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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Disease Attributes
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014