Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00655122

Purpose

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	Intervention	Phase
Thromboembolism Deep Vein Thrombosis Dalteparin	Drug: Dalteparin sodium Drug: Placebo	Phase IV

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind, Placebo-Controlled, Pilot Study, In Medical Patients With Prophylaxis Of Venous Thromboembolism in Primary Care

Further study details as provided by Pfizer:

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. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	8
Study Start Date:	April 2003
Study Completion Date:	December 2003

Arms	Assigned Interventions
Dalteparin sodium: Active Comparator	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: Placebo Comparator	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.

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655122

Locations

Spain
Pfizer Investigational Site
Parla, Spain
Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
Leon, Spain, 24005
Pfizer Investigational Site
Torremolinos, Spain, 29620
Pfizer Investigational Site
Madrid, Spain, 28001

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	FGMAEI-0042-046, A6301036
Study First Received:	April 4, 2008
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00655122 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Anticoagulants
Heparin, Low-Molecular-Weight
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Venous Thromboembolism
Thrombosis

Thromboembolism
Embolism and Thrombosis
Fibrin Modulating Agents
Embolism
Dalteparin
Venous Thrombosis

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Venous Thromboembolism
Thromboembolism

Thrombosis
Pharmacologic Actions
Embolism and Thrombosis
Fibrin Modulating Agents
Dalteparin
Therapeutic Uses
Venous Thrombosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009