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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00626652
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : January 8, 2010
Information provided by:
Sequel Pharmaceuticals, Inc

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: K201 Injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study of the Effects of K201 Injection, 2 mg/mL on the Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
Study Start Date : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: K201 Injection
single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule

Primary Outcome Measures :
  1. Restoration of sinus rhythm [ Time Frame: 24hrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00626652

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Ashkelon, Israel
Beer Sheva, Israel
Haifa, Israel
Holon, Israel
Jerusalem, Israel
Nazareth, Israel
Safed, Israel
Russian Federation
Moscow, Russian Federation
St Petersburg, Russian Federation
Sponsors and Collaborators
Sequel Pharmaceuticals, Inc
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Principal Investigator: Sergey Pavlovich Golitsyn, Prof. Russian Cardiologic Scientific and Manufacturing Complex of Roszdrav, Institute of Cardiology n.a. A.L.Myasnikov, Department of clinical electrophysiology
Principal Investigator: Amos Katz, Prof. Barzilai Medical Center

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Responsible Party: Howard C. Dittrich, MD; Chief Medical Officer, Sequel Pharmaceuticals Identifier: NCT00626652    
Other Study ID Numbers: CJI-201
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: January 8, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes