Status:
COMPLETED
A Safety and Effectiveness Study of Methylphenidate HCl Extended-release Tablets in Adults With Attention Deficit Hyperactivity Disorder
Lead Sponsor:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of methylphenidate HCl extended-release tablets at five dose levels compared to placebo in adults with Attention Deficit Hyperacti...
Detailed Description
This is a randomized (patients are assigned different treatments based on chance), placebo-controlled , double-blind (neither the patient nor the physician knows whether drug or placebo is being taken...
Eligibility Criteria
Inclusion
- Investigator determined diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria with symptomatology from childhood to adulthood, symptoms present before age seven years and continue to meet full DSM-IV criteria at time of assessment
- Diagnosis confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) at Baseline and Adult ADHD Investigator Symptom Rating Scale (AISRS) score of 24 or greater as determined by the Investigator at Baseline
- Global Assessment of Functioning (GAF) Scale score of 41 to 60, inclusive, at Baseline
- Minimum weight of 100 lbs (45.4 kg) at Screening
- Negative urine drug test at the Screening and Baseline Visits when tested for drugs of abuse
Exclusion
- Known to be non-responders to methylphenidate or other stimulants for the treatment of ADHD
- History of allergy, sensitivity or contraindication to methylphenidate or components of methylphenidate HCL extended-release tablets
- Coexisting medical condition or taking concomitant medication that would interfere with safe administration of methylphenidate in the Investigator's opinion
- Known structural cardiac abnormality
- Diagnosis of or family history of Tourette's syndrome, or motor or verbal tics
- history of seizures or a seizure disorder other than febrile seizures in childhood
- Glaucoma
- Uncontrolled hyperthyroidism or hypothyroidism
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT00326391
Start Date
April 1 2006
End Date
December 1 2006
Last Update
May 24 2011
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