Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder
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|ClinicalTrials.gov Identifier: NCT00877487|
Recruitment Status : Completed
First Posted : April 7, 2009
Results First Posted : August 2, 2011
Last Update Posted : June 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Attention-Deficit/Hyperactivity Disorder||Drug: SPD489 (Lisdexamfetamine dimesylate) Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 4, Double-Blind, Multi-Center, Placebo-Controlled, Randomized Withdrawal, Safety and Efficacy Study of SPD489 in Adults Aged 18-55 With Attention-Deficit/Hyperactivity Disorder (ADHD)|
|Actual Study Start Date :||April 30, 2009|
|Actual Primary Completion Date :||July 8, 2010|
|Actual Study Completion Date :||July 8, 2010|
Drug: SPD489 (Lisdexamfetamine dimesylate)
1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks.
Other Name: Vyvanse
|Placebo Comparator: Placebo||
1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.
- Percent of Treatment Failures at up to 6 Weeks [ Time Frame: Up to 6 weeks ]Treatment failure defined as > or equal to 50% increase in the ADHD-RS with adult prompts total score and a > or equal to 2 point increase in the CGI-S score.
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks [ Time Frame: Up to 6 weeks ]The ADHD-RS consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
- Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks [ Time Frame: Up to 6 weeks ]CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877487
|Study Director:||Study Director||Takeda|