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

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

This study has been completed.

First Received on February 18, 2008. Last Updated on January 7, 2010 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Sequel Pharmaceuticals, Inc:

Primary Outcome Measures:

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

Enrollment:	153
Study Start Date:	March 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: K201 Injection single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule

Eligibility

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

Locations

Israel

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

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

No publications provided

Responsible Party:	Howard C. Dittrich, MD; Chief Medical Officer, Sequel Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00626652 History of Changes
Other Study ID Numbers:	CJI-201
Study First Received:	February 18, 2008
Last Updated:	January 7, 2010
Health Authority:	Israel: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012