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

This study has been completed.

Study NCT00337285 Information provided by New River Pharmaceuticals

First Received: June 9, 2006 Last Updated: August 19, 2009 History of Changes

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Conditions:	Attention Deficit Hyperactivity Disorder Attention Deficit Disorders With Hyperactivity Attention Deficit Hyperactivity Disorders
Intervention:	Drug: Vyvanse (lisdexamfetamine dimesylate), NRP104

Participant Flow

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

Baseline Characteristics

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
Number of Participants [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

1. Primary:

Change in ADHD-RS-IV Total Score From Baseline at Up to One Year

Show Outcome Measure 1

2. Secondary:

Number of Participants With Improvement on CGI-I

Show Outcome Measure 2

3. Secondary:

Change in PSQI Total Score From Baseline at Up to One Year

Show Outcome Measure 3