ClinicalTrials.gg
TerminatedNCT01067833ARCTIC-AFUpdated May 16, 2011

Phase 2 Study of Oral K201 for Prevention of AF Recurrence

A Phase 2 interventional study of K201 Tablet and Placebo Tablet in Atrial Fibrillation, sponsored by Sequel Pharmaceuticals, Inc. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-16.

Sponsored by Sequel Pharmaceuticals, Inc · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Atrial Fibrillation

Browse trials for

Keywords

  • atrial fibrillation
  • AF
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's planned enrollment of 300 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Sequel Pharmaceuticals, Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo Tablet

  • Experimental
    Dose 1

    K201

    Drug: K201 Tablet

  • Experimental
    Dose 2

    K201

    Drug: K201 Tablet

  • Experimental
    Dose 3

    K201

    Drug: K201 Tablet

Interventions

  • oral tablet, x28 days

  • DrugPlacebo Tablet

    oral tablet, x28 days

06

What researchers measure

Primary outcomes

  1. time to first documented recurrence of symptomatic AF

    Time frame: 28 days

  2. time to first documented recurrence of symptomatic or asymptomatic AF

    Time frame: 28 days

  3. proportion of subjects in sinus rhythm

    Time frame: Day 28

  4. number of AF beats

    Time frame: 10 days

  5. time in AF

    Time frame: 10 days

  6. safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events

    Time frame: 42 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2010, a primary completion of Oct 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2010
First posted
Feb 12, 2010
Start
Apr 2010
Primary completionEst.
Oct 2011
CompletionEst.
Dec 2011
Last update
May 16, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01067833
Lead sponsor
Sequel Pharmaceuticals, Inc
First posted
Feb 12, 2010
Start date
Apr 2010
Primary completion
Oct 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
May 16, 2011

Study contacts

Paul Chamberlin, MD
study director · Sequel Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: K201 compound

Start the discussion