At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 349 enrolled
Drug / intervention
Vyvanse (lisdexamfetamine dimesylate), NRP104drug
Likely dose
Vyvanse (lisdexamfetamine dimesylate), NRP104 30mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Long-Term, Open-Label, and Single-Arm Study of NRP104 30 mg, 50 mg, or 70 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
In Brief
A Phase 3 clinical trial evaluating Vyvanse (lisdexamfetamine dimesylate), NRP104 for Attention Deficit Hyperactivity Disorder and 2 related conditions. Completed, enrolled 349 participants across 45 sites.
Detailed Summary
The purpose of this study is to assess the long-term safety and efficacy of three NRP104 doses of 30 mg, 50 mg, or 70 mg, administered at the same time daily, in the treatment of adults with ADHD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity, Attention Deficit Hyperactivity Disorders
CountriesUnited States
CollaboratorsShire
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2006
Enrollment StartJul 2006
Primary CompletionNov 2007
Study CompletionJun 2008
TodayJul 2026
First PostedJun 15, 2006
Enrollment StartJul 1, 2006
Primary CompletionNov 1, 2007
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.0 years ago
Interventions
Vyvanse (lisdexamfetamine dimesylate), NRP104drug
NRP104 capsule once-a-day orally beginning at 30mg/day and titrated by 20 mg per day at weekly intervals up to a maximum daily dose of 70 mg