Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04507204
Status:
TERMINATED
Last Update Posted:
2023-07-27
First Post:
2020-07-24
Brief Title:
Real-World Evidence of Duration of Effect of Adhansia XR Extended-Release for Treatment of Attention-DeficitHyperactivity Disorder ADHD
Sponsor:
Purdue Pharma LP
Organization:
Purdue Pharma LP
Study Overview
Official Title:
Real-world Evidence of Duration of Adhansia XR for Treatment of ADHD RE-DAX An Open-label Pragmatic Study to Assess the Real-world Effectiveness of Adhansia XR in Treatment of Adult and Adolescent Patients With ADHD in the United States
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to administrative reasons not related to efficacy or safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RE-DAX
Brief Summary:
The purpose of this study is to investigate the treatment effectiveness of Adhansia XR at month-2 after initiation and the effectiveness of Adhansia XR overall and when compared with the active comparator group Concerta over time
Detailed Description:
This phase IV study is a prospective open-label randomized pragmatic study to investigate the treatment effectiveness of Adhansia XR at Month-2 after initiation and the effectiveness of Adhansia XR overall and when compared with the active comparator group OROS MPH or Concerta over time Additional outcome assessments for both treatment arms include Health-Related Quality of Life HRQoL during the 6-month follow-up period The burden of illness BOI will be investigated by collecting additional measures such as healthcare resource utilization HCRU broader treatment patterns and comorbidities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None