Recent Updates
Recently added Catalysts

SR34006

Phase 3

Atrial Fibrillation | Small molecule | Cardiovascular |Sanofi|Last Updated: Apr 6, 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment4,673

FDA Designations

No designations recorded

Clinical trial landscape

SR34006 · 3 trials · 3 indications

Phase 3 3
NCT00071279SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein ThrombosisPulmonary Embolism
COMPLETED1,215 Analytics
NCT00070655Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)Atrial Fibrillation
COMPLETED4,673 Analytics
NCT00062803SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary EmbolismPulmonary Embolism
COMPLETED- Analytics
PHASE3COMPLETED
SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
Pulmonary EmbolismUnlock trial analytics
PHASE3COMPLETED
Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)
Atrial FibrillationUnlock trial analytics
PHASE3COMPLETED
SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism
Pulmonary EmbolismUnlock trial analytics

Study Endpoints

Primary Endpoints

Symptomatic recurrent PE/DVT during the 6-month study treatment period.
Composite of all strokes and non-CNS systemic embolism.
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.

Secondary Endpoints

Major bleeding during the 6-month study treatment period.
Separate components of the primary study outcome.
symptomatic recurrent PE/DVT within 6 months.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE

Interventions

NameTypeDescription
SR34006 (idraparinux sodium) InjectionDRUG -
vitamin K antagonist (warfarin or acenocoumarol) tabletsDRUG -
SR34006DRUG -
(LMW)heparinDRUG -
Warfarin VKADRUG -
Acenocoumarol VKADRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites65

Inclusion Criteria: * Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 for six months * Written informed consent Exclusion Criteria: * Legal age limitations (country specific) * Indication for a...

Countries:United StatesAustraliaAustriaBelgiumBrazilCanadaCzechiaDenmarkFinlandFranceGermanyItalyNetherlandsNew ZealandNorwayPolandSouth AfricaSpainSwedenUnited KingdomArgentinaSwitzerland
Unlock Eligibility Criteria

Frequently asked questions about SR34006

What is SR34006 used for?

SR34006 is an investigational small molecule being developed for cardiovascular conditions, specifically atrial fibrillation and pulmonary embolism. It has been studied in Phase 3 clinical trials for these indications, including use in patients who have completed treatment for symptomatic pulmonary embolism or deep vein thrombosis.

Who makes SR34006?

SR34006 is being developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. The drug has been evaluated in Phase 3 clinical trials for cardiovascular indications.

What phase is SR34006 in?

SR34006 has completed Phase 3 clinical trials. It is an investigational drug that has been studied in trials for atrial fibrillation and pulmonary embolism. The drug is not approved and remains in clinical development.

What clinical trials is SR34006 in?

SR34006 has been studied in three completed Phase 3 trials: NCT00062803 compared it to vitamin K antagonist in pulmonary embolism treatment, NCT00070655 (AMADEUS) evaluated it against warfarin or acenocoumarol in atrial fibrillation patients, and NCT00071279 compared it to placebo after six months of treatment for symptomatic pulmonary embolism or deep vein thrombosis.

Is SR34006 the same as idraparinux?

SR34006 is also known as idraparinux. It is a factor Xa inhibitor being developed by Sanofi for cardiovascular conditions. The drug has been studied in Phase 3 trials for atrial fibrillation and pulmonary embolism.