Prevention Of Recurrence Of Atrial Fibrillation | NCT00041496

Studies
Prevention Of Recurrence Of Atrial Fibrillation

NCT00041496

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Aug 11, 2014Estimated

Enrollment

520Actual

Phase

Phase 2

Conditions

Fibrillation, Atrial

Interventions

SB-207266
Placebo

Countries

Not provided

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

Aug 2014

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

Nov 2001

Primary Completion Date

Dec 2003Actual

Completion Date

Dec 2003Actual

First Submitted Date

Jul 9, 2002

First Submission Date that Met QC Criteria

Jul 11, 2002

First Posted Date

Jul 12, 2002Estimated

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

Aug 7, 2014

Last Update Posted Date

Aug 11, 2014Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether the study drug is effective in preventing the recurrence of atrial fibrillation (an abnormal heart rhythm).

Detailed Description

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

520Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or placebo	Drug: SB-207266
Arm 2	Placebo Comparator	Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or Placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SB-207266	Drug	White, oval, biconvex tablets containing either 10mg, 25mg or 40mg	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time-to-first symptomatic AF (atrial fibrillation)		Up to 26 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion		Up to 26 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic persistent atrial fibrillation requiring DC cardioversion.
Duration of AF >48 hrs. <6 months

Exclusion Criteria:

Concomitant Class I and/or III anti-arrhythmic drugs.
Amiodarone treatment within 3 months of the study.
Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

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

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

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

Intervention Browse Module

MeSH Terms

ID	Term
C096919	SB 207266

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided