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

March 21, 2007
July 24, 2012
January 2007
June 2009   (final data collection date for primary outcome measure)
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 ]
Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)
Complete list of historical versions of study NCT00451412 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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,
Not Provided
Not Provided
 
A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Thromboembolism
  • Drug: Certoparin
    3000 U anti XA of certoparin in 0.3 ml solution, once daily
    Other Names:
    • Sandoparin
    • Embolex
    • low molecular weight heparin
  • Drug: Unfractionated Heparin
    solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily
  • Experimental: Certoparin
    Intervention: Drug: Certoparin
  • Active Comparator: Unfractionated Heparin
    Intervention: Drug: Unfractionated Heparin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3254
June 2009
June 2009   (final data collection date for primary outcome measure)

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

Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00451412
CMEX839BDE03
No
Novartis
Novartis
Not Provided
Study Director: Novartis Novartis
Novartis
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP