Safety of SPD465 in Treating Adults With ADHD.
This study has been completed.
Information provided by:
First received: September 7, 2005
Last updated: November 2, 2007
Last verified: November 2007
The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.
Attention Deficit Disorder With Hyperactivity.
Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III, Multi-Center, 12-Month, Open-Label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).|
Resource links provided by NLM:
Drug Information available for: Dextroamphetamine sulfate Dextroamphetamine Amphetamine sulfate Amphetamine Sulfate ion Amphetamine aspartate Amphetamine aspartate monohydrateU.S. FDA Resources
Further study details as provided by Shire:
Primary Outcome Measures:
- The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.
Secondary Outcome Measures:
- ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.
- Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).
- Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.
|Study Start Date:||March 2005|
|Study Completion Date:||May 2007|
Contacts and Locations
No Contacts or Locations Provided