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| Sponsor: | New River Pharmaceuticals |
|---|---|
| Collaborator: |
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: | 349 |
| 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
Hide Study Locations| United States, Arkansas | |
| Clinical Study Centers, LLC | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Bay Area Research Institute | |
| LaFayette, California, United States, 94549 | |
| Encompass Clinical Research | |
| Spring Valley, California, United States, 91978 | |
| Peninsula Research Associates | |
| Rolling Hills Estate, California, United States, 90274 | |
| Valley Clinical Research, Inc. | |
| El Centro, California, United States, 92243 | |
| University of California, San Francisco, Dept. of Psychiatry | |
| San Francisco, California, United States, 94143 | |
| University of California, Irvine Child Development Center | |
| Irvine, California, United States, 92612 | |
| United States, Colorado | |
| Alpine Clinical Research Center | |
| Boulder, Colorado, United States, 80304 | |
| United States, Connecticut | |
| Psychiatric Medicine Center | |
| New London, Connecticut, United States, 06320 | |
| United States, Florida | |
| Clinical Neuroscience Solutions, Inc. | |
| Orlando, Florida, United States, 32806 | |
| Janus Center for Psychiatric Research LLC | |
| West Palm Beach, Florida, United States, 33407 | |
| Miami Research Associates | |
| Miami, Florida, United States, 33173 | |
| Meridien Research | |
| Tampa, Florida, United States, 33606 | |
| Gulfcoast Clinical Research Center | |
| Fort Myers, Florida, United States, 33912 | |
| United States, Georgia | |
| Carman Research | |
| Smyrna, Georgia, United States, 30080 | |
| Northwest Behavioral Research Center | |
| Roswell, Georgia, United States, 30076 | |
| United States, Kansas | |
| Psychiatric Associates | |
| Overland Park, Kansas, United States, 66211 | |
| Vince and Associates Clinical Research | |
| Overland Park, Kansas, United States, 66212 | |
| United States, Maryland | |
| Johns Hopkins at Green Spring Station | |
| Lutherville, Maryland, United States, 21093 | |
| Marc Hertzman, MD | |
| Rockville, Maryland, United States, 20852 | |
| United States, Massachusetts | |
| Masschusetts General Hospital | |
| Cambridge, Massachusetts, United States, 02138 | |
| United States, Michigan | |
| Rochester Center for Behavioral Medicine | |
| Rochester Hills, Michigan, United States, 48307 | |
| Summit Research Network (Michigan) Inc. | |
| Flint, Michigan, United States, 48507 | |
| United States, Missouri | |
| St Charles Psychiatric Associates-Midwest Research | |
| St Charles, Missouri, United States, 63301 | |
| United States, Nevada | |
| Center for Psychiatry and Behavioral Medicine | |
| Las Vegas, Nevada, United States, 89128 | |
| United States, New Jersey | |
| CNS Research Institute (CRI) | |
| Clementon, New Jersey, United States, 08021 | |
| United States, New York | |
| VA New York Harbor Healthcare System | |
| New York, New York, United States, 10010 | |
| United States, North Carolina | |
| Richard Weisler and Associates | |
| Raleigh, North Carolina, United States, 27609 | |
| Duke University ADHD Program | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| IPS Research Company | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Oregon | |
| Oregon Center for Clinical Investigations, Inc. | |
| Portland, Oregon, United States, 97210-2659 | |
| United States, Pennsylvania | |
| CNS Research Institute, P.C. | |
| Philadelphia, Pennsylvania, United States, 19149 | |
| United States, Texas | |
| Bayou City Research | |
| Houston, Texas, United States, 77007 | |
| Claghorn-Lesem Research Clinic | |
| Bellaire, Texas, United States, 77401 | |
| FutureSearch Trials | |
| Austin, Texas, United States, 78756 | |
| John M. Turnbow, MD, PA | |
| Lubbock, Texas, United States, 79423 | |
| R/D Clinical Research, Inc. | |
| Lake Jackson, Texas, United States, 77566 | |
| Red Oak Psychiatry Associates, P.A. | |
| Houston, Texas, United States, 77090 | |
| United States, Vermont | |
| Neuropsychiatric Associates | |
| Woodstock, Vermont, United States, 05091 | |
| The Clinical Study Center | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Brighton Research Group | |
| Virginia Beach, Virginia, United States, 23452 | |
| NeuroScience, Inc. | |
| Herndon, Virginia, United States, 20170 | |
| Psychiatric Alliance of the Blue Ridge Clinical Research | |
| Charlottesville, Virginia, United States, 22903 | |
| United States, Washington | |
| Summit Research Network LLC (Seattle) | |
| Seattle, Washington, United States, 98104 | |
| 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 |
| Results First Received: | May 28, 2009 |
| Last Updated: | August 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00337285 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Attention Deficit Hyperactivity Disorder Attention Deficit Disorders with Hyperactivity Attention Deficit Hyperactivity Disorders |
|
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 |