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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00993382




Registration number
NCT00993382
Ethics application status
Date submitted
9/10/2009
Date registered
12/10/2009
Date last updated
30/05/2016

Titles & IDs
Public title
Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death
Scientific 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
Secondary ID [1] 0 0
2008-008412-47
Secondary ID [2] 0 0
DRI10936
Universal Trial Number (UTN)
Trial acronym
ALPHEE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arrhythmia Prophylaxis 0 0
Ventricular Arrhythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Celivarone
Treatment: Drugs - Amiodarone
Treatment: Drugs - Matching placebo

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

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

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

Active comparator: 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

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


Treatment: Drugs: Celivarone
Pharmaceutical form: capsule

Route of administration: oral

Treatment: Drugs: Amiodarone
Pharmaceutical form: capsule

Route of administration: oral

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Ventricular Tachycardia or Ventricular Fibrillation (VT/VF) triggered ICD interventions or sudden death
Timepoint [1] 0 0
up to 20 months (median follow-up of 12 months)
Secondary outcome [1] 0 0
Time to ICD shocks (appropriate or inappropriate) or death from any cause
Timepoint [1] 0 0
up to 20 months (median follow-up of 12 months)
Secondary outcome [2] 0 0
Time to Cardiovascular hospitalization or death
Timepoint [2] 0 0
up to 20 months (median follow-up of 12 months)

Eligibility
Key inclusion 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
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
486
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036012 - Adelaide
Recruitment hospital [2] 0 0
Investigational Site Number 036006 - Auchenflower
Recruitment hospital [3] 0 0
Investigational Site Number 036004 - Bedford Park
Recruitment hospital [4] 0 0
Investigational Site Number 036014 - Camperdown
Recruitment hospital [5] 0 0
Investigational Site Number 036013 - Garran
Recruitment hospital [6] 0 0
Investigational Site Number 036010 - Gosford
Recruitment hospital [7] 0 0
Investigational Site Number 036005 - Herston
Recruitment hospital [8] 0 0
Investigational Site Number 036008 - Nedlands
Recruitment hospital [9] 0 0
Investigational Site Number 036009 - New Lambton
Recruitment hospital [10] 0 0
Investigational Site Number 036007 - Perth
Recruitment hospital [11] 0 0
Investigational Site Number 036003 - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
2050 - Camperdown
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2605 - Garran
Recruitment postcode(s) [6] 0 0
2250 - Gosford
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment postcode(s) [9] 0 0
2305 - New Lambton
Recruitment postcode(s) [10] 0 0
6000 - Perth
Recruitment postcode(s) [11] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00993382
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Peter KOWEY, Pr
Address 0 0
Steering Committee Chair Person
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00993382