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 : 157 / 薬物数 : 107 - (DrugBank : 22) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 54
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2071200098 | 09/04/2021 | 08/02/2021 | Phase III Investigator-Initiated Trial to Investigate Safety and Efficacy of Edoxaban in Patients with Chronic Thromboembolic Pulmonary Hypertension | An 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 Kohtaro | NULL | Not Recruiting | >= 20age old | <= 85age old | Both | 74 | Phase 3 | Japan |
| 2 | NCT04730037 (ClinicalTrials.gov) | April 9, 2021 | 25/1/2021 | 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 | CTEPH | Drug: Edoxaban;Drug: Warfarin Potassium;Drug: Warfarin Potassium placebo;Drug: Edoxaban placebo | Kyushu University | Daiichi Sankyo Co., Ltd. | Active, not recruiting | 20 Years | 85 Years | All | 74 | Phase 3 | Japan |
| 3 | JPRN-UMIN000018520 | 2016/01/01 | 01/01/2016 | Clinical 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 - 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 warfarin | Division of Cardiovascular Medicine, Department of Internal Medicine Kobe University Graduate School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 60 | Phase 4 | Japan |