Phase 2 Study of Oral K201 for Prevention of AF Recurrence (ARCTIC-AF)

This study has been terminated.
Sponsor:
Information provided by:
Sequel Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01067833
First received: February 10, 2010
Last updated: May 13, 2011
Last verified: May 2011
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Drug: K201 Tablet
Drug: Placebo Tablet
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sequel Pharmaceuticals, Inc:

Primary Outcome Measures:
  • time to first documented recurrence of symptomatic AF [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • time to first documented recurrence of symptomatic or asymptomatic AF [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • proportion of subjects in sinus rhythm [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • number of AF beats [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • time in AF [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo Tablet
oral tablet, x28 days
Experimental: Dose 1
K201
Drug: K201 Tablet
oral tablet, x28 days
Experimental: Dose 2
K201
Drug: K201 Tablet
oral tablet, x28 days
Experimental: Dose 3
K201
Drug: K201 Tablet
oral tablet, x28 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067833

Sponsors and Collaborators
Sequel Pharmaceuticals, Inc
Investigators
Study Director: Paul Chamberlin, MD Sequel Pharmaceuticals
  More Information

No publications provided

Responsible Party: Howard C. Dittrich, CMO, Sequel Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01067833     History of Changes
Other Study ID Numbers: CJO-201
Study First Received: February 10, 2010
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency

Keywords provided by Sequel Pharmaceuticals, Inc:
atrial fibrillation
AF

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on April 16, 2014