Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00152022|
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : January 16, 2017
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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.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder With Hyperactivity||Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||412 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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).|
|Study Start Date :||April 2005|
|Study Completion Date :||April 2006|
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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