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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00451412
First received: March 21, 2007
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  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 3

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 3254
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Certoparin Drug: Certoparin
3000 U anti XA of certoparin in 0.3 ml solution, once daily
Other Names:
  • Sandoparin
  • Embolex
  • low molecular weight heparin
Active Comparator: Unfractionated Heparin 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:

  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

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

Locations
Germany
Novartis investigative sites
Nürnberg, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00451412     History of Changes
Other Study ID Numbers: CMEX839BDE03
Study First Received: March 21, 2007
Last Updated: July 24, 2012
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

Additional relevant MeSH terms:
Thromboembolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Calcium heparin
Certoparin
Heparin
Heparin, Low-Molecular-Weight
 Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013