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

July 24, 2012 updated by: Novartis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3254

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Nürnberg, Germany
        • Novartis Investigative Sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Certoparin
Drug: Certoparin
3000 U anti XA of certoparin in 0.3 ml solution, once daily
Other Names:
  • low molecular weight heparin
  • Sandoparin
  • Embolex
ACTIVE_COMPARATOR: Unfractionated Heparin
Drug: Unfractionated Heparin
solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)
Time Frame: 20 days
20 days

Secondary Outcome Measures

Outcome Measure
Time Frame
proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,
Time Frame: 20 days
20 days
symptomatic DVT,
Time Frame: 20 days
20 days
symptomatic non-fatal pulmonary embolism (PE),
Time Frame: 20 days
20 days
combination of proximal DVT, non fatal PE and death from all causes including PE
Time Frame: 20 days
20 days
VTE related death,
Time Frame: 20 days
20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

March 21, 2007

First Submitted That Met QC Criteria

March 22, 2007

First Posted (ESTIMATE)

March 23, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMEX839BDE03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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