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Investigation Into the Therapeutic Dosage of Fondaparinux Sodium, a Medication Used to Prevent Blood Clots in Morbidly Obese Volunteers
NCT00436787 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00436787
The ClinicalTrials.gov registry entry for NCT00436787 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,082 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00436787 reports 2 study locations spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00436787?
The interventions under investigation include: Fondaparinux Sodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00436787?
This trial is sponsored by University of Pittsburgh, which has 1,082 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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