Study Stopped
See Detailed Description.
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
2 other identifiers
interventional
8
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2003
Shorter than P25 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 9, 2008
CompletedSeptember 29, 2008
September 1, 2008
April 4, 2008
September 25, 2008
Conditions
Outcome Measures
Primary Outcomes (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.
1 month
Secondary Outcomes (1)
Incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and tolerability at the end of the follow-up period.
1 month
Study Arms (2)
Dalteparin sodium
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (5)
Pfizer Investigational Site
León, 24005, Spain
Pfizer Investigational Site
Madrid, 28001, Spain
Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
Parla, Spain
Pfizer Investigational Site
Torremolinos, 29620, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 9, 2008
Study Start
April 1, 2003
Study Completion
December 1, 2003
Last Updated
September 29, 2008
Record last verified: 2008-09