A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza - NCT01050257-72205 (Clinical Trial 465203)
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| City: |
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Little Rock |
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AR |
| Zip Code: |
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72205 |
| Conditions: |
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Influenza |
| Purpose: |
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This randomized, multi-center parallel-group study will evaluate the safety,
pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in
patients with influenza. Adult and adolescent patients will be randomized to receive either
100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are
blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral
Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days,
with an optional treatment extension, if necessary. The target sample size is 200-300
patients.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Adult and adolescent patients, 13 years of age and older
- Diagnosis of influenza
- </=96 hours between the onset of influenza-like illness and first dose of study drug
Exclusion Criteria:
- Clinical evidence of severe hepatic decompensation at the time of randomization
- Acute ischemia or significant arrhythmia
- Creatinine clearance <30 mL/min |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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