Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients - Full Text View

Purpose

To compare the efficacy and safety of dalteparin vs unfractionated heparin for the prevention of VTE (Venous Thromboembolism) in hospitalized acutely ill medical patients.

Condition	Intervention	Phase
Venous Thromboembolism	Drug: Dalteparin (Fragmin) Drug: Unfractionated heparin	Phase IV

ChemIDplus related topics:

Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Composite of objectively confirmed thromboembolic events at day 21 [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of all cause mortality [ Time Frame: Days 14 and 21, ] [ Designated as safety issue: Yes ]
Incidence of stroke either ischemic or hemorrhagic by CT [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Incidence of major and minor bleeding [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Incidence of drug-related allergic reactions and thrombocytopenia [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Verified symptomatic DVT or asymptomatic proximal DVT [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	June 2007
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Dalteparin (Fragmin) Dalteparin 5000 IU once daily subcutaneously for 6-14 days.
B: Active Comparator	Drug: Unfractionated heparin Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.

Detailed Description:

The study was prematurely discontinued due to delay in overall study start-up and inability to meet pre-defined protocol recruitment milestones on June 30th, 2008. There were no safety concerns regarding the study in the decision to terminate the trial.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aged greater than or equal to 18 years
Acute medical condition with a projected hospitalization of greater than or equal to 4 days and had less than or equal to 3 days of prior immobilization for more than two thirds of the day
Acute congestive heart failure Class III-IV per NHYA/ Acute respiratory failure not requiring mechanical ventilation or Both
Acute infection without septic shock/ Acute episode of inflammatory bowel disease/ Acute rheumatologic disorders/ Acute lumbar pain or sciatica or vertebral compression with at least one risk factor for VTE

Exclusion Criteria:

Contraindications to use of anticoagulants
Active bleeding or abnormal coagulation tests
Recent (less than 1 month) head injury, hemorrhagic stroke, cerebral tumor or intracranial aneurysm or ischemic stroke within the last month.
Major surgical or invasive procedure within the last month resulting in ongoing convalescence
Lumbar or spinal puncture within last 48 hours
S creatinine levels more than 2
On inotropic agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445328

Locations


India, Andhra Pradesh
	Pfizer Investigational Site
	Hyderabad, Andhra Pradesh, India, 500 068

India, Gujarat
	Pfizer Investigational Site
	Ahmedabad, Gujarat, India, 380 054

India, Kerala
	Pfizer Investigational Site
	Trichur, Kerala, India, 680 005

India, Madhya Pradesh
	Pfizer Investigational Site
	Indore, Madhya Pradesh, India, 452001

India, Tamil Nadu
	Pfizer Investigational Site
	Chennai, Tamil Nadu, India, 600 006

India, West Bengal
	Pfizer Investigational Site
	Kolkata, West Bengal, India, 700 054
	Pfizer Investigational Site
	Kolkata, West Bengal, India, 700 029

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6301080
First Received:	March 7, 2007
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00445328
Health Authority:	India: Institutional Review Board

Keywords provided by Pfizer:

hospitalised acutely medically ill patients; Venous Thromboembolism, Infection, Inflammatory Bowel Diseases, Heart Failure, Congestive, Sciatica

Study placed in the following topic categories:

Heart Failure

Heparin, Low-Molecular-Weight

Vascular Diseases

Inflammatory Bowel Diseases

Intestinal Diseases

Venous Thromboembolism

Thromboembolism

Thrombosis

Calcium heparin

Sciatica

Embolism and Thrombosis

Dalteparin

Embolism

Heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents

Anticoagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00445328