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A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza - NCT01050257-35209(Clinical Trial 465200)



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City:  Birmingham
State:  
AL
Zip Code: 35209
Conditions: Influenza
Purpose: 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.
Study summary:
Criteria: 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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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2010
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