治験一覧
8,963 件中 5861〜5880 件を表示
健康な男性被験者へのASP2408皮下投与後の安全性評価に関する研究
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The pharmacodynamics of ASP2408 is also being evaluated.
日本人健康男性ボランティアにおけるテルミサルタン、アムロジピン、およびヒドロクロロチアジド（HCTZ）の各種製剤の薬物動態
To assess drug drug interaction through pharmacokinetics investigation at steady state of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations in healthy Japanese male subjects
DMDにおけるNS-065/NCNP-01の探索的研究
This study is designed to assess the safety, tolerability, efficacy and pharmacokinetics (PK) of NS-065/NCNP-01 in subjects diagnosed with Duchenne muscular dystrophy (DMD).
ラメルテオン8mg錠特定薬物使用調査：＜入眠困難を伴う不眠症に関する長期調査＞－前回の薬物使用調査からの移行調査－
The purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.
治療抵抗性うつ病における鼻腔内エスケタミンの安全性と有効性を評価する研究
The purpose of this study is to assess the efficacy and dose response of intranasal esketamine (Panel A: 28 mg, 56 mg, and 84 mg and Panel B: 14 mg and 56 mg) compared with placebo in improving depressive symptoms in participants with treatment-resistant depression (TRD).
進行固形腫瘍患者におけるTAS-120の研究
This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts: 1. Dose escalation portion to determine the -Maximum Tolerated Dose and/ or Recommended Phase 2 Dose of futibatinib. 2. Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary central nervous system tumors, urothelial carcinoma, breast cancer, gastric cancer. 3. Phase 2 study portion to confirm objective response rate of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).
抗リン脂質症候群の非診断基準症状の治療薬ALXN1007の第IIa相臨床試験
The primary purpose of this study was to evaluate the safety and tolerability of intravenous (IV) ALXN1007 in persistently antiphospholipid (aPL)-positive patients with at least 1 of the following non-criteria manifestations of APS: aPL-nephropathy, skin ulcers and/or thrombocytopenia.
MT-2412の日本人2型糖尿病患者における長期安全性試験
The purpose of this study is to evaluate the safety and efficacy of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.
アジア人成人喫煙者における曝露バイオマーカーおよび潜在的有害性バイオマーカーの測定
The purpose of this study is to determine biomarkers of exposure to Harmful and Potentially Harmful Constituents (HPHCs) in Cigarette Smoke and cardiovascular-related biomarkers in smokers and non smokers.
化学療法未治療の転移性去勢抵抗性前立腺癌（mCRPC）患者を対象とした、アパルタミド（JNJ-56021927）とアビラテロン酢酸塩およびプレドニゾンの併用と、アビラテロン酢酸塩およびプレドニゾン単独との比較による有効性および安全性試験
The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy \[treatment of cancer using drugs\]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland \[gland that makes fluid that aids movement of sperm\]).
HLA-A*24またはA*02陽性の進行性固形腫瘍を治療するためのエピトープペプチドの安全性および有効性に関する研究
In this study, the investigators examine using a combination of two types of HLA-A\*2402 (or HLA-A\*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor patients who are refractory to standard therapy.
2型糖尿病患者におけるチカグレロルとプラセボの心血管系への影響を比較した研究
The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.
中等度から重度のアトピー性皮膚炎を有する成人患者を対象とした、デュピルマブ（REGN668/SAR231893）の有効性および長期安全性を評価する研究
The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.
急性心筋梗塞の治療におけるエベロリムス溶出コバルトクロムステントに対する早期および後期血管反応と血小板凝集試験の多施設比較 ST上昇型急性心筋梗塞の治療
To treat patients with acute myocardial infarction, primary percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 2 weeks or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.
喘息患者におけるデュピルマブの長期安全性評価（LIBERTY ASTHMA TRAVERSE）
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691). Secondary Objectives: To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study. To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to: * Systemic exposure * Anti-drug antibodies * Biomarkers
十分にコントロールされていない重症喘息の成人患者におけるMEDI9929（AMG 157）の有効性および安全性を評価する研究
The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929 (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.
再発性／再発性または難治性骨髄異形成症候群（MDS）患者におけるSyB L-1101の長期安全性試験 - 延長試験
This is an extension study study to investigate long term safety of SyB L-1101 when administered intravenously every 4 weeks to the patients who have completed 8 cycles in the study 2011005 whose purpose is to investigate tolerability of SyB L-1101 when administered intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome. Antitumor effects will also be investigated in this study.
ヘテロ接合型家族性高コレステロール血症患者または脂質調節療法を受けている高コレステロール血症の心血管リスクの高い患者におけるアリロクマブの有効性および安全性評価（ODYSSEY JAPAN）
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with placebo after 24 weeks of treatment in heterozygous familial hypercholesterolemia (HeFH) or high cardiovascular risk participants with hypercholesterolemia. Secondary Objectives: * To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment. * To evaluate the effect of alirocumab on other lipid parameters. * To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after 52 weeks of treatment. * To evaluate the safety and tolerability of alirocumab. * To evaluate the development of anti-alirocumab antibodies. * To evaluate the pharmacokinetics of alirocumab.
心血管疾患リスクの高い被験者におけるPCSK9結合抗体の認知機能への影響の評価
This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.
再発性または難治性多発性骨髄腫におけるダラツムマブ、レナリドミド、デキサメタゾンとレナリドミドおよびデキサメタゾンの併用療法の比較試験
The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.