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| Sponsors and Collaborators: |
New River Pharmaceuticals Shire Pharmaceutical Development |
|---|---|
| Information provided by: | New River Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00337285 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder Attention Deficit Disorders With Hyperactivity Attention Deficit Hyperactivity Disorders |
Drug: Vyvanse (lisdexamfetamine dimesylate), NRP104 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 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) |
| Enrollment: | 348 |
| Study Start Date: | July 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Vyvanse (lisdexamfetamine dimesylate), NRP104
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 45 Study Locations| Principal Investigator: | Joseph Biederman, M.D. | Massachusetts General Hospital |
More Information
| Responsible Party: | Shire Pharmaceutical ( Timothy Whitaker, M.D. ) |
| Study ID Numbers: | NRP104.304 |
| Study First Received: | June 9, 2006 |
| Last Updated: | December 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00337285 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Attention Deficit Hyperactivity Disorder Attention Deficit Disorders with Hyperactivity Attention Deficit Hyperactivity Disorders |
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Dopamine Uptake Inhibitors Neurotransmitter Agents Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Dyskinesias Signs and Symptoms Dopamine |
Attention Deficit Disorder with Hyperactivity Mental Disorders Dextroamphetamine Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents |
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Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Dyskinesias Pharmacologic Actions |
Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Dextroamphetamine Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents Central Nervous System Agents |