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Status:

COMPLETED

Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Attention Deficit/Hyperactivity Disorder

Eligibility:

All Genders

18-60 years

Phase:

PHASE3

Brief Summary

This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Diagnosis of attention deficit/hyperactivity disorder (ADHD) which started in childhood
  • Female patients of childbearing potential must be practicing an acceptable method of contraception.
  • Exclusion criteria:
  • Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2
  • History of alcohol or substance abuse within the last six months.
  • History of seizures or use of anticonvulsant medication.
  • Any psychiatric condition that requires medication or may interfere with study participation.
  • Pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc.
  • Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder
  • Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma
  • Diagnosis or family history of Tourette's syndrome
  • Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke
  • Other protocol-defined inclusion/exclusion criteria may apply

Exclusion

    Key Trial Info

    Start Date :

    November 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2012

    Estimated Enrollment :

    725 Patients enrolled

    Trial Details

    Trial ID

    NCT01259492

    Start Date

    November 1 2010

    End Date

    August 1 2012

    Last Update

    October 7 2014

    Active Locations (68)

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    Page 1 of 17 (68 locations)

    1

    Novartis Investigative Site

    Little Rock, Arkansas, United States, 72205

    2

    Novartis Investigative Site

    Beverly Hills, California, United States, 90210

    3

    Novartis Investigative Site

    Spring Valley, California, United States, 91978-1522

    4

    Novartis Investigative Site

    Bradenton, Florida, United States, 34208