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An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00337285
First Posted: June 15, 2006
Last Update Posted: August 20, 2012
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.
Collaborator:
Shire
Information provided by:
New River Pharmaceuticals
Results First Submitted: May 28, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Attention Deficit Hyperactivity Disorder
Attention Deficit Disorders With Hyperactivity
Attention Deficit Hyperactivity Disorders
Intervention: Drug: Vyvanse (lisdexamfetamine dimesylate), NRP104

  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
Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse for up to 1 year.

Reporting Groups
  Description
Vyvanse Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.

Participant Flow:   Overall Study
    Vyvanse
STARTED   349 
COMPLETED   191 
NOT COMPLETED   158 
Withdrawal by Subject                42 
Lost to Follow-up                41 
Adverse Event                28 
Protocol Violation                27 
Lack of Efficacy                11 
Death                1 
Physician Decision                1 
Lack of protocol compliance                7 



  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
Vyvanse Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.

Baseline Measures
   Vyvanse 
Overall Participants Analyzed 
[Units: Participants]
 349 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   349 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.8  (10.1) 
Gender 
[Units: Participants]
 
Female   159 
Male   190 
Region of Enrollment 
[Units: Participants]
 
United States   349 


  Outcome Measures
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1.  Primary:   Change in ADHD-RS-IV Total Score From Baseline at Up to One Year   [ Time Frame: up to one year ]

2.  Secondary:   Number of Participants With Improvement on CGI-I   [ Time Frame: Up to 1 year ]

3.  Secondary:   Change in PSQI Total Score From Baseline at Up to One Year   [ Time Frame: up to 1 year ]


  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: Timothy Whitaker
Organization: Shire Pharmaceutical Development, Inc.
e-mail: twhitaker@shire.com


Publications of Results:

Responsible Party: Timothy Whitaker, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00337285     History of Changes
Other Study ID Numbers: NRP104.304
First Submitted: June 9, 2006
First Posted: June 15, 2006
Results First Submitted: May 28, 2009
Results First Posted: July 17, 2009
Last Update Posted: August 20, 2012