Overview

A Multinational Phase III Study of CS-8958 (MARVEL)

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Treatments:
Oseltamivir