Prophylaxis In Venous Thromboembolism In Primary Care, A... | NCT00655122

Studies
Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

NCT00655122

Sponsor

Pfizer

Status

Terminated

Last Update Posted

Sep 29, 2008Estimated

Enrollment

8Actual

Phase

Phase 4

Conditions

Thromboembolism
Deep Vein Thrombosis
Dalteparin

Interventions

Dalteparin sodium
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
A6301036

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

See Detailed Description.

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Dec 2003Actual

First Submitted Date

Apr 4, 2008

First Submission Date that Met QC Criteria

Apr 4, 2008

First Posted Date

Apr 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2008

Last Update Posted Date

Sep 29, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dalteparin sodium	Active Comparator		Drug: Dalteparin sodium
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dalteparin sodium	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		León		24005	Spain
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

Condition Browse Module

MeSH Terms

ID	Term
D013923	Thromboembolism
D020246	Venous Thrombosis

Ancestor Terms

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D013927	Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017985	Dalteparin

Ancestor Terms

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides

Browse Leaves

Not provided

Browse Branches

Not provided