NCT01151137|TerminatedPhase 3ResultsDMC

Study Stopped

The study was stopped because of safety concerns

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

PALLAS

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

Sanofi ClinicalTrials.gov

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3 other identifiers

EFC114052010-019791-73U1111-1116-5566

Study Type

interventional

Target

3,236

Locations

36 countries

Sites

Timeline

RegisteredJun 2010

StartedJul 2010

CompletionSep 2011

Brief 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 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).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

3,236

participants targeted

Target at P75+ for phase_3 atrial-fibrillation

Timeline

Completed

Started Jul 2010

Shorter than P25 for phase_3 atrial-fibrillation

Geographic Reach

36 countries

36 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

June 22, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed

6 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

October 26, 2012

Completed

Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

1.2 years

First QC Date

June 22, 2010

Results QC Date

September 14, 2012

Last Update Submit

October 23, 2012

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

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.
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.
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.
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Secondary Outcomes (2)

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

Other Outcomes (2)

Overview of Cardiovascular Events
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Overview of Adverse Events [AE]
from first study drug intake up to 10 days after the last study drug intake

Study Arms (2)

Dronedarone

EXPERIMENTAL

Dronedarone 400 mg twice a day until the CSED

Drug: Dronedarone

placebo

PLACEBO COMPARATOR

Placebo (for Dronedarone) twice a day until the CSED

Drug: Placebo (for Dronedarone)

Interventions

DronedaroneDRUG

Film-coated tablet Oral administration under fed conditions (during breakfast and dinner)

Also known as: MULTAQ, SR33589

Dronedarone

Placebo (for Dronedarone)DRUG

film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner)

placebo

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

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:
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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.