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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Thromboembolism

Intervention: Dalteparin (Fragmin) (Drug); Unfractionated heparin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Confirmed Thromboembolic Events

Composite of Objectively Verified Thromboembolic Events

Secondary outcome:

All Cause Mortality

Stroke - Ischemic or Hemorrhagic

Bleeding - Major or Minor

Allergic Reactions (Drug-related)


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- Lumbar or spinal puncture within last 48 hours

- S creatinine levels more than 2

- On inotropic agents

Locations and Contacts

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

Pfizer Investigational Site, Ahmedabad, Gujarat 380 054, India

Pfizer Investigational Site, Trichur, Kerala 680 005, India

Pfizer Investigational Site, Indore, Madhya Pradesh 452001, India

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

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

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

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: June 2007
Last updated: October 5, 2009

Page last updated: August 20, 2015

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