Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435221
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-24
Brief Title:
Safety Study of Cytisinicline in Adult Combustible Andor E-cigarette Smokers
Sponsor:
Achieve Life Sciences
Organization:
Achieve Life Sciences
Study Overview
Official Title:
A Multicenter Open-Label Study Assessing Long-Term Exposure with Cytisinicline 3 Mg TID
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORCA-OL
Brief Summary:
Safety assessment of long-term 3 mg cytisinicline three times daily TID exposure for 52 weeks is the main purpose of this study conducted in the United States
Detailed Description:
None
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