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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
  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 2

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:

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

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

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 of the Russian Federation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013