NCT01259622
Terminated
Phase 2
A mulTi-center, Randomized, doUble-bliNded, Placebo-controlled Dose-escalating Study of the Effects of K201 on the RestorAtion of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation of Recent Onset
Overview
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Sequel Pharmaceuticals, Inc
- Enrollment
- 80
- Primary Endpoint
- proportion of subjects who convert to sinus rhythm
Overview
Brief Summary
The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
- •Atrial fibrillation documented by ECG at the start of study drug infusion.
Exclusion Criteria
- •Previous exposure to K201
- •QTcF (Fridericia correction) \>440 ms
- •QRS interval \> 140 ms
- •Paced atrial or paced ventricular rhythm on ECG
- •History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
- •History of amiodarone (oral or IV) in the last 3 months.
- •Clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
- •History of failed electrical cardioversion at any time in the past
- •History of polymorphic ventricular tachycardia (e.g. torsades des pointes)
- •History or family history of Long QT Syndrome
Arms & Interventions
placebo
Placebo Comparator
Intervention: saline (Drug)
K201
Experimental
intravenous K201
Intervention: K201 (Drug)
Outcomes
Primary Outcomes
proportion of subjects who convert to sinus rhythm
Time Frame: 24 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
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