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Clinical trial

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

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Last updated:1st Dec 2016
Identifier: NCT02949011

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

Category Value
Date last updated at source 2018-05-03
Study type(s) Interventional
Expected enrolment 2157
Study start date 2016-12-01
Estimated primary completion date 2018-04-12

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