A Randomized, Parallel, Double-Blind Efficacy and Safety Study of Biphentin Methylphenidate HCl Extended Release Capsules Compared to Placebo in Children and Adolescents 6 to 18 Years With Attention Deficit Hyperactivity Disorder (ADHD).
Phase of Trial: Phase III
Latest Information Update: 22 May 2015
At a glance
- Drugs Methylphenidate (Primary)
- Indications Attention-deficit hyperactivity disorder
- Focus Registrational; Therapeutic Use
- Sponsors Rhodes Pharmaceuticals
- 22 May 2015 Aptensio XR [methyphenidate extended release] was approved by the U.S. FDA based on the data from this and another phase III trial [see CT profile 700192830].
- 01 Feb 2012 Actual end date (Nov 2011) added as reported by ClinicalTrials.gov.
- 01 Feb 2012 Status changed from recruiting to completed as reported by ClinicalTrials.gov.