Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02683265 · ClinicalTrials.gov registry record · Phase 4
A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD
A Phase 4 study, sponsored by Rhodes Pharmaceuticals, L.P..
- Completed
- Registry status
- Phase 4
- Development phase
- 158
- Enrollment target
NCT02683265 is a Phase 4 study that has completed, run by Rhodes Pharmaceuticals, L.P.. The registered enrollment target is 158 participants.
The verdict
NCT02683265, a Phase 4 study, has completed, sponsored by Rhodes Pharmaceuticals, L.P..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 158 participants
- Enrollment target
Study Summary
This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is designed to evaluate Aptensio XR® compared to placebo in preschool age children with ADHD. Male and female children ages 4 years, 0 months to 5 years, 8 months with a diagnosis of ADHD (combined, inattentive or hyperactive/impulsive) will be enrolled. There will be 6 phases in this study: a screening phase of up to 4 weeks, which will include washout if applicable, an enrollment \& parent training phase lasting 2-4 weeks, an eligibility phase of up to 2 weeks to determine eligibility for the open-label phase, a 6-week open-label dose titration phase, a 2 week double-blind phase for Aptensio XR® responders, and a two-week follow-up call after study completion or early discontinuation to assess for ongoing adverse events and concomitant medications. Up to 150 subjects will be enrolled in this trial to allow for subjects who improve significantly during the behavior training phase and drop-outs. Once 74 subjects have completed the double-blind phase, no additional subjects will be enrolled in the trial. Subjects who are already enrolled at that time will be allowed to complete the trial. The primary objective of this study is to establish that an optimal dose of Aptensio XR® will result in a significant reduction in ADHD symptoms compared with placebo in children ages 4 to under 6 years.
Interventions
- DRUG Placebo
- DRUG Aptensio XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2016-04-25 |
| Est. Completion | 2018-03-27 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02683265
The ClinicalTrials.gov registry entry for NCT02683265 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhodes Pharmaceuticals, L.P., which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02683265 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02683265 about?
NCT02683265 is a clinical study titled "A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD". This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is designed to evaluate Aptensio XR® compared to placebo in preschool age children with ADHD. Male and female children ages 4 years, 0 months to 5 years, 8 months with a diagnosis of ADHD (combined, inattentive or...
What is the current status of trial NCT02683265?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 158 participants. The study started on 2016-04-25. Estimated completion is 2018-03-27.
What interventions are being tested in trial NCT02683265?
The interventions under investigation include: Placebo (DRUG), Aptensio XR (DRUG).
Who is sponsoring clinical trial NCT02683265?
This trial is sponsored by Rhodes Pharmaceuticals, L.P., which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.