NCT04730037

Clinical Trial to Investigate Safety and Efficacy of Edoxaban in Patients With CTEPH (KABUKI)

An Investigator-initiated, Multicenter, Phase 3, Randomized, Single-blind, Double-dummy, Parallel-group Study of Evaluate the Efficacy and Safety of Edoxaban Versus Warfarin (Vitamin K Antagonist) in Subjects With Chronic Thromboembolic Pulmonary Hypertension Taking Warfarin (Vitamin K Antagonist) at Baseline: KABUKI

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Kyushu University · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is phase III trial to evaluate whether edoxaban, a direct factor Xa inhibitor, is noninferior to warfarin in preventing worsening of chronic thromboembolic pulmonary hypertension (CTEPH).

Conditions

• CTEPH

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-23
• Primary completion: 2023-03-30
• Completion: 2023-06-27
• First posted: 2021-01-29
• Last updated: 2023-10-05

Locations

1 site across 1 country: Japan