Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death
NCT ID: NCT00993382
Last Updated: 2016-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
486 participants
INTERVENTIONAL
2009-09-30
2011-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Celivarone 50 mg
Celivarone, 50 mg once daily up to 10-15 days before the common study end date
Celivarone
Pharmaceutical form: capsule
Route of administration: oral
Matching placebo
Pharmaceutical form: capsule
Route of administration: oral
Matching placebo added to active drug if any for a total of 3 capsules per intake
Celivarone 100 mg
Celivarone, 100 mg once daily up to 10-15 days before the common study end date
Celivarone
Pharmaceutical form: capsule
Route of administration: oral
Matching placebo
Pharmaceutical form: capsule
Route of administration: oral
Matching placebo added to active drug if any for a total of 3 capsules per intake
Celivarone 300 mg
Celivarone, 300 mg once daily up to 10-15 days before the common study end date
Celivarone
Pharmaceutical form: capsule
Route of administration: oral
Matching placebo
Pharmaceutical form: capsule
Route of administration: oral
Matching placebo added to active drug if any for a total of 3 capsules per intake
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
Amiodarone
Pharmaceutical form: capsule
Route of administration: oral
Matching placebo
Pharmaceutical form: capsule
Route of administration: oral
Matching placebo added to active drug if any for a total of 3 capsules per intake
Placebo
Matching placebo once daily up to 10-15 days before the common study end date
Matching placebo
Pharmaceutical form: capsule
Route of administration: oral
Matching placebo added to active drug if any for a total of 3 capsules per intake
Interventions
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Celivarone
Pharmaceutical form: capsule
Route of administration: oral
Amiodarone
Pharmaceutical form: capsule
Route of administration: oral
Matching placebo
Pharmaceutical form: capsule
Route of administration: oral
Matching placebo added to active drug if any for a total of 3 capsules per intake
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* at least one ICD therapy for Ventricular Tachycardia (VT) OR
* Ventricular Fibrillation (VF) in the previous month OR
* ICD implantation in the previous month for documented VT/VF
Exclusion Criteria
* Women of childbearing potential without adequate birth control or pregnant or breastfeeding women
* Patients with known ICD lead problem (lead dislodgement)
* ICD without the following characteristics :
* data logging function with cumulative counting of device intervention (shocks and anti-tachycardia pacing \[ATP\])
* electrogram storage capabilities
* ventricular demand pacing.
* Recent unstable angina pectoris or myocardial infarction (\< 4 weeks),
* History of torsades de pointes,
* Genetic channelopathies including congenital long QT syndrome,
* Wolff-Parkinson-White syndrome,
* Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with intravenous pressor agents; patients on respirator; congestive heart failure of stage New York Heart Association (NYHA) IV within the last 4 weeks; uncorrected, hemodynamically significant primary obstructive valvular disease; hemodynamically significant obstructive cardiomyopathy; a cardiac operation or revascularization procedure within 4 weeks preceding randomization,
* Incessant sustained VT/VF (VT/VF that recurs promptly despite termination attempts) during the three days preceding randomization.
* Patients with inappropriate (not triggered by VT nor VF) shocks during the month preceding randomization.
* Clinically relevant haematologic, hepatobiliary (ALT, AST \> 3 times the upper limit of normal at randomization), gastro-intestinal, renal (serum creatinine \> 221 µmol/l (2.5 mg/dl) at randomization), pulmonary, endocrinologic or psychiatric disease.
* Patients treated with oral amiodarone (more than 20 tablets during the 2 months preceding randomization)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
21 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Peter KOWEY, Pr
Role: STUDY_CHAIR
Steering Committee Chair Person
Locations
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Investigational Site Number 840006
Huntsville, Alabama, United States
Investigational Site Number 840042
Mobile, Alabama, United States
Investigational Site Number 840014
Mesa, Arizona, United States
Investigational Site Number 840032
Phoenix, Arizona, United States
Investigational Site Number 840033
Tucson, Arizona, United States
Investigational Site Number 840054
Redondo Beach, California, United States
Investigational Site Number 840007
Redwood City, California, United States
Investigational Site Number 840039
Colorado Springs, Colorado, United States
Investigational Site Number 840002
Fort Myers, Florida, United States
Investigational Site Number 840010
Orlando, Florida, United States
Investigational Site Number 840005
Port Charlotte, Florida, United States
Investigational Site Number 840013
St. Petersburg, Florida, United States
Investigational Site Number 840043
St. Petersburg, Florida, United States
Investigational Site Number 840004
Augusta, Georgia, United States
Investigational Site Number 840045
Chicago, Illinois, United States
Investigational Site Number 840035
Lombard, Illinois, United States
Investigational Site Number 840017
Kansas City, Kansas, United States
Investigational Site Number 840022
Scarborough, Maine, United States
Investigational Site Number 840009
Ann Arbor, Michigan, 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 840031
New York, New York, United States
Investigational Site Number 840029
Tulsa, Oklahoma, United States
Investigational Site Number 840037
Portland, Oregon, United States
Investigational Site Number 840024
Camp Hill, Pennsylvania, United States
Investigational Site Number 840030
Doylestown, Pennsylvania, United States
Investigational Site Number 840034
Upland, Pennsylvania, United States
Investigational Site Number 840020
Charleston, South Carolina, United States
Investigational Site Number 840048
Rapid City, South Dakota, United States
Investigational Site Number 840011
Tullahoma, Tennessee, United States
Investigational Site Number 840025
Chesapeake, Virginia, United States
Investigational Site Number 840012
Norfolk, Virginia, United States
Investigational Site Number 840038
Richmond, Virginia, United States
Investigational Site Number 840016
Spokane, Washington, United States
Investigational Site Number 032002
Ciudad Autonoma de Bs.As, , Argentina
Investigational Site Number 032003
Corrientes, , Argentina
Investigational Site Number 032004
San Miguel de Tucumán, , Argentina
Investigational Site Number 036012
Adelaide, , Australia
Investigational Site Number 036006
Auchenflower, , Australia
Investigational Site Number 036004
Bedford Park, , Australia
Investigational Site Number 036014
Camperdown, , Australia
Investigational Site Number 036013
Garran, , Australia
Investigational Site Number 036010
Gosford, , Australia
Investigational Site Number 036005
Herston, , Australia
Investigational Site Number 036008
Nedlands, , Australia
Investigational Site Number 036009
New Lambton, , Australia
Investigational Site Number 036007
Perth, , Australia
Investigational Site Number 036003
Woolloongabba, , Australia
Investigational Site Number 056005
Aalst, , Belgium
Investigational Site Number 056007
Bruges, , Belgium
Investigational Site Number 056001
Brussels, , Belgium
Investigational Site Number 056002
Gilly, , 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 124007
Victoria, , Canada
Investigational Site Number 152001
Santiago, , Chile
Investigational Site Number 203004
Brno, , Czechia
Investigational Site Number 203002
České Budějovice, , Czechia
Investigational Site Number 203005
Hradec Králové, , Czechia
Investigational Site Number 203001
Liberec, , Czechia
Investigational Site Number 203003
Olomouc, , Czechia
Investigational Site Number 203006
Prague, , Czechia
Investigational Site Number 208002
Aarhus, , Denmark
Investigational Site Number 208004
Hellerup, , Denmark
Investigational Site Number 208005
København Ø, , Denmark
Investigational Site Number 208001
Odense C, , Denmark
Investigational Site Number 246001
Helsinki, , Finland
Investigational Site Number 246004
Tampere, , Finland
Investigational Site Number 250004
Brest, , France
Investigational Site Number 250006
Grenoble, , France
Investigational Site Number 250005
Lille, , France
Investigational Site Number 250002
Montpellier, , France
Investigational Site Number 250001
Paris, , France
Investigational Site Number 250007
Rennes, , France
Investigational Site Number 250003
Vandœuvre-lès-Nancy, , France
Investigational Site Number 276005
Bad Neustadt an der Saale, , Germany
Investigational Site Number 276002
Bernau, , Germany
Investigational Site Number 276003
Dresden, , Germany
Investigational Site Number 276001
Frankfurt am Main, , Germany
Investigational Site Number 276006
Hamburg, , Germany
Investigational Site Number 348001
Balatonfüred, , Hungary
Investigational Site Number 348004
Budapest, , Hungary
Investigational Site Number 348005
Pécs, , Hungary
Investigational Site Number 348003
Zalaegerszeg, , Hungary
Investigational Site Number 376002
Afula, , Israel
Investigational Site Number 376003
Ashkelon, , Israel
Investigational Site Number 376004
Haifa, , Israel
Investigational Site Number 376001
Tel Aviv, , Israel
Investigational Site Number 380004
Bari, , Italy
Investigational Site Number 380008
Bergamo, , Italy
Investigational Site Number 380002
Como, , Italy
Investigational Site Number 380001
Florence, , Italy
Investigational Site Number 380007
Roma, , Italy
Investigational Site Number 392004
Meguro-Ku, , Japan
Investigational Site Number 392005
Niigata, , Japan
Investigational Site Number 392006
Osaka, , Japan
Investigational Site Number 392001
Osaka Sayama-Shi, , Japan
Investigational Site Number 392003
Shinjuku-Ku, , Japan
Investigational Site Number 392002
Suita-Shi, , Japan
Investigational Site Number 484002
Mexico City, , Mexico
Investigational Site Number 528001
Alkmaar, , Netherlands
Investigational Site Number 528005
Amsterdam, , Netherlands
Investigational Site Number 528002
Breda, , Netherlands
Investigational Site Number 528003
Maastricht, , Netherlands
Investigational Site Number 528007
Rotterdam, , Netherlands
Investigational Site Number 528004
Zwolle, , Netherlands
Investigational Site Number 578003
Drammen, , Norway
Investigational Site Number 616007
Bydgoszcz, , Poland
Investigational Site Number 616011
Gdynia, , Poland
Investigational Site Number 616006
Lodz, , Poland
Investigational Site Number 616003
Lodz, , Poland
Investigational Site Number 616002
Szczecin, , Poland
Investigational Site Number 616008
Warsaw, , Poland
Investigational Site Number 616001
Warsaw, , Poland
Investigational Site Number 620004
Coimbra, , Portugal
Investigational Site Number 620003
Lisbon, , Portugal
Investigational Site Number 620005
Vila Nova de Gaia, , Portugal
Investigational Site Number 643005
Moscow, , Russia
Investigational Site Number 643003
Saint Petersburg, , Russia
Investigational Site Number 643011
Saint Petersburg, , Russia
Investigational Site Number 643008
Samara, , Russia
Investigational Site Number 643004
Tomsk, , Russia
Investigational Site Number 643007
Tyumen, , Russia
Investigational Site Number 643006
Yekaterinburg, , Russia
Investigational Site Number 703001
Bratislava, , Slovakia
Investigational Site Number 703002
Košice, , 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
Seville, , Spain
Investigational Site Number 724007
Valencia, , Spain
Investigational Site Number 752002
Stockholm, , Sweden
Investigational Site Number 752003
Umeå, , Sweden
Investigational Site Number 752001
Uppsala, , Sweden
Investigational Site Number 792001
Ankara, , Turkey (Türkiye)
Investigational Site Number 792003
Istanbul, , Turkey (Türkiye)
Investigational Site Number 792002
Istanbul, , Turkey (Türkiye)
Countries
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References
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Kowey PR, Crijns HJ, Aliot EM, Capucci A, Kulakowski P, Radzik D, Roy D, Connolly SJ, Hohnloser SH; ALPHEE Study Investigators. Efficacy and safety of celivarone, with amiodarone as calibrator, in patients with an implantable cardioverter-defibrillator for prevention of implantable cardioverter-defibrillator interventions or death: the ALPHEE study. Circulation. 2011 Dec 13;124(24):2649-60. doi: 10.1161/CIRCULATIONAHA.111.072561. Epub 2011 Nov 14.
Other Identifiers
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2008-008412-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DRI10936
Identifier Type: -
Identifier Source: org_study_id
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