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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00445328 |
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. |
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.
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A: Experimental |
Drug: Dalteparin (Fragmin)
Dalteparin 5000 IU once daily subcutaneously for 6-14 days.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6301080 |
Study First Received: | March 7, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00445328 |
Health Authority: | India: Institutional Review Board |
hospitalised acutely medically ill patients; Venous Thromboembolism, Infection, Inflammatory Bowel Diseases, Heart Failure, Congestive, Sciatica |
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 |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |