drugset / Trial / NCT04085172
A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)
RandomizedParallel-groupTriple-blindTreatment
Summary
The main aim of this study is learn more about long-term TAK-503 treatment in children and teenagers with ADHD for whom earlier stimulant treatment did not work. The study has two parts (A and B). In Part A, participants will take tablets of TAK-503, atomoxetine or placebo and in Part B TAK-503 tablets.
Timeline
- Start
- 2019-09-18
- Primary completion
- 2025-09-02
- Completion
- 2025-09-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atomoxetine | Other / unclassified | 1.2 mg/kg | Oral |
| Comparator | Atomoxetine | Other / unclassified | 10 mg | Oral |
| Comparator | Atomoxetine | Other / unclassified | 18 mg | Oral |
| Comparator | Atomoxetine | Other / unclassified | 25 mg | Oral |
| Comparator | Atomoxetine | Other / unclassified | 40 mg | Oral |
| Comparator | Atomoxetine | Other / unclassified | 60 mg | Oral |
| Comparator | Atomoxetine | Other / unclassified | 80 mg | Oral |
| Comparator | Atomoxetine | Other / unclassified | 100 mg | Oral |
| Subject | Guanfacine | Small molecule | 1 mg | Oral |
| Subject | Guanfacine | Small molecule | 4 mg | Oral |
| Subject | Guanfacine | Small molecule | 5 mg | Oral |
| Subject | Guanfacine | Small molecule | 7 mg | Oral |