Status:
COMPLETED
Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
Shire
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
13-17 years
Phase:
PHASE3
Brief Summary
The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.
Eligibility Criteria
Inclusion
- Meet DSM-IV-TR criteria for a primary diagnosis of ADHD
- Baseline ADHD-RS-IV score \>=28
- BP w/in 95th percentile for age, gender, and height
Exclusion
- Subject has controlled or uncontrolled comorbid psychiatric diagnosis
- Subject has conduct disorder
- Suicidal
- Under or overweight
- Concurrent chronic or acute illness that might confound results.
Key Trial Info
Start Date :
October 8 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2009
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT00735371
Start Date
October 8 2008
End Date
April 6 2009
Last Update
June 14 2021
Active Locations (45)
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1
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
2
Valley Clinical Research, Inc.
El Centro, California, United States, 92243
3
Peninsula Research Associates, Inc
Rolling Hills Estates, California, United States, 90274
4
Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)
San Diego, California, United States, 92108