A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain - NCT01032837-29464 (Clinical Trial 478372)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy478372.aspx
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| City: |
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Mt. Pleasant |
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State:
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SC |
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29464 |
| Conditions: |
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Influenza |
| Purpose: |
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This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the
efficacy against viral activity, the effectiveness in resolving the disease symptoms, and
the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza
strain or influenza A are eligible for this study. Patients will be randomized to one of
four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg
(adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body
weight-adjusted for pediatric patients. The target sample size is 300-500 patients.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Pediatric, adolescent and adult patients >/=1 year of age
- Fever >/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore
throat, or rhinitis)
- Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the
24 hours prior to the first dose of study drug
- </=96 hours between onset of influenza-like illness and first dose of oseltamivir
Exclusion Criteria:
- Currently receiving any form of renal replacement therapy including hemodialysis,
peritoneal dialysis, or hemofiltration
- History of chronic renal failure or clinical suspicion of renal failure at baseline
- Clinical evidence of hepatic compensation at the time of randomization
- Known HIV infection
- Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to
first dose of study medication |
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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 |
Modifications to
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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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