A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00451412

Purpose

This study is designed to provide efficacy and safety data for certoparin in the prophylaxis of venous thromboembolism in immobilized, acutely ill medical patients.

Condition	Intervention	Phase
Thromboembolism	Drug: Certoparin Drug: unfractionated heparin	Phase III

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Multi-Center Comparison of the Efficacy and Safety of Certoparin (3000 U Anti-Xa o.d.) With Unfractionated Heparin (5000 IU t.i.d.) in the Prophylaxis of Thromboembolic Events in Acutely Ill Medical Patients

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) [ Time Frame: 20 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening, [ Time Frame: 20 days ] [ Designated as safety issue: No ]
symptomatic DVT, [ Time Frame: 20 days ] [ Designated as safety issue: No ]
symptomatic non-fatal pulmonary embolism (PE), [ Time Frame: 20 days ] [ Designated as safety issue: No ]
combination of proximal DVT, non fatal PE and death from all causes including PE [ Time Frame: 20 days ] [ Designated as safety issue: No ]
VTE related death, [ Time Frame: 20 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	3200
Study Start Date:	January 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Certoparin 3000 U anti XA of certoparin in 0.3 ml solution, once daily
2: Active Comparator	Drug: unfractionated heparin solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hospitalized medical patients 70 years of age or older
Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
written informed consent

Exclusion Criteria:

immobilization longer than 3 days prior to randomization
prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
expected major surgical or invasive procedure within the next 3 weeks after randomization
LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
immobilization due to cast or fracture
indication for anticoagulatory or thrombolytic therapy
acute symptomatic DVT / PE
known hypersensitivity to any of the study drugs or drugs with similar chemical structures
Acute or history of heparin induced thrombocytopenia type II (HIT II)

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451412

Contacts

Contact: Novartis

+41 61 324 1111

Locations

Germany
Novartis investigative sites	Recruiting
Nürnberg, Germany
Contact: Novartis +41 61 324 1111
Principal Investigator: Novartis

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CMEX839BDE03
Study First Received:	March 21, 2007
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00451412
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Romania: National Medicines Agency

Keywords provided by Novartis:

Venous thromboembolism
Medical patients
Heparin
Low molecular weight heparin

Deep vein thrombosis
Certoparin
Embolism and Thrombosis

Study placed in the following topic categories:

Heparin, Low-Molecular-Weight
Vascular Diseases
Venous Thromboembolism
Thrombosis
Thromboembolism
Calcium heparin
Body Weight

Calcium, Dietary
Embolism and Thrombosis
Embolism
Venous Thrombosis
Heparin
Certoparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009