治験一覧
8,963 件中 5721〜5740 件を表示
脊髄小脳変性症（SCD）患者を対象としたKPS-0373の延長試験
The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients.
第一選択薬または第二選択薬としてレナリドミドをベースとした治療後の再発または難治性多発性骨髄腫患者における、低用量デキサメタゾンとポマリドミドの併用、または低用量デキサメタゾンおよびダラツムマブとポマリドミドの併用
This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy. This trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of \> 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide. This trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of \> 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of \>60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.
日本人健康被験者を対象とした、BI 655075（イダルシズマブ）単独投与またはダビガトランエテキシラートとの併用投与における安全性、薬物動態および薬力学を評価する研究
The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI 655075 following intravenous administration of single rising doses of BI 655075 when administered alone and after administration of dabigatran.
Micra経カテーテルペースメーカーに関する研究
The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.
ボグリボース錠0.2mg / OD錠0.2mg 特別医薬品使用監視「耐糖能異常患者における長期使用」
The purpose of this study is to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting.
健康な日本人男性および白人男性を対象とした経口セマグルチドの薬物動態、薬力学、安全性および忍容性を評価するための臨床試験
This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), safety and tolerability of oral semaglutide in healthy male Japanese and Caucasian subjects.
中等度から重度の関節リウマチ患者を対象とした第IIB相用量設定試験
The primary purpose of this study is to identify an appropriate dose of study medication.
APOLLO：トランスサイレチン（TTR）介在性アミロイドーシスの治療薬パチシラン（ALN-TTR02）の研究
The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.
進行性固形腫瘍を有する日本人成人患者における経口LCL161の安全性および忍容性
This study will evaluate safety and tolerability to estimate the maximum tolerated dose and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors.
上皮成長因子受容体（EGFR）変異非小細胞肺癌（NSCLC）患者におけるキセンツズマブ（BI 836845）とアファチニブの併用療法
Part A: To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of Xentuzumab (BI 836845) in combination with afatinib in patients with non-small cell lung cancer with progression following prior treatment (EGFR TKI or platinum-based chemotherapy). Part B: To evaluate the early anti-tumour activity of Xentuzumab (BI 836845) in combination with afatinib in patients with EGFR mutant non-small cell lung cancer with progression following prior irreversible EGFR TKIs. Part A and B: To evaluate the safety and pharmacokinetics of BI 836845 in combination with afatinib in patients with non-small cell lung cancer
選択的手術を受ける慢性肝疾患患者における血小板減少症の治療
This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).
ステージIVまたは再発PD-L1陽性非小細胞肺癌に対する一次治療としてのニボルマブと治験責任医師選択化学療法を比較する非盲検無作為化第3相試験（CheckMate 026）
The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy
好酸球性多発血管炎性肉芽腫症の治療におけるメポリズマブの効果を調査する研究
The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram \[mg\] administered subcutaneously \[SC\] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.
成人喘息の診断におけるメタコリン塩化物負荷試験の有効性と安全性を評価する研究
The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma
小児統合失調症患者におけるアリピプラゾールの短期治療研究
The objective of this study is to investigate the efficacy and safety of three different doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a period of 6 weeks in pediatric patients (aged 13-17 years) with schizophrenia
メチシリン耐性黄色ブドウ球菌（MRSA）感染症の日本人患者におけるBAY1192631の安全性および有効性
The aim of this study is to see the efficacy and safety of BAY1192631 in Japanese patients with methicillin-resistant staphylococcus aureus (MRSA) (skin and soft tissue infections (SSTI) and SSTI-related bacteremia).
AGN-229666 季節性または通年性アレルギー性結膜炎の治療用点眼液
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.
大腸洗浄におけるFE 999169とNiflecの比較に関する第III相試験
To demonstrate non inferiority of a) "FE 999169 Split Dosing Schedule" (one dose on the day before and the second dose on the day of colonoscopy) and b) "FE 999169 Day Before Dosing Schedule" (two doses on the day before colonoscopy) to " Niflec On the Day Dosing Schedule" in subjects requiring colonoscopy.
血液透析を受けている慢性腎臓病（CKD）患者におけるエポエチンアルファ／ベータ療法とBAY85-3934療法を比較した、慢性腎臓病に伴う貧血の維持療法に関する長期延長試験
Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg once daily.
日本人患者におけるアルコン® Ex-PRESS®緑内障濾過装置
The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS® Glaucoma Filtration Device (Ex-PRESS) in Japanese subjects with normal tension glaucoma.