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Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

This study has been terminated.
(See Detailed Description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00655122
First received: April 4, 2008
Last updated: September 25, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Thromboembolism
Deep Vein Thrombosis
Dalteparin
 Drug: Dalteparin sodium
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Double-Blind, Placebo-Controlled, Pilot Study, In Medical Patients With Prophylaxis Of Venous Thromboembolism in Primary Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: April 2003
Study Completion Date: December 2003
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655122

Locations
Spain
Pfizer Investigational Site
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00655122     History of Changes
Other Study ID Numbers: FGMAEI-0042-046, A6301036
Study First Received: April 4, 2008
Last Updated: September 25, 2008
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dalteparin
Heparin, Low-Molecular-Weight
 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 23, 2013