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A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation (ATHENA)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174785
First received: September 13, 2005
Last updated: January 5, 2010
Last verified: January 2010
Results First Received: July 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Atrial Fibrillation
Atrial Flutter
Interventions: Drug: dronedarone (SR33589)
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment of patients started on June 29, 2005 and was completed on December 30, 2006. The study was conducted at 551 centers in 37 countries. The common study end date ensuring a minimum planned follow-up of one year was December 30th, 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dronedarone 400mg Bid dronedarone tablets 400mg twice daily
Placebo matching placebo tablets

Participant Flow:   Overall Study
    Dronedarone 400mg Bid   Placebo
STARTED   2301 [1]   2327 [2] 
COMPLETED   1605 [3]   1611 [3] 
NOT COMPLETED   696   716 
Adverse Event                293                191 
Protocol Violation                14                14 
Withdrawal by Subject                173                175 
Atrial Fibrillation/Flutter recurrence                110                167 
Prohibited antiarrhythmic medication                39                88 
Other prohibited medication                5                3 
Family request                6                8 
Not pre-specified/Not coded                56                70 
[1] randomized patients; among them, 10 patients did not receive any study drug in the dronedarone group
[2] randomized patients; among them, 14 patients did not receive any study drug in the placebo group
[3] completed study drug



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dronedarone 400mg Bid dronedarone tablets 400mg twice daily
Placebo matching placebo tablets
Total Total of all reporting groups

Baseline Measures
   Dronedarone 400mg Bid   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 2301   2327   4628 
Age, Customized 
[Units: Participants]
     
18 to < 65 years   431   442   873 
65 to < 75 years   923   907   1830 
>= 75 years   947   978   1925 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.6  (8.9)   71.7  (9.0)   71.6  (9.0) 
Gender 
[Units: Participants]
     
Female   1131   1038   2169 
Male   1170   1289   2459 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   First Hospitalization for Cardiovascular Reason or Death From Any Cause   [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]

2.  Secondary:   Death From Any Cause   [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]

3.  Secondary:   First Hospitalization for Cardiovascular Reason   [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]

4.  Secondary:   Cardiovascular Death   [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]

5.  Other Pre-specified:   Adjudicated Cardiovascular Death   [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Additional Description Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Dronedarone 400mg Bid dronedarone tablets 400mg twice daily
Placebo matching placebo tablets

Other Adverse Events
    Dronedarone 400mg Bid   Placebo
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   1584/2291 (69.14%)   1527/2313 (66.02%) 
Cardiac disorders     
Any cardiac disorders * 1     
# participants affected / at risk   251/2291 (10.96%)   213/2313 (9.21%) 
Gastrointestinal disorders     
Any Gastrointestinal disorders * 1     
# participants affected / at risk   573/2291 (25.01%)   478/2313 (20.67%) 
Diarrhoea * 1     
# participants affected / at risk   222/2291 (9.69%)   142/2313 (6.14%) 
Nausea * 1     
# participants affected / at risk   122/2291 (5.33%)   71/2313 (3.07%) 
General disorders     
Any general disorders and administration site conditions * 1     
# participants affected / at risk   397/2291 (17.33%)   348/2313 (15.05%) 
Oedema peripheral * 1     
# participants affected / at risk   147/2291 (6.42%)   119/2313 (5.14%) 
Fatigue * 1     
# participants affected / at risk   115/2291 (5.02%)   90/2313 (3.89%) 
Infections and infestations     
Any infections and infestations * 1     
# participants affected / at risk   508/2291 (22.17%)   533/2313 (23.04%) 
Injury, poisoning and procedural complications     
Any injury, poisoning and procedural complications * 1     
# participants affected / at risk   187/2291 (8.16%)   198/2313 (8.56%) 
Investigations     
Any investigation disorders * 1     
# participants affected / at risk   298/2291 (13.01%)   199/2313 (8.60%) 
Metabolism and nutrition disorders     
Any metabolism and nutrition disorders * 1     
# participants affected / at risk   171/2291 (7.46%)   183/2313 (7.91%) 
Musculoskeletal and connective tissue disorders     
Any musculoskeletal and connective tissue disorders * 1     
# participants affected / at risk   364/2291 (15.89%)   376/2313 (16.26%) 
Nervous system disorders     
Any nervous system disorders * 1     
# participants affected / at risk   362/2291 (15.80%)   365/2313 (15.78%) 
Dizziness * 1     
# participants affected / at risk   160/2291 (6.98%)   145/2313 (6.27%) 
Psychiatric disorders     
Any psychiatric disorders * 1     
# participants affected / at risk   106/2291 (4.63%)   125/2313 (5.40%) 
Respiratory, thoracic and mediastinal disorders     
Any respiratory, thoracic and mediastinal disorders * 1     
# participants affected / at risk   315/2291 (13.75%)   318/2313 (13.75%) 
Dyspnoea * 1     
# participants affected / at risk   120/2291 (5.24%)   96/2313 (4.15%) 
Skin and subcutaneous tissue disorders     
Any skin and subcutaneous tissue disorders * 1     
# participants affected / at risk   235/2291 (10.26%)   174/2313 (7.52%) 
Vascular disorders     
Any vascular disorders * 1     
# participants affected / at risk   179/2291 (7.81%)   187/2313 (8.08%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (10.1)



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information