A Randomized, Double-Blind Study of the Time Course of Response to Biphentin Methylphenidate Hydrochloride ER Capsules Compared to Placebo in Children 6 to 12 Years With Attention Deficit Hyperactivity Disorder in Analog Classroom Setting.

Trial Profile

A Randomized, Double-Blind Study of the Time Course of Response to Biphentin Methylphenidate Hydrochloride ER Capsules Compared to Placebo in Children 6 to 12 Years With Attention Deficit Hyperactivity Disorder in Analog Classroom Setting.

Completed
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
  • Most Recent Events

    • 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 700191334].
    • 22 May 2015 Primary endpoint of 'Comparison following treatment between drug and placebo using evaluation by SKAMP Combined, Attention, and Deportment Scales' has been met, according to a Rhodes Pharmaceuticals media release.
    • 23 Jan 2013 Actual end date changed from Aug 2011 to Feb 2012, as reported by ClinicalTrials.gov.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top