interventions: Drug: atomoxetine hydrochloride
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Atomoxetine (Study Period 2) 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).
Atomoxetine (Study Period 3A) 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).
Atomoxetine (Study Period 3B) 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 (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).
Atomoxetine (Study Period 4) 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.

Participant Flow for 4 periods

Period 1:   Study Period 2 (Open-Label Acute Trx)
    Atomoxetine (Study Period 2)   Atomoxetine (Study Period 3A)   Atomoxetine (Study Period 3B)   Placebo (Study Period 3B)   Atomoxetine (Study Period 4)
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 
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 2:   Study Period 3A (Blinded Maintenance)
    Atomoxetine (Study Period 2)   Atomoxetine (Study Period 3A)   Atomoxetine (Study Period 3B)   Placebo (Study Period 3B)   Atomoxetine (Study Period 4)
STARTED   0   1005   0   0   0 
COMPLETED   0   524   0   0   0 
NOT COMPLETED   0   481   0   0   0 
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 3:   Study Period 3B (Randomized Withdrawal)
    Atomoxetine (Study Period 2)   Atomoxetine (Study Period 3A)   Atomoxetine (Study Period 3B)   Placebo (Study Period 3B)   Atomoxetine (Study Period 4)
STARTED   0   0   266   258   0 
COMPLETED   0   0   184   165   0 
NOT COMPLETED   0   0   82   93   0 
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 4:   Study Period 4 (Open-Label Extension)
    Atomoxetine (Study Period 2)   Atomoxetine (Study Period 3A)   Atomoxetine (Study Period 3B)   Placebo (Study Period 3B)   Atomoxetine (Study Period 4)
STARTED   0   0   0   0   180 
COMPLETED   0   0   0   0   96 
NOT COMPLETED   0   0   0   0   84 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants.

Reporting Groups
  Description
Atomoxetine (40-100 mg) 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).

Baseline Measures
   Atomoxetine (40-100 mg) 
Overall Participants Analyzed 
[Units: Participants]
 2017 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.15  (9.09) 
Gender 
[Units: Participants]
 
Female   833 
Male   1184 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian   1765 
African   56 
Hispanic   159 
Native American   6 
East Asian   14 
West Asian   15 
Missing   2 
Region of Enrollment 
[Units: 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 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period   [ Time Frame: Baseline (Week 24) up to Week 49 ]

2.  Secondary:   Number of Days Until Relapse   [ Time Frame: Baseline (Week 24) up to Week 49 ]

3.  Secondary:   Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49   [ Time Frame: Baseline (Week 24), Week 49 ]

4.  Secondary:   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   [ Time Frame: Baseline (Week 24), Week 49 ]

5.  Secondary:   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   [ Time Frame: Baseline (Week 24), Week 49 ]

6.  Secondary:   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   [ Time Frame: Baseline (Week 24), Week 49 ]

7.  Secondary:   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   [ Time Frame: Baseline (Week 24), Week 49 ]

8.  Secondary:   Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49   [ Time Frame: Baseline (Week 24), Week 49 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 )
Study First Received: June 16, 2008
Results First Received: August 23, 2012
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration