A multi-center, Randomized, double-blind, placebo-controlled study to Evaluate the Safety and efficacy of a single oral dose of vanoxerine for The conversion Of subjects with REcent onset atrial fibrillation or flutter to normal Sinus Rhythm
Phase 3
Completed
- Conditions
- abnormal heart rhythmatrial fibrillation10007521
- Registration Number
- NL-OMON42537
- Lead Sponsor
- aguna Pharmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
Onset of Atrial fibrillation/Atrial Flutter within the 7 calendar days preceding randomisation, based on symptoms. AF/AFL documented by ECG during the screening period and immediately prior to study drug administration. (see protocol page 30)
Exclusion Criteria
See protocol page 30 and 31
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method