Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

NCT00655122

Last updated date
Study Location
Pfizer Investigational Site
Leon, , 24005, Spain
Contact
1-800-718-1021

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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

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Thromboembolism, Deep Vein Thrombosis, DalteparinProphylaxis In Venous Thromboembolism In Primary Care, A Pilot Study NCT00655122
  1. Leon,
  2. Madrid,
  3. Madrid,
  4. Parla,
  5. Torremolinos,
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study
Official Title  ICMJE Double-Blind, Placebo-Controlled, Pilot Study, In Medical Patients With Prophylaxis Of Venous Thromboembolism in Primary Care
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Thromboembolism
  • Deep Vein Thrombosis
  • Dalteparin
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Dalteparin sodium
    Intervention: Drug: Dalteparin sodium
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 4, 2008)
8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00655122
Other Study ID Numbers  ICMJE FGMAEI-0042-046
A6301036
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP