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

This study is currently recruiting participants.
Verified by Sequel Pharmaceuticals, Inc, August 2008

Sponsored by: Sequel Pharmaceuticals, Inc
Information provided by: Sequel Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00626652
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
Drug: K201 Injection
Phase II

Genetics Home Reference related topics:   Brugada syndrome    familial atrial fibrillation    short QT syndrome   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment
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

Further study details as provided by Sequel Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Restoration of sinus rhythm [ Time Frame: 24hrs ] [ Designated as safety issue: No ]

Estimated Enrollment:   60
Study Start Date:   March 2008
Estimated Study Completion Date:   November 2008
Estimated Primary Completion Date:   October 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: K201 Injection
single intravenous infusion, Dose 1, 2, 3, 4 or placebo

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626652

Contacts
Contact: Howard C Dittrich, MD     858.405.1429     HDittrich@SequelPharma.com    
Contact: Paul Chamberlin, MD     858.523.4515     PChamberlin@SequelPharma.com    

Locations
Israel
Recruiting
      Ashkelon, Israel
Not yet recruiting
      Hadera, Israel
Not yet recruiting
      Holon, Israel
Not yet recruiting
      Jerusalem, Israel
Recruiting
      Nazareth, Israel
Recruiting
      Safed, Israel
Recruiting
      Zeriffin, Israel
Russian Federation
Recruiting
      Moscow, Russian Federation
Recruiting
      St Petersburg, Russian Federation

Sponsors and Collaborators
Sequel Pharmaceuticals, Inc

Investigators
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    
  More Information


Responsible Party:   Sequel Pharmaceuticals ( Howard C. Dittrich, MD; Chief Medical Officer )
Study ID Numbers:   CJI-201
First Received:   February 18, 2008
Last Updated:   August 13, 2008
ClinicalTrials.gov Identifier:   NCT00626652
Health Authority:   Israel: Ministry of Health;   Russia: Ministry of Health and Social Development of the Russian Federation

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 15, 2008




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