Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191945
First received: September 12, 2005
Last updated: January 26, 2010
Last verified: January 2010
Results First Received: February 6, 2009  
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
158 patients enrolled during the Screening Period (Visits 1 and 2), but 7 did not receive study drug and are not included in the 151 patients randomized in the Double-Blind Period.

Reporting Groups
  Description
Atomoxetine Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Placebo Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Participant Flow for 2 periods

Period 1:   Double-Blind Acute Treatment
    Atomoxetine     Placebo  
STARTED     100     51  
COMPLETED     94     48  
NOT COMPLETED     6     3  
Parent's Decision                 3                 0  
Lost to Follow-up                 0                 1  
Non Protocol Compliance                 3                 0  
Physician Decision                 0                 2  

Period 2:   Open-Label Treatment Extension
    Atomoxetine     Placebo  
STARTED     94     48  
COMPLETED     94     48  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
Atomoxetine Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Placebo Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Total Total of all reporting groups

Baseline Measures
    Atomoxetine     Placebo     Total  
Number of Participants  
[units: participants]
  100     51     151  
Age  
[units: years]
Mean ± Standard Deviation
  10.3  ± 2.48     10.3  ± 2.43     10.3  ± 2.46  
Gender  
[units: participants]
     
Female     21     10     31  
Male     79     41     120  
Region of Enrollment  
[units: participants]
     
Spain     100     51     151  
Attention-Deficit/Hyperactivity Disorder Subtype  
[units: participants]
     
Inattentive     30     19     49  
Hyperactive     5     1     6  
Combined (Hyperactive-Inattentive)     64     30     94  
Not Assessed     1     1     2  
Race/Ethnicity  
[units: participants]
     
Caucasian     98     47     145  
African     0     1     1  
Hispanic     2     3     5  
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered [1]
[units: units on a scale]
Mean ± Standard Deviation
  39.1  ± 9.0     39.5  ± 9.0     39.2  ± 9.0  
Blood Pressure  
[units: mmHg]
Mean ± Standard Deviation
     
Systolic Blood Pressure     101.2  ± 10.01     100.5  ± 10.01     101.0  ± 9.98  
Diastolic Blood Pressure     57.9  ± 7.15     58.0  ± 7.68     57.9  ± 7.31  
Body Weight  
[units: kilograms]
Mean ± Standard Deviation
  37.9  ± 11.86     37.4  ± 12.18     37.7  ± 11.93  
[1] Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.



  Outcome Measures
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1.  Primary:   Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint   [ Time Frame: Week 12 ]

2.  Secondary:   Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks   [ Time Frame: Week 9 ]

3.  Secondary:   Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks   [ Time Frame: Week 6 ]

4.  Secondary:   Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks   [ Time Frame: Week 4 ]

5.  Secondary:   Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12   [ Time Frame: week 6 and week 12 ]

6.  Secondary:   Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks)   [ Time Frame: Baseline and 12 weeks ]

7.  Secondary:   Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks)   [ Time Frame: Baseline and Open-Label Endpoint (107 weeks) ]

8.  Secondary:   Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12)   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks)   [ Time Frame: Baseline to 12 weeks ]

10.  Secondary:   Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL)   [ Time Frame: Baseline ]

11.  Secondary:   Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension)   [ Time Frame: Week 107 ]

12.  Secondary:   Vital Signs - Systolic Blood Pressure   [ Time Frame: Baseline and 12 weeks ]

13.  Secondary:   Vital Signs - Diastolic Blood Pressure   [ Time Frame: Baseline and 12 weeks ]

14.  Secondary:   Vital Signs - Pulse   [ Time Frame: Baseline and 12 weeks ]

15.  Secondary:   Vital Signs - Weight   [ Time Frame: Baseline and 12 weeks ]


  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
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  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: 1-800-545-5979


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191945     History of Changes
Other Study ID Numbers: 8836, B4Z-XM-LYDM
Study First Received: September 12, 2005
Results First Received: February 6, 2009
Last Updated: January 26, 2010
Health Authority: Spain: Ministry of Health