CLINICAL TRIALS PROFILE FOR OSELTAMIVIR PHOSPHATE
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All Clinical Trials for OSELTAMIVIR PHOSPHATE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00416962 ↗ | Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine | Completed | Hoffmann-La Roche | Phase 1 | 2006-08-01 | This study is designed to assess the safety and pharmacokinetic effects of oseltamivir administration alone or in combination with amantadine in healthy volunteers. |
| NCT00416962 ↗ | Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine | Completed | Novartis | Phase 1 | 2006-08-01 | This study is designed to assess the safety and pharmacokinetic effects of oseltamivir administration alone or in combination with amantadine in healthy volunteers. |
| NCT00453999 ↗ | Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza | Completed | BioCryst Pharmaceuticals | Phase 2 | 2007-07-01 | This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days. |
| NCT00803595 ↗ | A Multinational Phase III Study of CS-8958 (MARVEL) | Completed | Daiichi Sankyo Co., Ltd. | Phase 3 | 2008-11-01 | The primary objective of this study is to confirm the efficacy of CS-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. For safety evaluation, between-group comparisons will be made with regard to incidence of adverse events and other safety measures. In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose. |
| NCT00979251 ↗ | Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects | Completed | Adamas Pharmaceuticals, Inc. | Phase 2 | 2009-09-01 | This Phase 2, open label, randomized study will investigate the virologic benefit, clinical efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (TCAD) versus oseltamivir monotherapy for the treatment of all strains of influenza A in immunocompromised adult and pediatric subjects. |
| NCT01010087 ↗ | Trial Comparing High Versus Standard Dose Oseltamivir in Severe Influenza Infection in ICU | Terminated | Hoffmann-La Roche | Phase 2 | 2009-11-01 | Primary Objectives: The primary objective of the trial is to compare the antiviral efficacy of a 10 day course of standard (75 mg bid) and high-dose (225 mg bid) oseltamivir (or equivalent doses in mild-moderate renal failure) in the treatment of severe influenza infections. The hypothesis is that high dose oseltamivir will increase the proportion of patients with negative reverse transcriptase (RT)-PCR detection of influenza viral RNA (and viral culture, at selected sites) at Day 5 post-treatment. An important secondary objective of the trial, which reflects the main clinical objective, is to determine the difference in the numbers of ventilator days between the standard-dose and high-dose groups |
| NCT01010087 ↗ | Trial Comparing High Versus Standard Dose Oseltamivir in Severe Influenza Infection in ICU | Terminated | University of Manitoba | Phase 2 | 2009-11-01 | Primary Objectives: The primary objective of the trial is to compare the antiviral efficacy of a 10 day course of standard (75 mg bid) and high-dose (225 mg bid) oseltamivir (or equivalent doses in mild-moderate renal failure) in the treatment of severe influenza infections. The hypothesis is that high dose oseltamivir will increase the proportion of patients with negative reverse transcriptase (RT)-PCR detection of influenza viral RNA (and viral culture, at selected sites) at Day 5 post-treatment. An important secondary objective of the trial, which reflects the main clinical objective, is to determine the difference in the numbers of ventilator days between the standard-dose and high-dose groups |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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