Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

September 25, 2008 updated by: Pfizer

Double-Blind, Placebo-Controlled, Pilot Study, In Medical Patients With Prophylaxis Of Venous Thromboembolism in Primary Care

The primary objective was to study the clinical benefit with dalteparin sodium in thromboprophylaxis in primary care medical subjects. The secondary objective was a pharmacoeconomic evaluation of hromboprophylaxis with dalteparin sodium in primary care medical subjects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study was prematurely terminated on December 9, 2003. The reason for the early termination was not related to a safety or efficacy issue. It was related to the difficulty in recruiting patients.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

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

  • Spain
      • Leon, Spain, 24005
        • Pfizer Investigational Site
      • Madrid, Spain
        • Pfizer Investigational Site
      • Madrid, Spain, 28001
        • Pfizer Investigational Site
      • Parla, Spain
        • Pfizer Investigational Site
      • Torremolinos, Spain, 29620
        • Pfizer Investigational Site

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 65 years
  • Confinement to bed for more than 3 days, due to:
  • Heart failure
  • Exacerbated chronic obstructive pulmonary disease
  • Acute rheumatic involvement
  • Written informed consent

Exclusion Criteria:

  1. Cancer
  2. Anticoagulant treatment in the previous 3 months
  3. Stroke or major surgery in the previous 3 months
  4. Systolic pressure >200 mmHg or diastolic pressure >120 mmHg
  5. Known chronic hepatopathy
  6. Active hemorrhage in any site in the previous 3 months
  7. Active peptic ulcer
  8. Bacterial endocarditis
  9. Conditions that can increase the risk of hemorrhage
  10. Known coagulation disorders
  11. Hypersensitivity to heparin or HIT
  12. Life expectancy of less than 3 months
  13. Previous confinement to bed during more than 3 days

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo was administered with a daily injection of 0.2 mL by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period.
Active Comparator: Dalteparin sodium
Drug: Dalteparin sodium
Dalteparin sodium was administered at a daily dosage of 5,000 UI anti-Xa by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of the endpoint made up of objectively demonstrated deep vein thrombosis (DVT), pulmonary embolism (PE) diagnosed by objective tests or death at the end of the follow-up period, 1 month after the end of the bedridden period.
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and tolerability at the end of the follow-up period.
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

Pfizer

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.

Helpful Links

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

April 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

September 29, 2008

Last Update Submitted That Met QC Criteria

September 25, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGMAEI-0042-046
  • A6301036

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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