Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications (CAPSTONE 2)

The primary objective of this study is to evaluate the efficacy of a single, oral dose of Baloxavir Marboxil compared with placebo by measuring the time to improvement of influenza symptoms in patients with influenza presenting within 48 hours of symptom onset.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 2157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Patients With Influenza at High Risk of Influenza Complications
Actual Study Start Date: December 1, 2016
Actual Primary Completion Date: April 12, 2018
Actual Study Completion Date: April 20, 2018

Arm:
- Experimental: Baloxavir Marboxil
- Active Comparator: Oseltamivir
- Placebo Comparator: Placebo