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Certoparin

Phase 3

Thromboembolism | Small molecule | Other |Novartis AG|Last Updated: Jul 25, 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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment3,254
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00451412A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical PatientsPHASE3 COMPLETED 3,254Jan 1, 2007Jun 1, 2009Jul 25, 20121 Germany
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Study Endpoints
Primary Endpoints
Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)
20 days
Secondary Endpoints
proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,
20 days
symptomatic DVT,
20 days
symptomatic non-fatal pulmonary embolism (PE),
20 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
CertoparinEXPERIMENTAL -
Unfractionated HeparinACTIVE_COMPARATOR -
Interventions
NameTypeDescription
CertoparinDRUG3000 U anti XA of certoparin in 0.3 ml solution, once daily
Unfractionated HeparinDRUGsolution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily
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Eligibility Criteria
Age Range70 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Hospitalized medical patients 70 years of age or older 2. Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances) 3. written informed consent Exclusion Criteria: 1. immobilization long...

Countries:Germany
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