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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thromboembolism

Intervention: Certoparin (Drug); Unfractionated Heparin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)

Secondary outcome:

proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,

symptomatic DVT,

symptomatic non-fatal pulmonary embolism (PE),

combination of proximal DVT, non fatal PE and death from all causes including PE

VTE related death,

Eligibility

Minimum age: 70 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 longer than 3 days prior to randomization 2. prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system 3. expected major surgical or invasive procedure within the next 3 weeks after randomization 4. LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization 5. immobilization due to cast or fracture 6. indication for anticoagulatory or thrombolytic therapy 7. acute symptomatic DVT / PE 8. known hypersensitivity to any of the study drugs or drugs with similar chemical structures 9. Acute or history of heparin induced thrombocytopenia type II (HIT II) Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis investigative sites, N├╝rnberg, Germany
Additional Information

Starting date: January 2007
Last updated: July 24, 2012

Page last updated: August 23, 2015

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