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| Sponsored by: |
Pfizer |
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00445328 |
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 |
| 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. |
| 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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |||||
| Pfizer |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
To obtain contact information for a study center near you, click here. 
  |
| 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 |
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