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Arrhythmia ProphylaxisPhase 2ALPHEENCT00993382

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

A Phase 2 study testing Celivarone and Amiodarone in people with Arrhythmia Prophylaxis and Ventricular Arrhythmia, run by Sanofi at 151 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Celivarone and Amiodarone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
486 participants
Where
151 sitesin 26 countries
Study dates
Sep 2009to May 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

151 sites in 26 countries.

151 sites in 26 countries

United States37 sites

  • Investigational Site Number 840009

    Ann Arbor, Michigan, 48109-0759

  • Investigational Site Number 840004

    Augusta, Georgia, 30901

  • Investigational Site Number 840024

    Camp Hill, Pennsylvania, 17011

  • Investigational Site Number 840020

    Charleston, South Carolina, 29406

  • Investigational Site Number 840025

    Chesapeake, Virginia, 23320

  • Investigational Site Number 840045

    Chicago, Illinois, 60637

  • Investigational Site Number 840039

    Colorado Springs, Colorado, 80909

  • Investigational Site Number 840049

    Columbia, Missouri, 65201

  • Investigational Site Number 840026

    Detroit, Michigan, 48236

  • Investigational Site Number 840030

    Doylestown, Pennsylvania, 18901

  • Investigational Site Number 840002

    Fort Myers, Florida, 33908

  • Investigational Site Number 840006

    Huntsville, Alabama, 35801

  • Investigational Site Number 840017

    Kansas City, Kansas, 66160

  • Investigational Site Number 840019

    Kansas City, Missouri, 64114

  • Investigational Site Number 840035

    Lombard, Illinois, 60148

  • Investigational Site Number 840014

    Mesa, Arizona, 85206

  • Investigational Site Number 840042

    Mobile, Alabama, 36608

  • Investigational Site Number 840031

    New York, New York, 10001

  • Investigational Site Number 840012

    Norfolk, Virginia, 23507

  • Investigational Site Number 840010

    Orlando, Florida, 32806

  • Investigational Site Number 840003

    Petoskey, Michigan, 49770

  • Investigational Site Number 840032

    Phoenix, Arizona, 85006

  • Investigational Site Number 840005

    Port Charlotte, Florida, 33952-8008

  • Investigational Site Number 840037

    Portland, Oregon, 97201-3098

  • Investigational Site Number 840048

    Rapid City, South Dakota, 57701

  • Investigational Site Number 840054

    Redondo Beach, California, 90277

  • Investigational Site Number 840007

    Redwood City, California, 94062

  • Investigational Site Number 840038

    Richmond, Virginia, 23225

  • Investigational Site Number 840022

    Scarborough, Maine, 04074

  • Investigational Site Number 840016

    Spokane, Washington, 99204

  • Investigational Site Number 840013

    St. Petersburg, Florida, 33707

  • Investigational Site Number 840043

    St. Petersburg, Florida, 33707

  • Investigational Site Number 840033

    Tucson, Arizona, 85723

  • Investigational Site Number 840011

    Tullahoma, Tennessee, 37388

  • Investigational Site Number 840029

    Tulsa, Oklahoma, 74104

  • Investigational Site Number 840034

    Upland, Pennsylvania, 19013

  • Investigational Site Number 840015

    Ypsilanti, Michigan, 48197

Other trials in United States

Australia11 sites

  • Investigational Site Number 036012

    Adelaide, 5000

  • Investigational Site Number 036006

    Auchenflower, 4066

  • Investigational Site Number 036004

    Bedford Park, 5042

  • Investigational Site Number 036014

    Camperdown, 2050

  • Investigational Site Number 036013

    Garran, 2605

  • Investigational Site Number 036010

    Gosford, 2250

  • Investigational Site Number 036005

    Herston, 4029

  • Investigational Site Number 036008

    Nedlands, 6009

  • Investigational Site Number 036009

    New Lambton, 2305

  • Investigational Site Number 036007

    Perth, 6000

  • Investigational Site Number 036003

    Woolloongabba, 4102

Other trials in Australia

Canada9 sites

  • Investigational Site Number 124009

    Calgary, T2N 2T9

  • Investigational Site Number 124010

    Hamilton, L8L 2X2

  • Investigational Site Number 124004

    London, N6A 5A5

  • Investigational Site Number 124008

    Montreal, H1T 1C8

  • Investigational Site Number 124001

    Montreal, H2W 1T8

  • Investigational Site Number 124005

    Ste-Foy, G1V 4G5

  • Investigational Site Number 124002

    Toronto, M5B 1W8

  • Investigational Site Number 124006

    Vancouver, V6E 1M9

  • Investigational Site Number 124007

    Victoria, V8R 4R2

Other trials in Canada

France7 sites

  • Investigational Site Number 250004

    Brest, 29609

  • Investigational Site Number 250006

    Grenoble, 38043

  • Investigational Site Number 250005

    Lille, 59037

  • Investigational Site Number 250002

    Montpellier, 34295

  • Investigational Site Number 250001

    Paris, 75908

  • Investigational Site Number 250007

    Rennes, 35033

  • Investigational Site Number 250003

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Poland7 sites

  • Investigational Site Number 616007

    Bydgoszcz, 85-094

  • Investigational Site Number 616011

    Gdynia, 81-348

  • Investigational Site Number 616006

    Lodz, 90-548

  • Investigational Site Number 616003

    Lodz, 91-425

  • Investigational Site Number 616002

    Szczecin, 70-111

  • Investigational Site Number 616008

    Warsaw, 02-097

  • Investigational Site Number 616001

    Warsaw, 04-073

Other trials in Poland

Russia7 sites

  • Investigational Site Number 643005

    Moscow, 650002

  • Investigational Site Number 643003

    Saint Petersburg, 197110

  • Investigational Site Number 643011

    Saint Petersburg, 199106

  • Investigational Site Number 643008

    Samara, 443070

  • Investigational Site Number 643004

    Tomsk, 634012

  • Investigational Site Number 643007

    Tyumen, 625023

  • Investigational Site Number 643006

    Yekaterinburg, 620102

Other trials in Russia

Spain7 sites

  • Investigational Site Number 724001

    Barcelona, 08036

  • Investigational Site Number 724002

    Barcelona, 08907

  • Investigational Site Number 724004

    Madrid, 28035

  • Investigational Site Number 724003

    Madrid, 28046

  • Investigational Site Number 724006

    Santiago de Compostela, 15706

  • Investigational Site Number 724009

    Seville, 41008

  • Investigational Site Number 724007

    Valencia, 46026

Other trials in Spain

Belgium6 sites

  • Investigational Site Number 056005

    Aalst, 9300

  • Investigational Site Number 056007

    Bruges, 8000

  • Investigational Site Number 056001

    Brussels, 1090

  • Investigational Site Number 056002

    Gilly, 6060

  • Investigational Site Number 056004

    Hasselt, 3500

  • Investigational Site Number 056003

    Roeselare, 8800

Other trials in Belgium

Czechia6 sites

  • Investigational Site Number 203004

    Brno, 65691

  • Investigational Site Number 203002

    České Budějovice, 37087

  • Investigational Site Number 203005

    Hradec Králové, 50005

  • Investigational Site Number 203001

    Liberec, 46063

  • Investigational Site Number 203003

    Olomouc, 77520

  • Investigational Site Number 203006

    Prague, 15030

Other trials in Czechia

Japan6 sites

  • Investigational Site Number 392004

    Meguro-Ku

  • Investigational Site Number 392005

    Niigata

  • Investigational Site Number 392006

    Osaka

  • Investigational Site Number 392001

    Osaka Sayama-Shi

  • Investigational Site Number 392003

    Shinjuku-Ku

  • Investigational Site Number 392002

    Suita-Shi

Other trials in Japan

Netherlands6 sites

  • Investigational Site Number 528001

    Alkmaar, 1815 JD

  • Investigational Site Number 528005

    Amsterdam, 1091 AC

  • Investigational Site Number 528002

    Breda, 4818 CK

  • Investigational Site Number 528003

    Maastricht, 6229 HX

  • Investigational Site Number 528007

    Rotterdam, 3015 CE

  • Investigational Site Number 528004

    Zwolle, 8011 JW

Other trials in Netherlands

Germany5 sites

  • Investigational Site Number 276005

    Bad Neustadt an der Saale, 97616

  • Investigational Site Number 276002

    Bernau, 16321

  • Investigational Site Number 276003

    Dresden, 01099

  • Investigational Site Number 276001

    Frankfurt am Main, 60590

  • Investigational Site Number 276006

    Hamburg, 20246

Other trials in Germany

Italy5 sites

  • Investigational Site Number 380004

    Bari, 70124

  • Investigational Site Number 380008

    Bergamo, 24125

  • Investigational Site Number 380002

    Como, 22100

  • Investigational Site Number 380001

    Florence, 50141

  • Investigational Site Number 380007

    Roma, 00169

Other trials in Italy

Denmark4 sites

  • Investigational Site Number 208002

    Aarhus, 8200

  • Investigational Site Number 208004

    Hellerup, 2900

  • Investigational Site Number 208005

    København Ø, 2100

  • Investigational Site Number 208001

    Odense C, 5000

Other trials in Denmark

Hungary4 sites

  • Investigational Site Number 348001

    Balatonfüred, 8230

  • Investigational Site Number 348004

    Budapest, 1027

  • Investigational Site Number 348005

    Pécs, 7624

  • Investigational Site Number 348003

    Zalaegerszeg, 8900

Other trials in Hungary

Israel4 sites

  • Investigational Site Number 376002

    Afula, 18101

  • Investigational Site Number 376003

    Ashkelon, 78278

  • Investigational Site Number 376004

    Haifa, 31048

  • Investigational Site Number 376001

    Tel Aviv, 64239

Other trials in Israel

Argentina3 sites

  • Investigational Site Number 032002

    Ciudad Autonoma de Bs.As, 1428

  • Investigational Site Number 032003

    Corrientes, 3400

  • Investigational Site Number 032004

    San Miguel de Tucumán, T4000NIL

Other trials in Argentina

Portugal3 sites

  • Investigational Site Number 620004

    Coimbra, 3000-075

  • Investigational Site Number 620003

    Lisbon, 1169-024

  • Investigational Site Number 620005

    Vila Nova de Gaia, 4430-502

Other trials in Portugal

Sweden3 sites

  • Investigational Site Number 752002

    Stockholm, 118 83

  • Investigational Site Number 752003

    Umeå, 901 85

  • Investigational Site Number 752001

    Uppsala, 751 85

Other trials in Sweden

Turkey (Türkiye)3 sites

  • Investigational Site Number 792001

    Ankara, 06490

  • Investigational Site Number 792003

    Istanbul, 34304

  • Investigational Site Number 792002

    Istanbul, 34390

Other trials in Turkey (Türkiye)

Finland2 sites

  • Investigational Site Number 246001

    Helsinki, 00290

  • Investigational Site Number 246004

    Tampere, 33520

Other trials in Finland

Slovakia2 sites

  • Investigational Site Number 703001

    Bratislava, 81104

  • Investigational Site Number 703002

    Košice, 04011

Other trials in Slovakia

Chile1 site

  • Investigational Site Number 152001

    Santiago, 8380456

Other trials in Chile

Mexico1 site

  • Investigational Site Number 484002

    Mexico City, 14080

Other trials in Mexico

Norway1 site

  • Investigational Site Number 578003

    Drammen, 3004

Other trials in Norway

South Africa1 site

  • Investigational Site Number 710002

    Pretoria, 181

Other trials in South Africa

About this study

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

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.
Read the 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.

Being tested
Celivarone, Amiodarone, Matching placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CelivaroneDrug

    Also called SSR149744

    Pharmaceutical form: capsule

    Route of administration: oral

  • AmiodaroneDrug

    Also called Cordarone

    Pharmaceutical form: capsule

    Route of administration: oral

  • Matching placeboDrug

    Pharmaceutical form: capsule

    Route of administration: oral

    Matching placebo added to active drug if any for a total of 3 capsules per intake

Study groups in NCT00993382
Study groupRoleWhat they receive
Celivarone 50 mgExperimentalCelivarone, 50 mg once daily up to 10-15 days before the common study end date
Receives: Drug: Celivarone; Drug: Matching placebo
Celivarone 100 mgExperimentalCelivarone, 100 mg once daily up to 10-15 days before the common study end date
Receives: Drug: Celivarone; Drug: Matching placebo
Celivarone 300 mgExperimentalCelivarone, 300 mg once daily up to 10-15 days before the common study end date
Receives: Drug: Celivarone; Drug: Matching placebo
AmiodaroneActive comparatorAmiodarone, 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
Receives: Drug: Amiodarone; Drug: Matching placebo
PlaceboPlacebo comparatorMatching placebo once daily up to 10-15 days before the common study end date
Receives: Drug: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 20 months (median follow-up of 12 months)

Secondary outcomes (2)

  1. Time to ICD shocks (appropriate or inappropriate) or death from any cause

    Measured: up to 20 months (median follow-up of 12 months)

  2. Time to Cardiovascular hospitalization or death

    Measured: up to 20 months (median follow-up of 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
486 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00993382
Sponsor's protocol ID
DRI10936
Other IDs
2008-008412-47, 2008
Acronym
ALPHEE
Status last verified
May 2016
First submitted
9 Oct 2009
Last updated
30 May 2016
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 22082672

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Celivarone and Amiodarone in people with Arrhythmia Prophylaxis and Ventricular Arrhythmia, run by Sanofi at 151 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States, Australia, Canada, France, Poland and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Ventricular Tachycardia or Ventricular Fibrillation (VT/VF) triggered ICD interventions or sudden death (time frame: up to 20 months (median follow-up of 12 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00993382, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.

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