Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death
- Conditions
- Arrhythmia ProphylaxisVentricular Arrhythmia
- Interventions
- Registration Number
- NCT00993382
- Lead Sponsor
- Sanofi
- Brief Summary
The Primary objective was to assess the efficacy of Celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death.
Secondary objectives were:
* To assess the tolerability and safety of the different dose regimens of Celivarone in the selected population.
* To document Celivarone plasma levels during the study.
- Detailed Description
The study included a one week screening period, followed by a treatment period ranging between 6 and 19 months.
The treatment was to be continued until the End of Treatment visit scheduled 10-15 days prior to the common Scheduled Study End Date (SSED). The SSED was defined as about 190 days after the last patient randomization date.
The expected recruitment duration was about 14 months and thus the total duration of the study about 20 months. Visits were planned to be performed at baseline, after 5 days, after 14 days, every month for 6 months and then, every three months after 6 months until the end of the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 486
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Celivarone 50 mg Matching placebo Celivarone, 50 mg once daily up to 10-15 days before the common study end date Celivarone 100 mg Celivarone Celivarone, 100 mg once daily up to 10-15 days before the common study end date Celivarone 100 mg Matching placebo Celivarone, 100 mg once daily up to 10-15 days before the common study end date Celivarone 300 mg Celivarone Celivarone, 300 mg once daily up to 10-15 days before the common study end date Celivarone 300 mg Matching placebo Celivarone, 300 mg once daily up to 10-15 days before the common study end date Amiodarone Matching placebo Amiodarone, 600 mg once daily for 10 days (loading dose) then 200 mg once daily up to 10-15 days before the common study end date Celivarone 50 mg Celivarone Celivarone, 50 mg once daily up to 10-15 days before the common study end date Placebo Matching placebo Matching placebo once daily up to 10-15 days before the common study end date Amiodarone Amiodarone Amiodarone, 600 mg once daily for 10 days (loading dose) then 200 mg once daily up to 10-15 days before the common study end date
- Primary Outcome Measures
Name Time Method Time to Ventricular Tachycardia or Ventricular Fibrillation (VT/VF) triggered ICD interventions or sudden death up to 20 months (median follow-up of 12 months) The presence of VT or VF was documented by ICD interrogation leading to any ICD interventions (shocks or anti-tachycardia pacing).
The 10 first ICD interventions for each patient were centrally and blindly adjudicated by an Adjudication Committee.
- Secondary Outcome Measures
Name Time Method Time to ICD shocks (appropriate or inappropriate) or death from any cause up to 20 months (median follow-up of 12 months) Time to Cardiovascular hospitalization or death up to 20 months (median follow-up of 12 months)
Trial Locations
- Locations (151)
Investigational Site Number 840045
🇺🇸Chicago, Illinois, United States
Investigational Site Number 276005
🇩🇪Bad Neustadt, Germany
Investigational Site Number 036003
🇦🇺Woolloongabba, Australia
Investigational Site Number 840017
🇺🇸Kansas City, Kansas, United States
Investigational Site Number 208005
🇩🇰København Ø, Denmark
Investigational Site Number 348003
🇭🇺Zalaegerszeg, Hungary
Investigational Site Number 616002
🇵🇱Szczecin, Poland
Investigational Site Number 620005
🇵🇹Vila Nova De Gaia, Portugal
Investigational Site Number 703002
🇸🇰Kosice, Slovakia
Investigational Site Number 840042
🇺🇸Mobile, Alabama, United States
Investigational Site Number 643008
🇷🇺Samara, Russian Federation
Investigational Site Number 840032
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 840006
🇺🇸Huntsville, Alabama, United States
Investigational Site Number 840014
🇺🇸Mesa, Arizona, United States
Investigational Site Number 840033
🇺🇸Tucson, Arizona, United States
Investigational Site Number 840054
🇺🇸Redondo Beach, California, United States
Investigational Site Number 840039
🇺🇸Colorado Springs, Colorado, United States
Investigational Site Number 840007
🇺🇸Redwood City, California, United States
Investigational Site Number 840010
🇺🇸Orlando, Florida, United States
Investigational Site Number 840002
🇺🇸Fort Myers, Florida, United States
Investigational Site Number 840005
🇺🇸Port Charlotte, Florida, United States
Investigational Site Number 840013
🇺🇸St. Petersburg, Florida, United States
Investigational Site Number 840004
🇺🇸Augusta, Georgia, United States
Investigational Site Number 840043
🇺🇸St. Petersburg, Florida, United States
Investigational Site Number 840022
🇺🇸Scarborough, Maine, United States
Investigational Site Number 840009
🇺🇸Ann Arbor, Michigan, United States
Investigational Site Number 840035
🇺🇸Lombard, Illinois, United States
Investigational Site Number 840026
🇺🇸Detroit, Michigan, United States
Investigational Site Number 840003
🇺🇸Petoskey, Michigan, United States
Investigational Site Number 840015
🇺🇸Ypsilanti, Michigan, United States
Investigational Site Number 840049
🇺🇸Columbia, Missouri, United States
Investigational Site Number 840019
🇺🇸Kansas City, Missouri, United States
Investigational Site Number 840029
🇺🇸Tulsa, Oklahoma, United States
Investigational Site Number 840031
🇺🇸New York, New York, United States
Investigational Site Number 840037
🇺🇸Portland, Oregon, United States
Investigational Site Number 840024
🇺🇸Camp Hill, Pennsylvania, United States
Investigational Site Number 840034
🇺🇸Upland, Pennsylvania, United States
Investigational Site Number 840030
🇺🇸Doylestown, Pennsylvania, United States
Investigational Site Number 840020
🇺🇸Charleston, South Carolina, United States
Investigational Site Number 840011
🇺🇸Tullahoma, Tennessee, United States
Investigational Site Number 840012
🇺🇸Norfolk, Virginia, United States
Investigational Site Number 840025
🇺🇸Chesapeake, Virginia, United States
Investigational Site Number 840038
🇺🇸Richmond, Virginia, United States
Investigational Site Number 840016
🇺🇸Spokane, Washington, United States
Investigational Site Number 032003
🇦🇷Corrientes, Argentina
Investigational Site Number 032002
🇦🇷Ciudad Autonoma De Bs.As, Argentina
Investigational Site Number 036012
🇦🇺Adelaide, Australia
Investigational Site Number 036006
🇦🇺Auchenflower, Australia
Investigational Site Number 032004
🇦🇷San Miguel De Tucuman, Argentina
Investigational Site Number 036014
🇦🇺Camperdown, Australia
Investigational Site Number 036004
🇦🇺Bedford Park, Australia
Investigational Site Number 036013
🇦🇺Garran, Australia
Investigational Site Number 036008
🇦🇺Nedlands, Australia
Investigational Site Number 036010
🇦🇺Gosford, Australia
Investigational Site Number 036009
🇦🇺New Lambton, Australia
Investigational Site Number 036007
🇦🇺Perth, Australia
Investigational Site Number 056005
🇧🇪Aalst, Belgium
Investigational Site Number 056007
🇧🇪Brugge, Belgium
Investigational Site Number 056002
🇧🇪Gilly, Belgium
Investigational Site Number 056001
🇧🇪Brussel, Belgium
Investigational Site Number 056004
🇧🇪Hasselt, Belgium
Investigational Site Number 056003
🇧🇪Roeselare, Belgium
Investigational Site Number 124009
🇨🇦Calgary, Canada
Investigational Site Number 124010
🇨🇦Hamilton, Canada
Investigational Site Number 124004
🇨🇦London, Canada
Investigational Site Number 124008
🇨🇦Montreal, Canada
Investigational Site Number 124001
🇨🇦Montreal, Canada
Investigational Site Number 124005
🇨🇦Ste-Foy, Canada
Investigational Site Number 124002
🇨🇦Toronto, Canada
Investigational Site Number 124006
🇨🇦Vancouver, Canada
Investigational Site Number 152001
🇨🇱Santiago, Chile
Investigational Site Number 124007
🇨🇦Victoria, Canada
Investigational Site Number 203005
🇨🇿Hradec Kralove, Czech Republic
Investigational Site Number 203004
🇨🇿Brno, Czech Republic
Investigational Site Number 203002
🇨🇿Ceske Budejovice, Czech Republic
Investigational Site Number 203001
🇨🇿Liberec, Czech Republic
Investigational Site Number 203006
🇨🇿Praha 5, Czech Republic
Investigational Site Number 203003
🇨🇿Olomouc, Czech Republic
Investigational Site Number 208002
🇩🇰Aarhus, Denmark
Investigational Site Number 208004
🇩🇰Hellerup, Denmark
Investigational Site Number 246001
🇫🇮Helsinki, Finland
Investigational Site Number 208001
🇩🇰Odense C, Denmark
Investigational Site Number 250002
🇫🇷Montpellier, France
Investigational Site Number 246004
🇫🇮Tampere, Finland
Investigational Site Number 250006
🇫🇷Grenoble, France
Investigational Site Number 250004
🇫🇷Brest, France
Investigational Site Number 250005
🇫🇷Lille, France
Investigational Site Number 250001
🇫🇷Paris Cedex 15, France
Investigational Site Number 250007
🇫🇷Rennes, France
Investigational Site Number 380008
🇮🇹Bergamo, Italy
Investigational Site Number 250003
🇫🇷Vandoeuvre Les Nancy Cedex, France
Investigational Site Number 276003
🇩🇪Dresden, Germany
Investigational Site Number 276002
🇩🇪Bernau, Germany
Investigational Site Number 276001
🇩🇪Frankfurt Am Main, Germany
Investigational Site Number 348001
🇭🇺Balatonfüred, Hungary
Investigational Site Number 276006
🇩🇪Hamburg, Germany
Investigational Site Number 348004
🇭🇺Budapest, Hungary
Investigational Site Number 348005
🇭🇺Pécs, Hungary
Investigational Site Number 376003
🇮🇱Ashkelon, Israel
Investigational Site Number 376004
🇮🇱Haifa, Israel
Investigational Site Number 376002
🇮🇱Afula, Israel
Investigational Site Number 376001
🇮🇱Tel Aviv, Israel
Investigational Site Number 380004
🇮🇹Bari, Italy
Investigational Site Number 380001
🇮🇹Firenze, Italy
Investigational Site Number 380007
🇮🇹Roma, Italy
Investigational Site Number 380002
🇮🇹Como, Italy
Investigational Site Number 392001
🇯🇵Osaka Sayama-Shi, Japan
Investigational Site Number 392004
🇯🇵Meguro-Ku, Japan
Investigational Site Number 392006
🇯🇵Osaka-Shi, Japan
Investigational Site Number 392005
🇯🇵Niigata-Shi, Japan
Investigational Site Number 392002
🇯🇵Suita-Shi, Japan
Investigational Site Number 392003
🇯🇵Shinjuku-Ku, Japan
Investigational Site Number 484002
🇲🇽Mexico City, Mexico
Investigational Site Number 528005
🇳🇱Amsterdam, Netherlands
Investigational Site Number 528001
🇳🇱Alkmaar, Netherlands
Investigational Site Number 528002
🇳🇱Breda, Netherlands
Investigational Site Number 528007
🇳🇱Rotterdam, Netherlands
Investigational Site Number 528004
🇳🇱Zwolle, Netherlands
Investigational Site Number 528003
🇳🇱Maastricht, Netherlands
Investigational Site Number 620003
🇵🇹Lisboa, Portugal
Investigational Site Number 616007
🇵🇱Bydgoszcz, Poland
Investigational Site Number 616006
🇵🇱Lodz, Poland
Investigational Site Number 616011
🇵🇱Gdynia, Poland
Investigational Site Number 616003
🇵🇱Lodz, Poland
Investigational Site Number 578003
🇳🇴Drammen, Norway
Investigational Site Number 616008
🇵🇱Warszawa, Poland
Investigational Site Number 616001
🇵🇱Warszawa, Poland
Investigational Site Number 620004
🇵🇹Coimbra, Portugal
Investigational Site Number 643006
🇷🇺Ekaterinburg, Russian Federation
Investigational Site Number 643005
🇷🇺Moscow, Russian Federation
Investigational Site Number 643003
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 643007
🇷🇺Tyumen, Russian Federation
Investigational Site Number 643011
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 643004
🇷🇺Tomsk, Russian Federation
Investigational Site Number 703001
🇸🇰Bratislava, Slovakia
Investigational Site Number 710002
🇿🇦Pretoria, South Africa
Investigational Site Number 724001
🇪🇸Barcelona, Spain
Investigational Site Number 724002
🇪🇸Barcelona, Spain
Investigational Site Number 724004
🇪🇸Madrid, Spain
Investigational Site Number 724003
🇪🇸Madrid, Spain
Investigational Site Number 724006
🇪🇸Santiago De Compostela, Spain
Investigational Site Number 724009
🇪🇸Sevilla, Spain
Investigational Site Number 724007
🇪🇸Valencia, Spain
Investigational Site Number 752003
🇸🇪Umeå, Sweden
Investigational Site Number 752002
🇸🇪Stockholm, Sweden
Investigational Site Number 792001
🇹🇷Ankara, Turkey
Investigational Site Number 752001
🇸🇪Uppsala, Sweden
Investigational Site Number 792003
🇹🇷Istanbul, Turkey
Investigational Site Number 792002
🇹🇷Istanbul, Turkey
Investigational Site Number 036005
🇦🇺Herston, Australia
Investigational Site Number 840048
🇺🇸Rapid City, South Dakota, United States