Study of K201 Injection on Restoration of Sinus Rhythm in... | NCT00626652

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

NCT00626652

Sponsor

Sequel Pharmaceuticals, Inc

Status

Completed

Last Update Posted

Jan 8, 2010Estimated

Enrollment

153Actual

Phase

Phase 2

Conditions

Atrial Fibrillation

Interventions

K201 Injection

Countries

Israel
Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Feb 18, 2008

First Submission Date that Met QC Criteria

Feb 20, 2008

First Posted Date

Feb 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2010

Last Update Posted Date

Jan 8, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

153Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: K201 Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
K201 Injection	Drug	single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule	1

Measure	Description	Time Frame
Restoration of sinus rhythm		24hrs

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Ashkelon			Israel

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided