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CELIVARONE

Phase 2

Atrial Fibrillation | Small molecule | Cardiovascular |Sanofi|Last Updated: May 8, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment823
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00232310Double Blind Placebo COntrolled Dose Ranging studY of the eFficacy and safEty of SSR149744c 300 or 600 mg for the Conversion of Atrial Fibrillation / fluttErPHASE2 COMPLETED 150 — — Oct 1, 2005Apr 1, 2006May 8, 20129 United States, Canada +7
NCT00233441Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/FlutterPHASE2 COMPLETED 673 — — Dec 1, 2004May 1, 2006May 8, 201217 United States, Argentina +15
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Study Endpoints
Primary Endpoints
The primary efficacy endpoint is the rate of conversion to sinus rhythm documented by ECG just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.
The primary endpoint is the time from randomization to first documented AF/AFL recurrence indicated by 12-lead ECG or trans-telephonic ECG monitoring tracings showing AF/AFL.
Secondary Endpoints
The secondary efficacy endpoint will be the mean ventricular rate during AF/AFL on the 12-lead ECG performed just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.
The secondary endpoints will be the following:time from randomization to first symptomatic AF/AFL recurrence - mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CELIVARONE (SSR149744C)DRUG -
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * AF/AFL for \>72 hours and documented by 2 12-lead ECGs separated by at least 72 hours and indication for electrical cardioversion of the current AF/AFL episode as judged by the investigator. Exclusion Criteria: MAIN CRITERIA (non-exhaustive list): * Women of childbearing po...

Countries:United StatesCanadaCzechiaFranceGermanyHungaryItalyNetherlandsPortugalArgentinaAustraliaChileDenmarkJapanPolandRussiaSpainSwedenSwitzerland
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Competitive Landscape -Atrial Fibrillation 104 trials
CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN2PHASE3REGN7508, REGN9933, Apixaban
Johnson & JohnsonJNJ2PHASE3Milvexian, Apixaban
Novartis AG Sponsored ADRNVS1PHASE2PKN605
Milestone Pharmaceuticals, Inc.MIST1PHASE3Etripamil
Boston Scientific CorporationBSX22NANon-Vitamin K Anticoagulant, Anti-Arrhythmic Drug : Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone
Abbott LaboratoriesABT9 — Non-Vitamin K Antagonists
HeartSciences Inc.HSCS1PHASE3Undisclosed
AtriCure, Inc.ATRC5NAUndisclosed
Rhythm Pharmaceuticals, Inc.RYTM9 — Undisclosed
Pulse Biosciences, Inc.PLSE4NAUndisclosed
Haemonetics CorporationHAE1NAUndisclosed
Medtronic PlcMDT6 — Undisclosed
Pfizer Inc.PFE1 — Apixaban, Rivaroxaban, Dabigatran, Vitamin K antagonist
AstraZeneca PLCAZN1NAUndisclosed
HeartBeam, Inc.BEAT1 — Undisclosed
Healthcare Services Group, Inc.HCSG1 — Undisclosed
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