drugset / Trial / NCT07169162
ADZENYS XR-ODT™ in Children (4 to <6 Years) Diagnosed With Attention-deficit/Hyperactivity Disorder
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, double-blind, flexible dose-titration, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of ADZENYS XR-ODT compared to placebo in children with ADHD.
Timeline
- Start
- 2019-05
- Primary completion
- 2025-09-05
- Completion
- 2025-09-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amphetamine | Unknown | 3.1 mg | Oral |
| Subject | Amphetamine | Unknown | 6.3 mg | Oral |
| Subject | Amphetamine | Unknown | 9.4 mg | Oral |
| Subject | Amphetamine | Unknown | 12.5 mg | Oral |
| Subject | Amphetamine | Unknown | 15.7 mg | Oral |
| Subject | Amphetamine | Unknown | 18.8 mg | Oral |