治験一覧
8,963 件中 4441〜4460 件を表示
TRK-700とジゴキシンおよびミダゾラムとの薬物相互作用に関する研究
This study comprises 2 cohorts, and in each cohort, the study will be conducted as an open-label add-on study. The purpose of the study is to investigate the pharmacokinetics of each substrate in concomitant administration of a single dose of the P-glycoprotein substrate digoxin (Cohort A) or the CYP3A4 substrate midazolam (Cohort B) during repeated administration of TRK-700 in healthy adult males.
発作性片頭痛の予防治療におけるTEV-48125の皮下投与の有効性と安全性
To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 (monthly TEV-48125 225 mg and TEV-48125 675 mg once over a period of 3 months) compared with placebo for preventive treatment in Episodic Migraine patients
ダクラタスビル（DCV）3剤併用療法を受けた日本人患者における肝毒性および全副作用（ADR）の実臨床発生率
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
ペムブロリズマブと化学療法を併用した食道癌の一次治療と化学療法単独治療を比較する試験（MK-3475-590/KEYNOTE-590）
The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin and 5-FU as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma. The overall primary efficacy hypotheses are as follows: 1. In participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive (defined as combined positive score \[CPS\] ≥10), ESCC participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, overall survival (OS) is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy. 2. In participants with ESCC, participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.
PPI抵抗性GERD患者におけるC13-CAC呼気検査の臨床試験
To investigate the safety of C13-CAC and the relationship among C13-CAC breath test, gastric pH, and the improvement of symptoms by switching PPI in PPI resistant GERD patients
健康な成人男性被験者を対象とした、2種類の製剤と2種類の投与レジメンを用いたOPC-41061口腔内崩壊錠（OD錠）の研究
To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15 and 30 mg in healthy adult male subjects.
持続性高コレステロール血症患者におけるエビナクマブ（REGN1500）の研究
The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD.
潰瘍性大腸炎（UC）患者におけるウパダシチニブ（ABT-494）の長期安全性および有効性を評価する試験
This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.
駆出率低下を伴う慢性心不全患者におけるEMPアグリフロジンアウトカム試験（EMPEROR-Reduced）
The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.
膀胱癌の既往歴を有する患者の経過観察のための新規マルチプレックスELISAアッセイ
Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We propose to improve the non-invasive detection of recurrent BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples.
健康な乳児を対象としたBK1310の第3相試験
The purpose of this study is to: * (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310. * (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.
家庭血圧測定によるアジアにおける高血圧の種類別分布を明らかにするための研究（アジアBP@Home）
Blood pressure variability (BPV) is being increasingly recognized as an important influence on hypertension outcomes as well as a risk factor for other cardiovascular (CV) events. However, in Asia there is a current lack of awareness of BPV and its significance on patient outcomes. Furthermore, there is ongoing debate on the role of home blood pressure (HBP) monitoring in managing hypertension patients and uncertainty on how best to integrate it into clinical practice. Therefore, we conduct Asia BP@Home study to assess HBP control status in each Asian country and develop an Asian consensus and Asia-specific treatment for hypertension.
再発性および/または難治性多発性骨髄腫患者に対するカルフィルゾミブ、ダラツムマブおよびデキサメタゾンの研究。
Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone (Kd) in terms of progression free survival (PFS) in participants with multiple myeloma who have relapsed after 1 to 3 prior therapies.
アトピー性皮膚炎におけるバリシチニブ（LY3009104）の長期投与に関する研究
The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis. Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.
高リスク骨髄異形成症候群（HR MDS）、慢性骨髄単球性白血病（CMML）、または低芽球比率急性骨髄性白血病（AML）の参加者に対する第一選択治療としてのペボネジスタットとアザシチジンの併用とアザシチジン単独との比較
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).
中等度から重度の活動性クローン病患者におけるリサンキズマブの有効性および安全性に関する研究
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
慢性C型肝炎ウイルス感染症および非代償性肝硬変を有する成人におけるソホスブビル/ベルパタスビル±リバビリンの12週間投与の有効性および安全性
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis.
メドトロニック・ハーモニー™経カテーテル肺動脈弁の臨床試験
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.
切除不能膵臓がん患者を対象としたTBI-1401(HF10)と化学療法の併用療法に関する第I相試験。
The purpose of this study is to determine the recommended dose of TBI-1401(HF10) treatment in combination with chemotherapy (Gemcitabine + Nab-paclitaxel or TS-1) in patients with stage III or IV unresectable pancreatic cancer.
体液過剰を伴う小児うっ血性心不全（CHF）患者におけるトルバプタンの有効性、安全性、薬物動態および薬力学に関する研究
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload