Prevention Of Recurrence Of Atrial Fibrillation

NCT ID: NCT00041496

Last Updated: 2014-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2003-12-31

Brief Summary

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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

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Conditions

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Fibrillation, Atrial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or placebo

Group Type EXPERIMENTAL

SB-207266

Intervention Type DRUG

White, oval, biconvex tablets containing either 10mg, 25mg or 40mg

Arm 2

Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo to match SB-207266

Interventions

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SB-207266

White, oval, biconvex tablets containing either 10mg, 25mg or 40mg

Intervention Type DRUG

Placebo

Placebo to match SB-207266

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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207266082

Identifier Type: -

Identifier Source: org_study_id

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