Edoxaban ( DrugBank: Edoxaban )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ2
88慢性血栓塞栓性肺高血圧症3

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1JPRN-UMIN000026819
2016/11/2101/04/2017A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients.A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients. - A RCT of anticoagulant agents for prevention of VTE after THA in elderly or underweight or moderate renal insufficient patients. osteoarthritis of the hip, osteonecrosis of the femoral head, femoral neck fracture, rheumatoid arthritis, rapidly destructive coxarthropathy, septic arthritis of the hipDose:
Edoxaban group; Edoxaban 15mg per day
Enoxaparin gropu; Enoxaparin 2000 IU per day
Intervention period:
for 10 days after the surgery
Department of Orthopaedic Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesNULLComplete: follow-up complete20years-oldNot applicableMale and Female80Not selectedJapan
2JPRN-UMIN000018101
2012/10/0126/06/2015Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective studyVenous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study - Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study Osteoarthritis, rheumatoid arthritis, osteonecrosisTo determine whether postoperative VTE is present and to evaluate the efficacy and safety of edoxaban for the prevention of patients undergoing TKA, OWHTO, or CWHTO, angiography of the pulmonary artery and deep veins of the lower limbs is performed in all patients on postoperative day 7.
Levels of coagulation and fibrinolysis markers are evaluated on the preoperative day and on postoperative days 1, 3, 7, and 14.
Yokohama City University School of MedicineNULLComplete: follow-up completeNot applicableNot applicableMale and Female100Not selectedJapan

88. 慢性血栓塞栓性肺高血圧症


臨床試験数 : 157 薬物数 : 107 - (DrugBank : 22) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 54
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
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 KohtaroNULLNot Recruiting>= 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.Active, not recruiting20 Years85 YearsAll74Phase 3Japan
3JPRN-UMIN000018520
2016/01/0101/01/2016Clinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertensionClinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertension - Clinical 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