Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-03-09 @ 9:51 AM
Study NCT ID:
NCT01067833
Status:
TERMINATED
Last Update Posted:
2011-05-16
First Post:
2010-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of Oral K201 for Prevention of AF Recurrence
Sponsor:
Sequel Pharmaceuticals, Inc
Organization:
Study Overview
Official Title:
A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary EffiCacy Study of K201 Oral for the Prevention of ATrial FIbrillation (AF) Recurrence in Subjects Post-Conversion From AF
Status:
TERMINATED
Status Verified Date:
2011-05
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:
ARCTIC-AF
Brief Summary:
To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained symptomatic atrial fibrillation (AF duration \>3 days and \<6 months).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: