Back to resultsProphylaxis In Venous Thromboembolism In Primary Care, A Pilot Study
Primary Purpose
Thromboembolism, Deep Vein Thrombosis, Dalteparin
Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Dalteparin sodium
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Thromboembolism
Eligibility 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:
- Cancer
- Anticoagulant treatment in the previous 3 months
- Stroke or major surgery in the previous 3 months
- Systolic pressure >200 mmHg or diastolic pressure >120 mmHg
- Known chronic hepatopathy
- Active hemorrhage in any site in the previous 3 months
- Active peptic ulcer
- Bacterial endocarditis
- Conditions that can increase the risk of hemorrhage
- Known coagulation disorders
- Hypersensitivity to heparin or HIT
- Life expectancy of less than 3 months
- Previous confinement to bed during more than 3 days
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dalteparin sodium
Placebo
Arm Description
Outcomes
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.
Secondary Outcome Measures
Incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and tolerability at the end of the follow-up period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00655122
Brief Title
Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study
Official Title
Double-Blind, Placebo-Controlled, Pilot Study, In Medical Patients With Prophylaxis Of Venous Thromboembolism in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Terminated
Why Stopped
See Detailed Description.
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism, Deep Vein Thrombosis, Dalteparin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dalteparin sodium
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dalteparin sodium
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Cancer
Anticoagulant treatment in the previous 3 months
Stroke or major surgery in the previous 3 months
Systolic pressure >200 mmHg or diastolic pressure >120 mmHg
Known chronic hepatopathy
Active hemorrhage in any site in the previous 3 months
Active peptic ulcer
Bacterial endocarditis
Conditions that can increase the risk of hemorrhage
Known coagulation disorders
Hypersensitivity to heparin or HIT
Life expectancy of less than 3 months
Previous confinement to bed during more than 3 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Leon
ZIP/Postal Code
24005
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28001
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
Country
Spain
Facility Name
Pfizer Investigational Site
City
Parla
Country
Spain
Facility Name
Pfizer Investigational Site
City
Torremolinos
ZIP/Postal Code
29620
Country
Spain
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=FGMAEI-0042-046&StudyName=Prophylaxis%20In%20Venous%20Thromboembolism%20In%20Primary%20Care%2C%20A%20Pilot%20Study
Description
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Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study
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