Status:
COMPLETED
Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Attention-Deficit/Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in...
Eligibility Criteria
Inclusion
- Male and female subjects aged 6-12 years, inclusive.
- Subjects meeting the DSM-IV criteria for primary diagnosis of ADHD-Combined type, or predominantly hyperactive-impulsive subtype, as established by the K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version). If a DSM-IV-defined ADHD diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study.
- Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to Screening visit.
Exclusion
- Subject or subject's guardian unable to understand or follow instructions necessary to participate in the study.
- Diagnosed with or history of a tic disorder or Tourette's syndrome.
- History of seizure disorder.
- The presence of a known medical condition that would preclude the use of methylphenidate.
- A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease.
- ALT (Alanine Amino Transferase), AST (Aspartate Amino Transferase), GGT (Gamma glutamyl transferase) or serum creatinine greater then 2X the ULN (Upper Limit of Normal) at Screening.
- A history of psychiatric illness or substance use disorder (e.g., schizophrenia, bipolar disorder, autism, abuse or dependence, depression, severe Conduct Disorder or severe Oppositional defiant disorder)
- Subjects who have participated in an investigational trial within the past 4 weeks (28 days)
- Subjects who are currently taking antidepressants or other psychotropic medication.
- Subjects who have initiated psychotherapy during the three months prior to randomization.
- Subjects with a positive urine drug screen.
- Subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00776009
Start Date
October 1 2008
End Date
December 1 2008
Last Update
June 8 2011
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Study Center, LLC
Little Rock, Arkansas, United States, 72205
2
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34208
3
Miami Research Associates
South Miami, Florida, United States, 33143
4
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212