Status:
COMPLETED
Safety of SPD465 in Treating Adults With ADHD.
Lead Sponsor:
Shire
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.
Eligibility Criteria
Inclusion
- Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
- Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.
Exclusion
- Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol.
- Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
- History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
- Females who are pregnant of lactating.
Key Trial Info
Start Date :
March 10 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2006
Estimated Enrollment :
505 Patients enrolled
Trial Details
Trial ID
NCT00152035
Start Date
March 10 2005
End Date
November 7 2006
Last Update
August 23 2021
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.