Phase 2 Study of Oral K201 for Prevention of AF Recurrence

Atrial Fibrillation Clinical Trial

— ARCTIC-AF  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01067833
• Other study ID #: CJO-201
• Status: Terminated
• Phase: Phase 2
• First received: February 10, 2010
• Last updated: May 13, 2011
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2011
• Source: Sequel Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencySweden: Medical Products AgencyNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• K201 Tablet
oral tablet, x28 days
• Placebo Tablet
oral tablet, x28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sequel Pharmaceuticals, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to first documented recurrence of symptomatic AF		28 days	No
Primary	time to first documented recurrence of symptomatic or asymptomatic AF		28 days	No
Primary	proportion of subjects in sinus rhythm		Day 28	No
Primary	number of AF beats		10 days	No
Primary	time in AF		10 days	No
Primary	safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events		42 days	Yes