Status:
COMPLETED
Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic 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 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 ...
Eligibility Criteria
Inclusion
- Primary diagnosis of ADHD
- Baseline ADHD-RS-IV score \>= 32
- Non-pregnant females of childbearing potential must comply with contraceptive restrictions.
Exclusion
- Significantly underweight or morbidly obese
- Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
- History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
- Females who are pregnant or lactating
Key Trial Info
Start Date :
April 25 2005
Trial Type :
INTERVENTIONAL
End Date :
November 4 2005
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT00152022
Start Date
April 25 2005
End Date
November 4 2005
Last Update
July 13 2021
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