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NCT02604407 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
A Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 275
- Enrollment target
- 20
- Study locations
NCT02604407 is a Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD) that has completed, run by Shire. The registered enrollment target is 275 participants, above the 129-participant average among 15 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (113% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT02604407, a Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 275 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG SHP465 12.5mg capsules (one capsule daily)
- DRUG SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
Study Locations (20)
Florida
- Florida Clinical Research Center Llc - Bradenton
- Gulfcoast Clinical Research Center - Fort Myers
- Sarkis Clinical Trials - Gainesville
- Clinical Neuroscience Solutions, Inc - Jacksonville
- Florida Clinical Research Center, Llc - Maitland
- Qps Mra, Llc - Miami
- Medical Research Group of Central Florida - Orange City
- Clinical Neuroscience Solutions, Inc - Orlando
California
- Pharmacology Research Institute - Encino
- Pharmacology Research Institute (Pri) - Los Alamitos
- Pharmacology Research Institute (Pri) - Newport Beach
- Nrc Research Institute - Orange
- Elite Clinical Trials - Wildomar
Illinois
- Capstone Clinical - Libertyville
- Baber Research Group, Inc - Naperville
Colorado
- McB Clinical Research - Colorado Springs
Georgia
- Northwest Behavioral Research Center - Marietta
Kansas
- Psychiatric Associates - Overland Park
Louisiana
- Louisiana Research Associates, Inc. - New Orleans
Michigan
- Rochester Center For Behavioral Medicine - Rochester Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2015-11-19 |
| Est. Completion | 2016-03-24 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02604407
The ClinicalTrials.gov registry entry for NCT02604407 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 129-participant average among 15 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (113% higher). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder (ADHD) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02604407 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT02604407 about?
NCT02604407 is a clinical study titled "Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)". The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.
What is the current status of trial NCT02604407?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 275 participants. The study started on 2015-11-19. Estimated completion is 2016-03-24.
What conditions does trial NCT02604407 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder (ADHD).
What interventions are being tested in trial NCT02604407?
The interventions under investigation include: Placebo (OTHER), SHP465 12.5mg capsules (one capsule daily) (DRUG), SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily) (DRUG).
Who is sponsoring clinical trial NCT02604407?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02604407 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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