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Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106430
First Posted: April 19, 2010
Last Update Posted: June 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
Results First Submitted: May 3, 2013  
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: Lisdexamfetamine Dimesylate
Drug: Atomoxetine Hydrochloride

  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
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Reporting Groups
  Description
Lisdexamfetamine Dimesylate Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Atomoxetine Hydrochloride Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.

Participant Flow:   Overall Study
    Lisdexamfetamine Dimesylate   Atomoxetine Hydrochloride
STARTED   133   134 
COMPLETED   100   101 
NOT COMPLETED   33   33 
Adverse Event                8                10 
Lack of Efficacy                2                13 
Lost to Follow-up                5                1 
Early Termination Requested By Sponsor                1                0 
Moved Out Of State                0                1 
Refused To Take Medication                0                1 
Noncompliance                0                1 
Hard Time Swallowing The Pills                1                0 
Previous Use Of Marijuana                1                0 
Protocol Violation                7                2 
Withdrawal by Subject                8                4 



  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.
Safety Population was used for baseline characteristics (n = 262). Defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. Five randomized subjects did not take any investigational product.

Reporting Groups
  Description
Lisdexamfetamine Dimesylate Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Atomoxetine Hydrochloride Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
Total Total of all reporting groups

Baseline Measures
   Lisdexamfetamine Dimesylate   Atomoxetine Hydrochloride   Total 
Overall Participants Analyzed 
[Units: Participants]
 128   134   262 
Age 
[Units: Years]
Mean (Standard Deviation)
 10.9  (3.01)   10.4  (2.84)   10.6  (2.93) 
Age, Customized 
[Units: Participants]
     
13 - 17 years   34   34   68 
6 - 12 years   94   100   194 
Gender 
[Units: Participants]
     
Female   34   31   65 
Male   94   103   197 
Region of Enrollment [1] 
[Units: Participants]
     
BELGIUM   0   2   2 
CANADA   17   18   35 
GERMANY   20   22   42 
HUNGARY   10   10   20 
ITALY   1   0   1 
POLAND   0   1   1 
SPAIN   12   10   22 
SWEDEN   3   3   6 
UNITED STATES   70   68   138 
[1] All enrolled subjects defined as all randomized subjects (n = 267).


  Outcome Measures
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1.  Primary:   Time to First Response   [ Time Frame: 9 weeks ]

2.  Secondary:   Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)   [ Time Frame: 9 weeks ]

3.  Secondary:   Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF   [ Time Frame: Baseline and 9 weeks ]

4.  Secondary:   Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks   [ Time Frame: Baseline and up to 9 weeks ]

5.  Secondary:   Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks   [ Time Frame: up to 9 weeks ]

6.  Secondary:   Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks   [ Time Frame: Baseline and up to 9 weeks ]

7.  Secondary:   Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: 9 weeks ]

8.  Secondary:   Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1   [ Time Frame: 9 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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335


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

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01106430     History of Changes
Other Study ID Numbers: SPD489-317
2009-011745-94 ( EudraCT Number )
First Submitted: April 14, 2010
First Posted: April 19, 2010
Results First Submitted: May 3, 2013
Results First Posted: June 24, 2013
Last Update Posted: June 12, 2014