Status:
COMPLETED
Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD
Lead Sponsor:
Noven Therapeutics
Collaborating Sponsors:
Noven Pharmaceuticals, Inc.
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
Detailed Description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of...
Eligibility Criteria
Inclusion
- Subjects have primary diagnosis of ADHD
- Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
- Subject has an IQ score of \>\_ 80
- Subject is able to complete as least the Basic Test of the PERMP assessment
Exclusion
- Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
- Subject is taking Strattera(r)
- Subject has a recent history of suspected substance abuse or dependence disorder
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00151970
Start Date
June 1 2005
End Date
October 1 2006
Last Update
July 9 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.