Phase 2 Study of Oral K201 for Prevention of AF Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type DRUG

oral tablet, x28 days

Dose 1

K201

Group Type EXPERIMENTAL

K201 Tablet

Intervention Type DRUG

oral tablet, x28 days

Dose 2

K201

Group Type EXPERIMENTAL

K201 Tablet

Intervention Type DRUG

oral tablet, x28 days

Dose 3

K201

Group Type EXPERIMENTAL

K201 Tablet

Intervention Type DRUG

oral tablet, x28 days

Interventions

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K201 Tablet

oral tablet, x28 days

Intervention Type DRUG

Placebo Tablet

oral tablet, x28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Symptomatic AF (sustained \>3 days and \<6 months) and clinically indicated for cardioversion;
* Adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by ACC/AHA/ESC guidelines or with local clinical practice;
* Hemodynamically stable (90 mmHg \< systolic blood pressure \< 190 mmHg)at screening and on Day 1;

Exclusion Criteria

* Known prolonged QT syndrome or QTc interval of \>0.500 sec at screening; familial long QT syndrome; previous Torsade de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT);
* QRS \>0.130 sec;
* Previous episodes of second- or third-degree atrioventricular block;
* Unsuccessful DC cardioversion attempt within 3 months; prior ablation for AF;
* Persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including CRT, AICD);
* Myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
* NYHA Class III or Class IV heart failure (HF) at screening or admission, or hospitalized for HF in previous 6 months;
* Known concurrent temporary secondary causes of AF;
* Received a Class I or Class III antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks;
* Received treatment with other drugs known to prolong the QT interval within 5 half-lives.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No