Phase 2 Study of Oral K201 for Prevention of AF Recurrence

Phase 2

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Drug: K201 Tablet; Drug: Placebo Tablet

• Registration Number: NCT01067833
• Lead Sponsor: Sequel Pharmaceuticals, Inc

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

Not available

Study Timeline

• Study First Submitted: 2010-02-10
• Study First Submitted QC: 2010-02-10
• Study First Posted: 2010-02-12
• Study Start: 2010-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-13
• Last Update Posted: 2011-05-16
• Primary Completion: 2011-10
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1	K201 Tablet	K201
Dose 2	K201 Tablet	K201
Placebo	Placebo Tablet	Placebo
Dose 3	K201 Tablet	K201

Primary Outcome Measures

Name	Time	Method
time to first documented recurrence of symptomatic AF	28 days
proportion of subjects in sinus rhythm	Day 28
time to first documented recurrence of symptomatic or asymptomatic AF	28 days
number of AF beats	10 days
time in AF	10 days
safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events	42 days