Status:

COMPLETED

Efficacy and Safety of SPD465 in 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 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 \>= 24
  • 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

Key Trial Info

Start Date :

January 27 2005

Trial Type :

INTERVENTIONAL

End Date :

June 14 2005

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT00150579

Start Date

January 27 2005

End Date

June 14 2005

Last Update

June 30 2021

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