88. 慢性血栓塞栓性肺高血圧症 Chronic thromboembolic pulmonary hypertension Clinical trials / Disease details


臨床試験数 : 159 薬物数 : 118 - (DrugBank : 23) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 53

  
3 trials found
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1JPRN-jRCT2071200098
09/04/202108/02/2021Phase III Investigator-Initiated Trial to Investigate Safety and Efficacy of Edoxaban in Patients with Chronic Thromboembolic Pulmonary HypertensionAn Investigator-initiated, multicenter, phase 3, randomized, single-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of edoxaban versus warfarin (Vitamin K antagonist) in subjects with chronic thromboembolic pulmonaty hypertension taking warfarin (Vitamin K antagonist) at baseline - KABUKI Chronic Thromboembolic Pulmonary Hypertension
CTEPH, DOAC, warfarin
Oral administeration of (1) or (2)
(1) Edoxaban group
- 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)

- Warfarin K 1 mg placebo tablets once daily

(2)Warfarin group
- 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)

- Warfarin K 1 mg tablets once daily (Dose adjusted with target PT-INR of 1.5-2.5)
Abe KohtaroNULLRecruiting>= 20age old<= 85age oldBoth74Phase 3Japan
2NCT04730037
(ClinicalTrials.gov)
April 9, 202125/1/2021Clinical 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: KABUKICTEPHDrug: Edoxaban;Drug: Warfarin Potassium;Drug: Warfarin Potassium placebo;Drug: Edoxaban placeboKyushu UniversityDaiichi Sankyo Co., Ltd.Recruiting20 Years85 YearsAll74Phase 3Japan
3JPRN-UMIN000018520
2016/01/0101/01/2016Clinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertension CTEPH (chronic thromboembolic pulmonary hypertension)Initiation of once-daily Edoxaban(60mg) during 6 months after 2 days discontinuation of warfarinDivision of Cardiovascular Medicine, Department of Internal Medicine Kobe University Graduate School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Phase 4Japan