Atrial FibrillationPhase 3PALLASNCT01151137

Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy

A Phase 3 study testing Dronedarone in people with Atrial Fibrillation, run by Sanofi at 37 sites in 37 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Primary Objective: Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional… Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Dronedarone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,236 participants
Where: 37 sitesin 37 countries
Study dates: Jul 2010to Sep 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Permanent AF defined by the presence of all of the following criteria:
Availability of one 12-lead ECG not more than 14 days prior to randomization showing that the patient is in AF or atrial flutter;
Availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in AF or atrial flutter at least 6 months prior to randomization;
No evidence of sinus rhythm in the period between these two documentations of AF;
Decision of the patient and physician to allow AF to continue without further efforts to restore sinus rhythm.
At least one of the following risk criteria:

Show all 12Show fewer

Coronary artery disease;
Prior stroke or Transient Ischemic Attack [TIA];
Symptomatic heart failure;
Left ventricular ejection fraction [LVEF] less or equal to 0.40;
Peripheral arterial occlusive disease;
Aged 75 years or older with both hypertension and diabetes mellitus.

Who cannot join

Paroxysmal AF;
Persistent AF without a decision to allow AF to continue without further efforts to restore sinus rhythm;
Heart failure of New-York Heart Association [NYHA] class IV or recent unstable NYHA class III.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

37 sites in 37 countries.

Country

City, postcode or hospital

37 sites in 37 countries

United States1 site

Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807

Other trials in United States

Argentina1 site

Sanofi-Aventis Administrative Office
Buenos Aires

Other trials in Argentina

Australia1 site

Sanofi-Aventis Administrative Office
Macquarie Park

Other trials in Australia

Austria1 site

Sanofi-Aventis Administrative Office
Vienna

Other trials in Austria

Belgium1 site

Sanofi-Aventis Administrative Office
Diegem

Other trials in Belgium

Brazil1 site

Sanofi-Aventis Administrative Office
São Paulo

Other trials in Brazil

Bulgaria1 site

Sanofi-Aventis Administrative Office
Sofia

Other trials in Bulgaria

Canada1 site

Sanofi-Aventis Administrative Office
Laval

Other trials in Canada

Chile1 site

Sanofi-Aventis Administrative Office
Providencia Santiago

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Czechia1 site

Sanofi-Aventis Administrative Office
Prague

Other trials in Czechia

Denmark1 site

Sanofi-Aventis Administrative Office
Hørsholm

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Finland1 site

Sanofi-Aventis Administrative Office
Helsinki

Other trials in Finland

France1 site

Sanofi-Aventis Administrative Office
Paris

Other trials in France

Germany1 site

Sanofi-Aventis Administrative Office
Frankfurt

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Greece1 site

Sanofi-Aventis Administrative Office
Kallithea

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Hong Kong1 site

Sanofi-Aventis Administrative Office
Hong Kong

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Hungary1 site

Sanofi-Aventis Administrative Office
Budapest

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Israel1 site

Sanofi-Aventis Administrative Office
Netanya

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Italy1 site

Sanofi-Aventis Administrative Office
Milan

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Malaysia1 site

Sanofi-Aventis Administrative Office
Kuala Lumpur

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Mexico1 site

Sanofi-Aventis Administrative Office
Col. Coyoacan

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Netherlands1 site

Sanofi-Aventis Administrative Office
Gouda

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New Zealand1 site

Sanofi-Aventis Administrative Office
Auckland

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Norway1 site

Sanofi-Aventis Administrative Office
Lysaker

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Poland1 site

Sanofi-Aventis Administrative Office
Warsaw

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Romania1 site

Sanofi-Aventis Administrative Office
Bucharest

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Russia1 site

Sanofi-Aventis Administrative Office
Moscow

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Singapore1 site

Sanofi-Aventis Administrative Office
Singapore

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Slovakia1 site

Sanofi-Aventis Administrative Office
Bratislava

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South Africa1 site

Sanofi-Aventis Administrative Office
Gauteng

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South Korea1 site

Sanofi-Aventis Administrative Office
Seoul

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Spain1 site

Sanofi-Aventis Administrative Office
Barcelona

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Sweden1 site

Sanofi-Aventis Administrative Office
Bromma

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Switzerland1 site

Sanofi-Aventis Administrative Office
Geneva

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Taiwan1 site

Sanofi-Aventis Administrative Office
Taipei

Other trials in Taiwan

Ukraine1 site

Sanofi-Aventis Administrative Office
Kiev

Other trials in Ukraine

United Kingdom1 site

Sanofi-Aventis Administrative Office
Guildford Surrey

Other trials in United Kingdom

About this study

Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Trial for Assessing the Clinical Benefit of Dronedarone 400mg BID on Top of Standard Therapy in Patients With Permanent Atrial Fibrillation and Additional Risk Factors

Primary Objective:

Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors

Secondary Objective:

Demonstrate the efficacy of Dronedarone in preventing cardiovascular death

This was an event-driven study where a common study end date [CSED] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).

Read the detailed description

The study period per participant was variable depending on the enrollment in the study.

A final follow-up visit had to occur within 1 month after the CSED.

Conditions: Atrial Fibrillation
Being tested: Dronedarone, Placebo (for Dronedarone)
Medical subject headings: Atrial Fibrillation

What participants receive

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

DronedaroneDrug
Also called MULTAQ, SR33589
Film-coated tablet
Oral administration under fed conditions (during breakfast and dinner)
Placebo (for Dronedarone)Drug
film-coated tablet strictly identical in appearance
Oral administration under fed conditions (during breakfast and dinner)

Study groups in NCT01151137
Study group	Role	What they receive
Dronedarone	Experimental	Dronedarone 400 mg twice a day until the CSED Receives: Drug: Dronedarone
placebo	Placebo comparator	Placebo (for Dronedarone) twice a day until the CSED Receives: Drug: Placebo (for Dronedarone)

What is being measured

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

Overview of the Two Co-primary Outcomes
First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions [MI], or cardiovascular death.
Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause.
Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks [TIA], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause.
Measured: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Time to First Co-primary Outcome (Cumulative Incidence Function)
Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death.
Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.
95% confidence interval was computed at each time-point using Greenwood's variance estimation.
Measured: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Time to Second Co-primary Outcome (Cumulative Incidence Function)
Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause.
Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.
95% confidence interval was computed at each time-point using Greenwood's variance estimation.
Measured: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Secondary outcomes (2)

Deaths
Deaths were classified according to the primary cause of death.
Measured: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Time to Cardiovascular Death (Cumulative Incidence Function)
Time to cardiovascular death was defined as the time from randomization to the death.
Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.
95% confidence interval was computed at each time-point using Greenwood's variance estimation.
Measured: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Timeline

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

Jul 2010Sep 2011

First posted25 Jun 2010 (estimated)
Study startJul 2010
Primary completionSep 2011
Study completionSep 2011

Why it stopped: The study was stopped because of safety concerns

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by SanofiThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 3,236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01151137
Sponsor's protocol ID: EFC11405
Other IDs: 2010-019791-73, U1111-1116-5566
Acronym: PALLAS
Status last verified: Oct 2012
First submitted: 22 Jun 2010
Last updated: 26 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, Atar D, Avezum A, Blomstrom P, Borggrefe M, Budaj A, Chen SA, Ching CK, Commerford P, Dans A, Davy JM, Delacretaz E, Di Pasquale G, Diaz R, Dorian P, Flaker G, Golitsyn S, Gonzalez-Hermosillo A, Granger CB, Heidbuchel H, Kautzner J, Kim JS, Lanas F, Lewis BS, Merino JL, Morillo C, Murin J, Narasimhan C, Paolasso E, Parkhomenko A, Peters NS, Sim KH, Stiles MK, Tanomsup S, Toivonen L, Tomcsanyi J, Torp-Pedersen C, Tse HF, Vardas P, Vinereanu D, Xavier D, Zhu J, Zhu JR, Baret-Cormel L, Weinling E, Staiger C, Yusuf S, Chrolavicius S, Afzal R, Hohnloser SH; PALLAS Investigators. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011 Dec 15;365(24):2268-76. doi: 10.1056/NEJMoa1109867. Epub 2011 Nov 14.
PubMed 22082198
Hohnloser SH, Halperin JL, Camm AJ, Gao P, Radzik D, Connolly SJ; PALLAS investigators. Interaction between digoxin and dronedarone in the PALLAS trial. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1019-25. doi: 10.1161/CIRCEP.114.002046. Epub 2014 Nov 6.
PubMed 25378467

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?

See locations

RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Trial for Assessing the Clinical Benefit of Dronedarone 400mg BID on Top of Standard Therapy in Patients With Permanent Atrial Fibrillation and Additional Risk Factors
ClinicalTrials.gov ID: NCT01151137
Acronym / sponsor ID: PALLAS / EFC11405
Conditions: Atrial Fibrillation
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was stopped because of safety concerns
Enrolment: 3,236 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 25 Jun 2010 (estimated)
Results: Posted 26 Oct 2012

Clinical summary

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

Primary Objective:

Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors

Secondary Objective:

Demonstrate the efficacy of Dronedarone in preventing cardiovascular death

Detailed description

The study period per participant was variable depending on the enrollment in the study.

A final follow-up visit had to occur within 1 month after the CSED.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dronedarone	Experimental	Drug: DronedaroneDronedarone 400 mg twice a day until the CSED
placebo	Placebo comparator	Drug: Placebo (for Dronedarone)Placebo (for Dronedarone) twice a day until the CSED

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (12 listed)

Permanent AF defined by the presence of all of the following criteria:
At least one of the following risk criteria:

Key exclusion criteria (4 listed)

Paroxysmal AF;
Persistent AF without a decision to allow AF to continue without further efforts to restore sinus rhythm;
Heart failure of New-York Heart Association [NYHA] class IV or recent unstable NYHA class III.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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
DronedaroneAlso: MULTAQ, SR33589Film-coated tablet Oral administration under fed conditions (during breakfast and dinner)	Drug	Dronedarone
Placebo (for Dronedarone)film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner)	Drug	placebo

Primary outcome

Overview of the Two Co-primary Outcomes
Time frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions [MI], or cardiovascular death. Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause. Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks [TIA], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause.
Time to First Co-primary Outcome (Cumulative Incidence Function)
Time frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation.
Time to Second Co-primary Outcome (Cumulative Incidence Function)
Time frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation.

2 secondary outcomes

Deaths
Time frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Time to Cardiovascular Death (Cumulative Incidence Function)
Time frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Results and safety

Results posted to the registry on 26 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	1,617	1,601
Dronedarone	1,619	1,591

Primary outcome: Overview of the Two Co-primary Outcomes

Time frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year). Number. Unit: participants

Measure	Placebo n = 1617	Dronedarone n = 1619
First co-primary endpoint	19	43
Second co-primary endpoint	67	127

Population analysed: Intent-to-treat population: All randomized participants considered in the treatment group to which they were randomized regardless of the treatment they actually received

Primary outcome: Time to First Co-primary Outcome (Cumulative Incidence Function)

Time frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year). Number (95% Confidence Interval). Unit: proportion of participants

Measure	Placebo n = 1617	Dronedarone n = 1619
Cumulative incidence at 14 days	0.002 (0.000 to 0.004)	0.009 (0.005 to 0.014)
Cumulative incidence at 30 days	0.003 (0.000 to 0.006)	0.013 (0.008 to 0.019)
Cumulative incidence at 90 days	0.007 (0.003 to 0.012)	0.021 (0.014 to 0.029)
Cumulative incidence at 180 days	0.013 (0.006 to 0.021)	0.042 (0.028 to 0.056)
Cumulative incidence at 270 days	0.038 (0.012 to 0.064)	0.045 (0.030 to 0.061)
Cumulative incidence at 360 days	0.038 (0.012 to 0.064)	0.045 (0.030 to 0.061)

Placebo vs Dronedarone: Hazard Ratio (HR): 2.294 (95% CI 1.337 to 3.936), p = 0.0019, Log Rank

Population analysed: Intent-to-treat population as previously defined

Primary outcome: Time to Second Co-primary Outcome (Cumulative Incidence Function)

Time frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year). Number (95% Confidence Interval). Unit: proportion of participants

Measure	Placebo n = 1617	Dronedarone n = 1619
Cumulative incidence at 14 days	0.005 (0.002 to 0.008)	0.020 (0.013 to 0.027)
Cumulative incidence at 30 days	0.014 (0.008 to 0.020)	0.034 (0.025 to 0.043)
Cumulative incidence at 90 days	0.033 (0.023 to 0.042)	0.069 (0.055 to 0.083)
Cumulative incidence at 180 days	0.059 (0.043 to 0.075)	0.110 (0.089 to 0.130)
Cumulative incidence at 270 days	0.099 (0.062 to 0.137)	0.137 (0.107 to 0.167)
Cumulative incidence at 360 days	0.099 (0.062 to 0.137)	0.137 (0.107 to 0.167)

Placebo vs Dronedarone: Hazard Ratio (HR): 1.947 (95% CI 1.448 to 2.617), p <0.0001, Log Rank

Population analysed: Intent-to-treat population as previously defined

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	77 of 1,609 (4.8%)	38 of 1,609 (2.4%)	Not reported
Dronedarone	113 of 1,614 (7%)	100 of 1,614 (6.2%)	Not reported

Limitations and caveats (from the sponsor): Given that the study was prematurely discontinued after 3236 patients were randomized (30% of the initial planned number), p-values were provided for information without any adjustment for multiplicity.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22082198Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, Atar D, Avezum A, Blomstrom P, Borggrefe M, Budaj A, Chen SA, Ching CK, Commerford P, Dans A, Davy JM, Delacretaz E, Di Pasquale G, Diaz R, Dorian P, Flaker G, Golitsyn S, Gonzalez-Hermosillo A, Granger CB, Heidbuchel H, Kautzner J, Kim JS, Lanas F, Lewis BS, Merino JL, Morillo C, Murin J, Narasimhan C, Paolasso E, Parkhomenko A, Peters NS, Sim KH, Stiles MK, Tanomsup S, Toivonen L, Tomcsanyi J, Torp-Pedersen C, Tse HF, Vardas P, Vinereanu D, Xavier D, Zhu J, Zhu JR, Baret-Cormel L, Weinling E, Staiger C, Yusuf S, Chrolavicius S, Afzal R, Hohnloser SH; PALLAS Investigators. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011 Dec 15;365(24):2268-76. doi: 10.1056/NEJMoa1109867. Epub 2011 Nov 14.
Derived from this study: PubMed 25378467Hohnloser SH, Halperin JL, Camm AJ, Gao P, Radzik D, Connolly SJ; PALLAS investigators. Interaction between digoxin and dronedarone in the PALLAS trial. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1019-25. doi: 10.1161/CIRCEP.114.002046. Epub 2014 Nov 6.

Related trials for Atrial Fibrillation

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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, 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.

Clinical Sciences & Operations study director

Sanofi

37 sites in 37 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dronedarone in people with Atrial Fibrillation, run by Sanofi at 37 sites in 37 countries.

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 12 inclusion and 4 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: stopped early, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Argentina, Australia, Austria, Belgium and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overview of the Two Co-primary Outcomes (time frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)). The study lists 3 primary outcomes in all. 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 NCT01151137, which also lists 2 linked publications.

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 26 Oct 2012.