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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: Completed Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Shire.
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 126-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (118% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The ADHD-RS was developed to measure the behaviors of children with Attention deficit hyperactivity disorder (ADHD). The adult ADHD-RS with prompts consists of 18 items designated to reflect current symptomatology of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher score = more se
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 |
What the finished NCT02604407 record still lists
NCT02604407 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, above the 126-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (118% higher).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Attention Deficit Hyperactivity Disorder (ADHD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02604407's enrollment target sits among peer trials
275 3rd of 18 higher than 16 of 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder (ADHD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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