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

This study has been completed.
Sponsor:
Information provided by:
Sequel Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00626652
First received: February 18, 2008
Last updated: January 7, 2010
Last verified: January 2010
History of Changes

February 18, 2008
January 7, 2010
March 2008
December 2009   (final data collection date for primary outcome measure)
Restoration of sinus rhythm [ Time Frame: 24hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00626652 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
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

To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atrial Fibrillation
Drug: K201 Injection
single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule
Experimental: 1
Intervention: Drug: K201 Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel,   Russian Federation
 
NCT00626652
CJI-201
No
Howard C. Dittrich, MD; Chief Medical Officer, Sequel Pharmaceuticals
Sequel Pharmaceuticals, Inc
Not Provided
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
Sequel Pharmaceuticals, Inc
January 2010

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