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Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death (ALPHEE)

Primary Purpose

Arrhythmia Prophylaxis, Ventricular Arrhythmia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Celivarone
Amiodarone
Matching placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arrhythmia Prophylaxis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria :

  • Implantable Cardioverter Defibrillator (ICD) patients with a Left Ventricular Ejection Fraction (LVEF) of 40% or less AND one of the following 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 :

  • Patients of either sex aged below 21 years (or the age of legal consent of the country),
  • 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.

Sites / Locations

  • Investigational Site Number 840006
  • Investigational Site Number 840042
  • Investigational Site Number 840014
  • Investigational Site Number 840032
  • Investigational Site Number 840033
  • Investigational Site Number 840054
  • Investigational Site Number 840007
  • Investigational Site Number 840039
  • Investigational Site Number 840002
  • Investigational Site Number 840010
  • Investigational Site Number 840005
  • Investigational Site Number 840013
  • Investigational Site Number 840043
  • Investigational Site Number 840004
  • Investigational Site Number 840045
  • Investigational Site Number 840035
  • Investigational Site Number 840017
  • Investigational Site Number 840022
  • Investigational Site Number 840009
  • Investigational Site Number 840026
  • Investigational Site Number 840003
  • Investigational Site Number 840015
  • Investigational Site Number 840049
  • Investigational Site Number 840019
  • Investigational Site Number 840031
  • Investigational Site Number 840029
  • Investigational Site Number 840037
  • Investigational Site Number 840024
  • Investigational Site Number 840030
  • Investigational Site Number 840034
  • Investigational Site Number 840020
  • Investigational Site Number 840048
  • Investigational Site Number 840011
  • Investigational Site Number 840025
  • Investigational Site Number 840012
  • Investigational Site Number 840038
  • Investigational Site Number 840016
  • Investigational Site Number 032002
  • Investigational Site Number 032003
  • Investigational Site Number 032004
  • Investigational Site Number 036012
  • Investigational Site Number 036006
  • Investigational Site Number 036004
  • Investigational Site Number 036014
  • Investigational Site Number 036013
  • Investigational Site Number 036010
  • Investigational Site Number 036005
  • Investigational Site Number 036008
  • Investigational Site Number 036009
  • Investigational Site Number 036007
  • Investigational Site Number 036003
  • Investigational Site Number 056005
  • Investigational Site Number 056007
  • Investigational Site Number 056001
  • Investigational Site Number 056002
  • Investigational Site Number 056004
  • Investigational Site Number 056003
  • Investigational Site Number 124009
  • Investigational Site Number 124010
  • Investigational Site Number 124004
  • Investigational Site Number 124008
  • Investigational Site Number 124001
  • Investigational Site Number 124005
  • Investigational Site Number 124002
  • Investigational Site Number 124006
  • Investigational Site Number 124007
  • Investigational Site Number 152001
  • Investigational Site Number 203004
  • Investigational Site Number 203002
  • Investigational Site Number 203005
  • Investigational Site Number 203001
  • Investigational Site Number 203003
  • Investigational Site Number 203006
  • Investigational Site Number 208002
  • Investigational Site Number 208004
  • Investigational Site Number 208005
  • Investigational Site Number 208001
  • Investigational Site Number 246001
  • Investigational Site Number 246004
  • Investigational Site Number 250004
  • Investigational Site Number 250006
  • Investigational Site Number 250005
  • Investigational Site Number 250002
  • Investigational Site Number 250001
  • Investigational Site Number 250007
  • Investigational Site Number 250003
  • Investigational Site Number 276005
  • Investigational Site Number 276002
  • Investigational Site Number 276003
  • Investigational Site Number 276001
  • Investigational Site Number 276006
  • Investigational Site Number 348001
  • Investigational Site Number 348004
  • Investigational Site Number 348005
  • Investigational Site Number 348003
  • Investigational Site Number 376002
  • Investigational Site Number 376003
  • Investigational Site Number 376004
  • Investigational Site Number 376001
  • Investigational Site Number 380004
  • Investigational Site Number 380008
  • Investigational Site Number 380002
  • Investigational Site Number 380001
  • Investigational Site Number 380007
  • Investigational Site Number 392004
  • Investigational Site Number 392005
  • Investigational Site Number 392001
  • Investigational Site Number 392006
  • Investigational Site Number 392003
  • Investigational Site Number 392002
  • Investigational Site Number 484002
  • Investigational Site Number 528001
  • Investigational Site Number 528005
  • Investigational Site Number 528002
  • Investigational Site Number 528003
  • Investigational Site Number 528007
  • Investigational Site Number 528004
  • Investigational Site Number 578003
  • Investigational Site Number 616007
  • Investigational Site Number 616011
  • Investigational Site Number 616006
  • Investigational Site Number 616003
  • Investigational Site Number 616002
  • Investigational Site Number 616008
  • Investigational Site Number 616001
  • Investigational Site Number 620004
  • Investigational Site Number 620003
  • Investigational Site Number 620005
  • Investigational Site Number 643006
  • Investigational Site Number 643005
  • Investigational Site Number 643008
  • Investigational Site Number 643003
  • Investigational Site Number 643011
  • Investigational Site Number 643004
  • Investigational Site Number 643007
  • Investigational Site Number 703001
  • Investigational Site Number 703002
  • Investigational Site Number 710002
  • Investigational Site Number 724001
  • Investigational Site Number 724002
  • Investigational Site Number 724004
  • Investigational Site Number 724003
  • Investigational Site Number 724006
  • Investigational Site Number 724009
  • Investigational Site Number 724007
  • Investigational Site Number 752002
  • Investigational Site Number 752003
  • Investigational Site Number 752001
  • Investigational Site Number 792001
  • Investigational Site Number 792003
  • Investigational Site Number 792002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Celivarone 50 mg

Celivarone 100 mg

Celivarone 300 mg

Amiodarone

Placebo

Arm Description

Celivarone, 50 mg once daily up to 10-15 days before the common study end date

Celivarone, 100 mg once daily up to 10-15 days before the common study end date

Celivarone, 300 mg once daily up to 10-15 days before the common study end date

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

Matching placebo once daily up to 10-15 days before the common study end date

Outcomes

Primary Outcome Measures

Time to Ventricular Tachycardia or Ventricular Fibrillation (VT/VF) triggered ICD interventions or sudden death
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

Time to ICD shocks (appropriate or inappropriate) or death from any cause
Time to Cardiovascular hospitalization or death

Full Information

First Posted
October 9, 2009
Last Updated
May 2, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00993382
Brief Title
Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death
Acronym
ALPHEE
Official Title
Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Celivarone at 50, 100 or 300 mg OD With Amiodarone as Calibrator for the Prevention of ICD Interventions or Death
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia Prophylaxis, Ventricular Arrhythmia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
486 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celivarone 50 mg
Arm Type
Experimental
Arm Description
Celivarone, 50 mg once daily up to 10-15 days before the common study end date
Arm Title
Celivarone 100 mg
Arm Type
Experimental
Arm Description
Celivarone, 100 mg once daily up to 10-15 days before the common study end date
Arm Title
Celivarone 300 mg
Arm Type
Experimental
Arm Description
Celivarone, 300 mg once daily up to 10-15 days before the common study end date
Arm Title
Amiodarone
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo once daily up to 10-15 days before the common study end date
Intervention Type
Drug
Intervention Name(s)
Celivarone
Other Intervention Name(s)
SSR149744
Intervention Description
Pharmaceutical form: capsule Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Other Intervention Name(s)
Cordarone
Intervention Description
Pharmaceutical form: capsule Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Intervention Description
Pharmaceutical form: capsule Route of administration: oral Matching placebo added to active drug if any for a total of 3 capsules per intake
Primary Outcome Measure Information:
Title
Time to Ventricular Tachycardia or Ventricular Fibrillation (VT/VF) triggered ICD interventions or sudden death
Description
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.
Time Frame
up to 20 months (median follow-up of 12 months)
Secondary Outcome Measure Information:
Title
Time to ICD shocks (appropriate or inappropriate) or death from any cause
Time Frame
up to 20 months (median follow-up of 12 months)
Title
Time to Cardiovascular hospitalization or death
Time Frame
up to 20 months (median follow-up of 12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : Implantable Cardioverter Defibrillator (ICD) patients with a Left Ventricular Ejection Fraction (LVEF) of 40% or less AND one of the following 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 : Patients of either sex aged below 21 years (or the age of legal consent of the country), 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter KOWEY, Pr
Organizational Affiliation
Steering Committee Chair Person
Official's Role
Study Chair
Facility Information:
Facility Name
Investigational Site Number 840006
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Investigational Site Number 840042
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Investigational Site Number 840014
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Investigational Site Number 840032
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Investigational Site Number 840033
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Investigational Site Number 840054
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Investigational Site Number 840007
City
Redwood City
State/Province
California
ZIP/Postal Code
94062
Country
United States
Facility Name
Investigational Site Number 840039
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Investigational Site Number 840002
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Investigational Site Number 840010
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigational Site Number 840005
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952-8008
Country
United States
Facility Name
Investigational Site Number 840013
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Investigational Site Number 840043
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Investigational Site Number 840004
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Investigational Site Number 840045
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Investigational Site Number 840035
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Investigational Site Number 840017
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Investigational Site Number 840022
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Investigational Site Number 840009
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0759
Country
United States
Facility Name
Investigational Site Number 840026
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Investigational Site Number 840003
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Investigational Site Number 840015
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Investigational Site Number 840049
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Investigational Site Number 840019
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Investigational Site Number 840031
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Investigational Site Number 840029
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Investigational Site Number 840037
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Investigational Site Number 840024
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Investigational Site Number 840030
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Investigational Site Number 840034
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Investigational Site Number 840020
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Investigational Site Number 840048
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Investigational Site Number 840011
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
Investigational Site Number 840025
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Investigational Site Number 840012
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Investigational Site Number 840038
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Investigational Site Number 840016
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Investigational Site Number 032002
City
Ciudad Autonoma De Bs.As
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Investigational Site Number 032003
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
Facility Name
Investigational Site Number 032004
City
San Miguel De Tucuman
ZIP/Postal Code
T4000NIL
Country
Argentina
Facility Name
Investigational Site Number 036012
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Investigational Site Number 036006
City
Auchenflower
ZIP/Postal Code
4066
Country
Australia
Facility Name
Investigational Site Number 036004
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
Investigational Site Number 036014
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Investigational Site Number 036013
City
Garran
ZIP/Postal Code
2605
Country
Australia
Facility Name
Investigational Site Number 036010
City
Gosford
ZIP/Postal Code
2250
Country
Australia
Facility Name
Investigational Site Number 036005
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
Investigational Site Number 036008
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Investigational Site Number 036009
City
New Lambton
ZIP/Postal Code
2305
Country
Australia
Facility Name
Investigational Site Number 036007
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Investigational Site Number 036003
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Investigational Site Number 056005
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Investigational Site Number 056007
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Investigational Site Number 056001
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Investigational Site Number 056002
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Investigational Site Number 056004
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Investigational Site Number 056003
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Investigational Site Number 124009
City
Calgary
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Investigational Site Number 124010
City
Hamilton
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Investigational Site Number 124004
City
London
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Investigational Site Number 124008
City
Montreal
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Investigational Site Number 124001
City
Montreal
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Investigational Site Number 124005
City
Ste-Foy
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Investigational Site Number 124002
City
Toronto
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Investigational Site Number 124006
City
Vancouver
ZIP/Postal Code
V6E 1M9
Country
Canada
Facility Name
Investigational Site Number 124007
City
Victoria
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Investigational Site Number 152001
City
Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Investigational Site Number 203004
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
Facility Name
Investigational Site Number 203002
City
Ceske Budejovice
ZIP/Postal Code
37087
Country
Czech Republic
Facility Name
Investigational Site Number 203005
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic
Facility Name
Investigational Site Number 203001
City
Liberec
ZIP/Postal Code
46063
Country
Czech Republic
Facility Name
Investigational Site Number 203003
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Investigational Site Number 203006
City
Praha 5
ZIP/Postal Code
15030
Country
Czech Republic
Facility Name
Investigational Site Number 208002
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Investigational Site Number 208004
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Investigational Site Number 208005
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Investigational Site Number 208001
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Investigational Site Number 246001
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Investigational Site Number 246004
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Investigational Site Number 250004
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Investigational Site Number 250006
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Investigational Site Number 250005
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number 250002
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number 250001
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
Investigational Site Number 250007
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Investigational Site Number 250003
City
Vandoeuvre Les Nancy Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Investigational Site Number 276005
City
Bad Neustadt
ZIP/Postal Code
97616
Country
Germany
Facility Name
Investigational Site Number 276002
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
Investigational Site Number 276003
City
Dresden
ZIP/Postal Code
01099
Country
Germany
Facility Name
Investigational Site Number 276001
City
Frankfurt Am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Investigational Site Number 276006
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Investigational Site Number 348001
City
Balatonfüred
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Investigational Site Number 348004
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Investigational Site Number 348005
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Investigational Site Number 348003
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Investigational Site Number 376002
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Investigational Site Number 376003
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Investigational Site Number 376004
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Investigational Site Number 376001
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Investigational Site Number 380004
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Investigational Site Number 380008
City
Bergamo
ZIP/Postal Code
24125
Country
Italy
Facility Name
Investigational Site Number 380002
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
Investigational Site Number 380001
City
Firenze
ZIP/Postal Code
50141
Country
Italy
Facility Name
Investigational Site Number 380007
City
Roma
ZIP/Postal Code
00169
Country
Italy
Facility Name
Investigational Site Number 392004
City
Meguro-Ku
Country
Japan
Facility Name
Investigational Site Number 392005
City
Niigata-Shi
Country
Japan
Facility Name
Investigational Site Number 392001
City
Osaka Sayama-Shi
Country
Japan
Facility Name
Investigational Site Number 392006
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392003
City
Shinjuku-Ku
Country
Japan
Facility Name
Investigational Site Number 392002
City
Suita-Shi
Country
Japan
Facility Name
Investigational Site Number 484002
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Investigational Site Number 528001
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Investigational Site Number 528005
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Investigational Site Number 528002
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Investigational Site Number 528003
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Investigational Site Number 528007
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Investigational Site Number 528004
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
Facility Name
Investigational Site Number 578003
City
Drammen
ZIP/Postal Code
3004
Country
Norway
Facility Name
Investigational Site Number 616007
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Investigational Site Number 616011
City
Gdynia
ZIP/Postal Code
81-348
Country
Poland
Facility Name
Investigational Site Number 616006
City
Lodz
ZIP/Postal Code
90-548
Country
Poland
Facility Name
Investigational Site Number 616003
City
Lodz
ZIP/Postal Code
91-425
Country
Poland
Facility Name
Investigational Site Number 616002
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Investigational Site Number 616008
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Investigational Site Number 616001
City
Warszawa
ZIP/Postal Code
04-073
Country
Poland
Facility Name
Investigational Site Number 620004
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Investigational Site Number 620003
City
Lisboa
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
Investigational Site Number 620005
City
Vila Nova De Gaia
ZIP/Postal Code
4430-502
Country
Portugal
Facility Name
Investigational Site Number 643006
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Investigational Site Number 643005
City
Moscow
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Investigational Site Number 643008
City
Samara
ZIP/Postal Code
443070
Country
Russian Federation
Facility Name
Investigational Site Number 643003
City
St-Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Investigational Site Number 643011
City
St-Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Investigational Site Number 643004
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Facility Name
Investigational Site Number 643007
City
Tyumen
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Investigational Site Number 703001
City
Bratislava
ZIP/Postal Code
81104
Country
Slovakia
Facility Name
Investigational Site Number 703002
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
Investigational Site Number 710002
City
Pretoria
ZIP/Postal Code
181
Country
South Africa
Facility Name
Investigational Site Number 724001
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number 724002
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Investigational Site Number 724004
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Investigational Site Number 724003
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Investigational Site Number 724006
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Investigational Site Number 724009
City
Sevilla
ZIP/Postal Code
41008
Country
Spain
Facility Name
Investigational Site Number 724007
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Investigational Site Number 752002
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Investigational Site Number 752003
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Investigational Site Number 752001
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Investigational Site Number 792001
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Investigational Site Number 792003
City
Istanbul
ZIP/Postal Code
34304
Country
Turkey
Facility Name
Investigational Site Number 792002
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
22082672
Citation
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.
Results Reference
result

Learn more about this trial

Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death

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