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Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00152022
First received: September 7, 2005
Last updated: November 2, 2007
Last verified: November 2007

September 7, 2005
November 2, 2007
April 2005
Not Provided
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) taken at the Baseline visit and all visits thereafter.
Same as current
Complete list of historical versions of study NCT00152022 on ClinicalTrials.gov Archive Site
  • Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET)
  • Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits
  • Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.
  • Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
A Phase III, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).

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 affects the participants sleep and how they perceive their quality of life.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity.
Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
412
April 2006
Not Provided

Inclusion Criteria:

  • Primary diagnosis of ADHD
  • Baseline ADHD-RS-IV score >= 32
  • Non-pregnant females of childbearing potential must comply with contraceptive restrictions.

Exclusion Criteria:

  • 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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00152022
SPD465-303
Not Provided
Not Provided
Shire
Not Provided
Not Provided
Shire
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP