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A double-blind, placebo-controlled, parallel group pivotal trial to evaluate clinical efficacy and safety of FOQUEST (methylphenidate HCl controlled-release capsules) in children aged 6 to 12 years

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Trial Profile

A double-blind, placebo-controlled, parallel group pivotal trial to evaluate clinical efficacy and safety of FOQUEST (methylphenidate HCl controlled-release capsules) in children aged 6 to 12 years

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Mar 2019

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At a glance

  • Drugs Methylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Purdue Pharma

Most Recent Events

  • 18 Mar 2019 New trial record
  • 12 Mar 2019 According to a Purdue Pharma media release, based on positive results from two pivotal trials (see profile 700305396 and 700244756) the Health Canada has issued a Notice of Compliance (NOC) for an expanded indication for FOQUEST (methylphenidate HCl controlled-release capsules), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents six years of age and older.
  • 12 Mar 2019 Primary endpoint has been met. (Improvements in their ADHD symptoms), as reported in a Purdue Pharma media release.

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