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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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