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Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

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ClinicalTrials.gov Identifier: NCT00655122
Recruitment Status : Terminated (See Detailed Description.)
First Posted : April 9, 2008
Last Update Posted : September 29, 2008
Sponsor:
Information provided by:
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Thromboembolism Deep Vein Thrombosis Dalteparin Drug: Dalteparin sodium Drug: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Double-Blind, Placebo-Controlled, Pilot Study, In Medical Patients With Prophylaxis Of Venous Thromboembolism in Primary Care
Study Start Date : April 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655122


Locations
Spain
Pfizer Investigational Site
Leon, Spain, 24005
Pfizer Investigational Site
Madrid, Spain, 28001
Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
Parla, Spain
Pfizer Investigational Site
Torremolinos, Spain, 29620
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00655122     History of Changes
Other Study ID Numbers: FGMAEI-0042-046
A6301036
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: September 29, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action