Safety of SPD465 in Treating Adults With 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: NCT00152035|
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : January 16, 2017
Information provided by:
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.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder With Hyperactivity||Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1040 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Multi-center, 12-month, Open-label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).|
|Study Start Date :||March 2005|
|Actual Study Completion Date :||May 2007|
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.
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