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Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Leon, , 24005 Spain
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Thromboembolism, Deep Vein Thrombosis, Dalteparin
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00655122
Pfizer
Terminated
Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

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Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
  • Thromboembolism
  • Deep Vein Thrombosis
  • Dalteparin
  • 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.
  • 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
    Intervention: Drug: Dalteparin sodium
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
December 2003
Not Provided

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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00655122
FGMAEI-0042-046
A6301036
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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