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

Tracking Information

First Received Date ^ICMJE

February 18, 2008

Last Updated Date

May 13, 2009

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00626652 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: K201 Injection

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

June 2009

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Israel, Russian Federation

Administrative Information

NCT ID ^ICMJE

NCT00626652

Responsible Party

Howard C. Dittrich, MD; Chief Medical Officer, Sequel Pharmaceuticals

Study ID Numbers ^ICMJE

CJI-201

Study Sponsor ^ICMJE

Sequel Pharmaceuticals, Inc

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Sequel Pharmaceuticals, Inc

Verification Date

May 2009

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