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NCT00436787 · ClinicalTrials.gov registry record · Phase 2
Investigation Into the Therapeutic Dosage of Fondaparinux Sodium, a Medication Used to Prevent Blood Clots in Morbidly Obese Volunteers
A Phase 2 study of Pulmonary Embolism and Venous Thrombosis, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 2
- Study locations
NCT00436787: Completed Phase 2 study of Pulmonary Embolism and Venous Thrombosis, sponsored by University of Pittsburgh.
NCT00436787 is a Phase 2 study of Pulmonary Embolism and Venous Thrombosis that has completed, run by University of Pittsburgh. The registered enrollment target is 21 participants, below the 3,058-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00436787, a Phase 2 study of Pulmonary Embolism and Venous Thrombosis, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 2
- Study locations
Study Summary
Morbidly obese individuals are at high risk for potentially life threatening blood clots around the time of abdominal surgical procedures. Fondaparinux sodium (Arixtra) is an FDA- approved medication used in the prevention of deep venous thrombosis (DVT) at the time of orthopedic or abdominal surgery, as well as for the treatment of DVT and pulmonary embolism (PE). As with many medications, therapeutic dosages have not been fully investigated for the morbidly obese population. Our goal is to study the therapeutic blood levels, after 2 different dosages of the medication are given to morbidly obese volunteers. We will recruit 21 morbidly obese (Body Mass Index (BMI) \> 35) individuals who are in the evaluation process for bariatric surgery. They will be divided into 7 groups: 3 participants with BMI 35 - 39.9, 3 with a BMI of 40 - 49.9, 3 with a BMI of 50 - 59.9, 3 with a BMI \> 60, 3 with a weight of 100 - 149 KG, 3 with a weight of 150 - 199 KG and 3 with a weight of 200 - 249 KG. Participants will be administered two different doses of the medication with a 2-week interval in between, then blood will be drawn in various intervals throughout the next 48 hours to see which dose provides the best therapeutic levels. Participants will be monitored closely for any side effects or complications.
Conditions Studied
Interventions
- DRUG Fondaparinux Sodium
Study Locations (2)
Pennsylvania
- Magee Women's Hospital - Pittsburgh
- Shadyside Medical Building - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2007-02 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
What the finished NCT00436787 record still lists
NCT00436787 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 3,058-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Pulmonary Embolism appearing as the primary indexed condition, and to 1 intervention - of which Fondaparinux Sodium is the first listed.
NCT00436787 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00436787 about?
NCT00436787 is a clinical study titled "Investigation Into the Therapeutic Dosage of Fondaparinux Sodium, a Medication Used to Prevent Blood Clots in Morbidly Obese Volunteers". Morbidly obese individuals are at high risk for potentially life threatening blood clots around the time of abdominal surgical procedures. Fondaparinux sodium (Arixtra) is an FDA- approved medication used in the prevention of deep venous thrombosis (DVT) at the time of orthopedic or abdominal surger...
What is the current status of trial NCT00436787?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2007-02. Estimated completion is 2007-12.
What conditions does trial NCT00436787 study?
This clinical trial studies the following conditions: Pulmonary Embolism, Venous Thrombosis.
What interventions are being tested in trial NCT00436787?
The interventions under investigation include: Fondaparinux Sodium (DRUG).
Who is sponsoring clinical trial NCT00436787?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00436787 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00436787's enrollment target sits among peer trials
21 47th of 48 higher than 2 of 48 other Pulmonary Embolism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Embolism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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