Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

Sponsor

Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00655122

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Apr 1, 2003

Actual Study Completion Date :

Dec 1, 2003

Arms and Interventions

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.

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.

Outcome Measures

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. [1 month]

Secondary Outcome Measures

Incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and tolerability at the end of the follow-up period. [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Pfizer Investigational Site	Leon	Spain	24005
2	Pfizer Investigational Site	Madrid	Spain	28001
3	Pfizer Investigational Site	Madrid	Spain
4	Pfizer Investigational Site	Parla	Spain
5	Pfizer Investigational Site	Torremolinos	Spain	29620