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

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

Purpose

The purpose of this study is 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

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.

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Confirmed Thromboembolic Events [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Composite of Objectively Verified Thromboembolic Events [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

All Cause Mortality [ Time Frame: Day 14, Day 21 (End of Study) ] [ Designated as safety issue: Yes ]
Stroke - Ischemic or Hemorrhagic [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Bleeding - Major or Minor [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Allergic Reactions (Drug-related) [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Thrombocytopenia [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Enrollment:	84
Study Start Date:	June 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

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

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:	A6301080
Study First Received:	March 7, 2007
Results First Received:	July 20, 2009
Last Updated:	October 5, 2009
ClinicalTrials.gov Identifier:	NCT00445328 History of Changes
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

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Heparin, Low-Molecular-Weight
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Venous Thromboembolism
Pharmacologic Actions

Thromboembolism
Thrombosis
Calcium heparin
Embolism and Thrombosis
Fibrin Modulating Agents
Dalteparin
Therapeutic Uses
Cardiovascular Diseases
Heparin

ClinicalTrials.gov processed this record on November 27, 2009