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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
Sequel Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 18, 2008
Last Updated
January 7, 2010
Sponsor
Sequel Pharmaceuticals, Inc
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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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