drugset / Trial / NCT00866996
Community-based Study Comparing Extended-release Methylphenidate and Atomoxetine in Children With Attention-deficit Hyperactivity Disorder
Phase 4
Completed
1323 enrolled
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study was to better understand the treatment outcomes of extended-release methylphenidate and atomoxetine in children with attention-deficit hyperactivity disorder (ADHD) as evaluated by physicians and parents in a community setting.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- 2003-12
Publications
- Results Kemner JE, Starr HL, Ciccone PE, Hooper-Wood CG, Crockett RS. Outcomes of OROS methylphenidate compared with atomoxetine in children with ADHD: a multicenter, randomized prospective study. Adv Ther. 2005 Sep-Oct;22(5):498-512. doi: 10.1007/BF02849870.
- Results Starr HL, Kemner J. Multicenter, randomized, open-label study of OROS methylphenidate versus atomoxetine: treatment outcomes in African-American children with ADHD. J Natl Med Assoc. 2005 Oct;97(10 Suppl):11S-16S.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atomoxetine | Other / unclassified | 0.5 mg/kg | Oral |
| Subject | Methylphenidate | Small molecule | 18 mg | Oral |