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CompletedNCT00626652RESTORATIONUpdated Jan 8, 2010

Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation

A Phase 2 interventional study of K201 Injection in Atrial Fibrillation, sponsored by Sequel Pharmaceuticals, Inc. Completed at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-08.

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

Phase
Phase 2
Study type
Interventional
Enrollment
153
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.

This study's enrollment of 153 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Sequel Pharmaceuticals, Inc is the lead sponsor of 2 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

Inclusion criteria

  • Symptomatic atrial fibrillation
  • Atrial fibrillation documented by ECG
  • Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.

Exclusion criteria

Exclusion Criteria:

  • Systolic blood pressure \<100 mmHg
  • Heart rate \<50 bpm
  • Temperature >38°C
  • QT or QTcB >440 ms
  • QRS >140 ms
  • Paced atrial or ventricular rhythm on ECG
  • Serum potassium \<3.5 meq/L
  • History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
  • History of amiodarone in last 6 months.
  • Clinical evidence of acute coronary syndrome
  • Acute pulmonary edema or embolism
  • Hyperthyroidism
  • Acute pericarditis
  • History of failed electrical cardioversion at any time
  • History of torsades des pointes
  • History of familial long QT interval syndrome
  • History of ventricular tachycardia requiring drug or device therapy
  • History of NYHA Heart Failure Class 3 or 4.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
153 participants (actual)

Study arms

  • Experimental
    1

    Drug: K201 Injection

Interventions

  • DrugK201 Injection

    single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule

06

What researchers measure

Primary outcomes

  1. Restoration of sinus rhythm

    Time frame: 24hrs

07

Study locations

9 sites
  • Ashkelon, Israel
  • Beer Sheva, Israel
  • Haifa, Israel
  • Holon, Israel
  • Jerusalem, Israel
  • Nazareth, Israel
  • Safed, Israel
  • Moscow, Russian Federation
  • St Petersburg, Russian Federation
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00626652
Lead sponsor
Sequel Pharmaceuticals, Inc
First posted
Feb 29, 2008
Start date
Mar 2008
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Jan 8, 2010

Study contacts

Sergey Pavlovich Golitsyn, Prof.
principal investigator · Russian Cardiologic Scientific and Manufacturing Complex of Roszdrav, Institute of Cardiology n.a. A.L.Myasnikov, Department of clinical electrophysiology
Amos Katz, Prof.
principal investigator · Barzilai Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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