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Certoparin

Phase 3

Embolism | Small molecule | Cardiovascular |Novartis AG|Last Updated: Feb 24, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment342

FDA Designations

No designations recorded

Clinical trial landscape

Certoparin · 4 trials · 4 indications

Phase 3 4
NCT01179620Certoparin in Renal Patients Undergoing HemodialysisRenal Dialysis
COMPLETED109 Analytics
NCT00451412A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical PatientsThromboembolism
COMPLETED3,254 Analytics
NCT00311753Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical PatientsEmbolism
COMPLETED342 Analytics
NCT00171769Atrial Fibrillation Feasibility Certoparin Trial - AFFECTPersistent Nonvalvular Atrial Fibrillation
COMPLETED200 Analytics
PHASE3COMPLETED
Certoparin in Renal Patients Undergoing Hemodialysis
Renal DialysisUnlock trial analytics
PHASE3COMPLETED
A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients
ThromboembolismUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients
EmbolismUnlock trial analytics
PHASE3COMPLETED
Atrial Fibrillation Feasibility Certoparin Trial - AFFECT
Persistent Nonvalvular Atrial FibrillationUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of patients requiring uptitration
Week 8
Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)
20 days
The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment
10 ± 2 days
Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events

Secondary Endpoints

Pharmacokinetics of Certoparin
Day 1, Week 4
Safety and tolerability of Certoparin
8 weeks
proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,
20 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
CertoparinEXPERIMENTAL -
Unfractionated HeparinACTIVE_COMPARATOR -
1EXPERIMENTALCertoparin
2ACTIVE_COMPARATORHeparin

Interventions

NameTypeDescription
CertoparinDRUGCertoparin
Unfractionated HeparinDRUGsolution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily
HeparinDRUG7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Patients requiring hemodialysis * Patients requiring anticoagulation therapy during hemodialysis * Written informed consent Exclusion Criteria: * Hypersensitivity to study medication * Genetic abnormality or disease of clotting system * Prior major surgery or bleeding * Othe...

Countries:GermanySwitzerlandUnited States
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Competitive Landscape -Pulmonary Embolism 6 trials (matched to "Embolism")

Frequently asked questions about Certoparin

What is Certoparin used for?

Certoparin is an investigational small molecule being studied for cardiovascular conditions including persistent nonvalvular atrial fibrillation, thromboembolism, renal dialysis, and renal insufficiency. It is a low-molecular-weight heparin evaluated for thromboprophylaxis in acutely ill medical patients and for use in renal patients undergoing hemodialysis.

Who makes Certoparin?

Certoparin is being developed by Novartis AG, a multinational pharmaceutical company listed on the NYSE under the ticker NVS. The drug is currently in clinical development for cardiovascular indications.

What phase is Certoparin in?

Certoparin is in Phase 3 clinical development. It has completed Phase 3 trials for persistent nonvalvular atrial fibrillation, embolism, and renal dialysis, as well as a Phase 1 pharmacokinetic study in renal insufficiency. It remains investigational and is not approved.

What clinical trials is Certoparin in?

Certoparin has completed several clinical trials. NCT00171769, the AFFECT trial, studied it in persistent nonvalvular atrial fibrillation. NCT00311753 evaluated it for thromboprophylaxis in acutely ill medical patients with embolism. NCT01179620 tested it in renal patients undergoing hemodialysis, and NCT01660295 examined its pharmacokinetics in renal insufficiency.

Is Certoparin the same as a low-molecular-weight heparin?

Certoparin is a low-molecular-weight heparin, as indicated in the title of one of its clinical trials. It is being studied for its efficacy and safety in preventing thromboembolism in various patient populations, including those with atrial fibrillation and renal impairment.