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

February 10, 2010
May 13, 2011
April 2010
October 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01067833 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase 2 Study of Oral K201 for Prevention of AF Recurrence
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Atrial Fibrillation
  • Drug: K201 Tablet
    oral tablet, x28 days
  • Drug: Placebo Tablet
    oral tablet, x28 days
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo Tablet
  • Experimental: Dose 1
    K201
    Intervention: Drug: K201 Tablet
  • Experimental: Dose 2
    K201
    Intervention: Drug: K201 Tablet
  • Experimental: Dose 3
    K201
    Intervention: Drug: K201 Tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
December 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01067833
CJO-201
Yes
Howard C. Dittrich, CMO, Sequel Pharmaceuticals, Inc
Sequel Pharmaceuticals, Inc
Not Provided
Study Director: Paul Chamberlin, MD Sequel Pharmaceuticals
Sequel Pharmaceuticals, Inc
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP