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

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

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
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:

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


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

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

Novartis investigative sites
Nürnberg, Germany
Sponsors and Collaborators
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
Low molecular weight heparin
Deep vein thrombosis
Embolism and Thrombosis

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

ClinicalTrials.gov processed this record on April 20, 2014