Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation (RESTORATION)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
K201 Injection
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Restoration of sinus rhythm
Secondary Outcome Measures
Full Information
NCT ID
NCT00626652
First Posted
February 18, 2008
Last Updated
January 7, 2010
Sponsor
Sequel Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT00626652
Brief Title
Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
Acronym
RESTORATION
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sequel Pharmaceuticals, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
K201 Injection
Intervention Description
single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule
Primary Outcome Measure Information:
Title
Restoration of sinus rhythm
Time Frame
24hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey Pavlovich Golitsyn, Prof.
Organizational Affiliation
Russian Cardiologic Scientific and Manufacturing Complex of Roszdrav, Institute of Cardiology n.a. A.L.Myasnikov, Department of clinical electrophysiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amos Katz, Prof.
Organizational Affiliation
Barzilai Medical Center
Official's Role
Principal Investigator
Facility Information:
City
Ashkelon
Country
Israel
City
Beer Sheva
Country
Israel
City
Haifa
Country
Israel
City
Holon
Country
Israel
City
Jerusalem
Country
Israel
City
Nazareth
Country
Israel
City
Safed
Country
Israel
City
Moscow
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
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