NCT04730037 - Clinical Trial to Investigate Safety and Efficacy of Edoxaban in Patients With CTEPH (KABUKI) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 23, 2021

Primary Completion Date

March 30, 2023

Study Completion Date

June 27, 2023

Conditions

CTEPH

Interventions

DRUG

Edoxaban

\- Edoxaban 30 mg/60 mg tablet according to body weight. 60 kg or less: 30 mg once daily, over 60 kg: 60 mg once daily, reduced to 30 mg once daily depending on renal function and concomitant medications

DRUG

Warfarin Potassium

\- Warfarin K 1 mg tablets once daily (Dose adjusted with target PT-INR of 1.5-2.5)

DRUG

Warfarin Potassium placebo

\- Warfarin K 1 mg placebo tablets once daily

DRUG

Edoxaban placebo

\- Edoxaban 30 mg/60 mg placebo tablet according to body weight. 60 kg or less: 30 mg once daily, over 60 kg: 60 mg once daily, reduced to 30 mg once daily depending on renal function and concomitant medications

Trial Locations (1)

812-8582

Kyushu University Hospital, Fukuoka