Fibrillation, AtrialPhase 2NCT00041496

Prevention Of Recurrence Of Atrial Fibrillation

A Phase 2 study testing SB-207266 in people with Fibrillation, Atrial, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Fibrillation, Atrial
What is being tested?: SB-207266
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 520 participants
Where: No sites listed yet
Study dates: Nov 2001to Dec 2003
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

About this study

Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Safety and Efficacy of SB 207266 in Patients With Symptomatic Persistent Atrial Fibrillation (AF)

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).

Conditions: Fibrillation, Atrial
Being tested: SB-207266, Placebo
Keywords: symptomatic atrial fibrillation, persistent atrial fibrillation
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SB-207266Drug
White, oval, biconvex tablets containing either 10mg, 25mg or 40mg
PlaceboOther
Placebo to match SB-207266

Study groups in NCT00041496
Study group	Role	What they receive
Arm 1	Experimental	Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or placebo Receives: Drug: SB-207266
Arm 2	Placebo comparator	Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or Placebo Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-to-first symptomatic AF (atrial fibrillation)
Measured: Up to 26 Weeks

Secondary outcomes (1)

Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion
Measured: Up to 26 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2001Dec 2003

First posted12 Jul 2002 (estimated)
Study startNov 2001
Primary completionDec 2003
Study completionDec 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Fibrillation, AtrialStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 520 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00041496
Sponsor's protocol ID: 207266082
Status last verified: Aug 2014
First submitted: 9 Jul 2002
Last updated: 11 Aug 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Fibrillation, Atrial trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Safety and Efficacy of SB 207266 in Patients With Symptomatic Persistent Atrial Fibrillation (AF)
ClinicalTrials.gov ID: NCT00041496
Acronym / sponsor ID: 207266082
Conditions: Fibrillation, Atrial
Keywords: symptomatic atrial fibrillation, persistent atrial fibrillation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 520 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2001
Primary completion: Dec 2003 (actual)
Study completion: Dec 2003 (actual)
First posted: 12 Jul 2002 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Drug: SB-207266Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or placebo
Arm 2	Placebo comparator	Other: PlaceboPatients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SB-207266White, oval, biconvex tablets containing either 10mg, 25mg or 40mg	Drug	Arm 1
PlaceboPlacebo to match SB-207266	Other	Arm 2

Primary outcome

Time-to-first symptomatic AF (atrial fibrillation)
Time frame: Up to 26 Weeks

1 secondary outcome

Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion
Time frame: Up to 26 Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.

Related trials for Fibrillation, Atrial

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SB-207266 in people with Fibrillation, Atrial, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-to-first symptomatic AF (atrial fibrillation) (time frame: Up to 26 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00041496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2014.