drugset / Trial / NCT00507065

Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00507065

Phase 3 Completed 329 enrolled Shire
RandomizedParallel-groupDouble-blindTreatment

Summary

Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (\<= 75 kg or \> 75 kg).

Timeline

Start
2003-05-28
Primary completion
2004-03-24
Completion
2004-03-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 10 mg
Subject Methylphenidate Small molecule 20 mg
Subject Methylphenidate Small molecule 30 mg
Subject Methylphenidate Small molecule 40 mg