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Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01552915
First received: March 6, 2012
Last updated: December 10, 2014
Last verified: December 2014
History of Changes
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention-deficit/Hyperactivity Disorder
Interventions: Drug: Lisdexamfetamine dimesylate
Drug: Methylphenidate 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
No text entered.

Reporting Groups
  Description
Placebo Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
SPD489 Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day
OROS-MPH Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.

Participant Flow:   Overall Study
    Placebo   SPD489   OROS-MPH
STARTED   91 [1]   184 [1]   184 [2] 
COMPLETED   68   155   157 
NOT COMPLETED   23   29   27 
Adverse Event                3                14                3 
Lost to Follow-up                4                6                5 
Withdrawal by Subject                6                4                5 
Protocol Violation                0                4                4 
Lack of Efficacy                8                1                4 
Not specified                2                0                6 
[1] This population is from the Safety Set. Two randomized subjects were not dosed and were excluded.
[2] This population is from the Safety Set. One randomized subject was not dosed and was excluded.



  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 Set: All subjects in the Randomized Set who took at least 1 dose of investigational product.

Reporting Groups
  Description
Placebo Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
SPD489 Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
OROS-MPH Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
Total Total of all reporting groups

Baseline Measures
   Placebo   SPD489   OROS-MPH   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 91   184   184   459 
Age 
[Units: Years]
Mean (Standard Deviation) 		 14.8  (1.43)   14.7  (1.38)   14.7  (1.32)   14.7  (1.37) 
Age, Customized 
[Units: Participants]
 		       
<=18 years   91   184   184   459 
Gender 
[Units: Participants]
 		       
Female   30   62   62   154 
Male   61   122   122   305 
Region of Enrollment 
[Units: Participants]
 		       
UNITED STATES   91   184   184   459 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8   [ Time Frame: Baseline and week 8 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)   [ Time Frame: Week 8 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment   [ Time Frame: Baseline and up to 8 Weeks ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment   [ Time Frame: Baseline and up to 8 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment   [ Time Frame: Baseline and up to 8 weeks ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  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



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01552915     History of Changes
Other Study ID Numbers: SPD489-405
Study First Received: March 6, 2012
Results First Received: December 3, 2014
Last Updated: December 10, 2014