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SR34006

Phase 3

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

SR34006 development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Jun 2003

SR34006 target and mechanism

ModalitySmall molecule

Also known as SR34006 (idraparinux sodium) Injection, Idraparinux sodium

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment5,888

FDA Designations

No designations recorded

SR34006 clinical trials

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.
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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 -
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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
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Competitive Landscape -Atrial Fibrillation 159 trials

Frequently asked questions about SR34006

What is SR34006?

SR34006 is an investigational small molecule anticoagulant developed by Sanofi. It has been studied in Phase 3 clinical trials for cardiovascular conditions, specifically atrial fibrillation and pulmonary embolism. It is also known as idraparinux sodium and is given as an injection.

What is SR34006 used for?

SR34006 has been studied for the treatment and prevention of thromboembolic conditions, including atrial fibrillation and pulmonary embolism. Clinical trials evaluated it in patients with atrial fibrillation and in patients with symptomatic pulmonary embolism or deep vein thrombosis. It is investigational and not approved for commercial use.

Who makes SR34006?

SR34006 is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 3 clinical program evaluating the drug in atrial fibrillation and pulmonary embolism.

What phase is SR34006 in?

SR34006 reached Phase 3 clinical development. Two completed Phase 3 trials are registered, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is SR34006 in?

SR34006 was evaluated in Phase 3 trials including NCT00070655, the AMADEUS study comparing it to warfarin or acenocoumarol in atrial fibrillation, NCT00071279 comparing it to placebo after six months of treatment for pulmonary embolism or deep vein thrombosis, and NCT00062803 comparing it to a vitamin K antagonist in pulmonary embolism.

Is SR34006 the same as idraparinux sodium?

Yes, SR34006 is also known as idraparinux sodium. The full name used in study listings is SR34006 (idraparinux sodium) Injection. Both names refer to the same investigational Sanofi anticoagulant studied in Phase 3 trials for atrial fibrillation and pulmonary embolism.