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Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thromboembolism; Deep Vein Thrombosis; Dalteparin

Intervention: Dalteparin sodium (Drug); Placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: 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.

Secondary outcome: Incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and tolerability at the end of the follow-up 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

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Pfizer Investigational Site, Leon 24005, Spain

Pfizer Investigational Site, Madrid 28001, Spain

Pfizer Investigational Site, Madrid, Spain

Pfizer Investigational Site, Parla, Spain

Pfizer Investigational Site, Torremolinos 29620, Spain

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: April 2003
Last updated: September 25, 2008

Page last updated: August 20, 2015

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