Status:
COMPLETED
The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
Shire
Conditions:
Attention-Deficit/Hyperactivity Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with place...
Eligibility Criteria
Inclusion
- Adult men and non-pregnant women between the ages of 18 and 55
- Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- Baseline ADHD score of at least 24
Exclusion
- Weight less than 100 pounds or greater than 250 pounds
- Psychiatric diagnosis such as a severe comorbid Axis II or Axis I disorder
- Pregnancy or breastfeeding
- History of seizures
- Positive urine drug screen
Key Trial Info
Start Date :
June 14 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2004
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00928148
Start Date
June 14 2004
End Date
November 20 2004
Last Update
June 3 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.