治験一覧
8,963 件中 3641〜3660 件を表示
薬剤抵抗性てんかんを有する成人被験者における焦点発作の治療薬としてのパドセボニルの有効性および安全性を検証する研究
The purpose of the study is to evaluate the efficacy, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.
中等度から重度のアトピー性皮膚炎を有する成人患者に投与されたREGN3500の有効性、安全性、および薬物動態プロファイル
The primary objective of the study is to assess the efficacy of REGN3500 monotherapy in Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD. Secondary objectives are to: * Assess the safety and tolerability of subcutaneous (SC) doses of REGN3500 monotherapy in adult patients with moderate-to-severe AD * Assess the Pharmacokinetics (PK) of REGN3500 in adult patients with moderate-to-severe AD * Assess the immunogenicity of REGN3500 in adult patients with moderate-to-severe AD
日本人健常者を対象としたベンザチンベンジルペニシリン筋肉内注射に関する研究
This will be an open label study to investigate the pharmacokinetics (PK) and safety of a single intramuscular injection of penicillin G benzathine in Japanese healthy subjects.
非介入型多施設共同Bicontact® E PMCF研究
Prospective observational (non-interventional) cohort study, multi-centric in 5 study Centers in Japan to collect short term clinical and radiological results of the cementless Bicontact® E stem in a standard patient population used in routine clinical practice
シスプラチン非適応尿路上皮癌におけるエパカドスタットまたはプラセボとの併用によるペムブロリズマブ（KEYNOTE-672/ECHO-307）
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.
双極性障害I型うつ病に伴う大うつ病エピソードを発症した患者に対する治験薬の有効性を検証する臨床試験
A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression
進行固形腫瘍患者を対象としたMK-4830の単剤療法およびペムブロリズマブ（MK-3475）との併用療法の試験（MK-4830-001）
This study consists of several parts: dose escalation, dose expansion, dose expansion in Chinese participants residing in China, and coformulation. Dose escalation is to evaluate the safety, tolerability, and preliminary efficacy of MK-4830 monotherapy administration (Arms A and B) and in combination with pembrolizumab (Arm C). Dose expansion is to evaluate the objective response rate (ORR) of MK-4830 in combination with pembrolizumab (Arms A-F); evaluate the safety and tolerability of MK-4830 administered in combination with pembrolizumab, carboplatin, and pemetrexed (Arm G) and of MK-4830 administered in combination with pembrolizumab and lenvatinib (Arm H); evaluate the safety, tolerability and ORR of MK-4830 in combination with pembrolizumab plus chemotherapy (Arms I-L); and evaluate the safety and tolerability of MK-4830 in combination with pembrolizumab in Chinese participants from China (Arm M). The coformulation part (Arm N) evaluates the safety and tolerability of MK-4830A (coformulation of MK-4830 800 mg + pembrolizumab 200 mg). There is no formal hypothesis testing in this study.
トラスツズマブおよびタキサンによる治療歴を有するヒト上皮成長因子受容体2（HER2）陽性、切除不能および/または転移性乳がんに対するDS-8201aとT-DM1の比較 [DESTINY-Breast03]
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
進行性B細胞非ホジキンリンパ腫の成人患者を対象としたJCAR017の有効性および安全性を評価する臨床試験
The purpose of this study is to evaluate the efficacy and safety of JCAR017 in participants with aggressive B-cell non-Hodgkin lymphoma (B-NHL)
FLT3変異AMLと新規診断された小児患者における、ミドスタウリンと化学療法の併用による安全性、有効性、薬物動態を評価する国際共同研究
This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia. The study has two parts: Part 1 to define the Recommended Phase 2 Dose, and Part 2 to evaluate safety and tolerability and efficacy of midostaurin. Both parts will consist of 2 induction blocks, 3 consolidation blocks, 12 cycles of post-consolidation consisting of continuous therapy with midostaurin, and a follow-up phase.
ST上昇型急性心筋梗塞の治療における2種類の異なるエベロリムス溶出ステントを用いた場合の早期および後期の血管反応のメカニズムの比較：生分解性ポリマーステントと耐久性ポリマーステント間のランダム化比較試験（MECHANISM-AMI-RCT）
To place two different everolimus-eluting stents (EES), a bioabsorbable polymer EES (Synergy®) and a permanent-type polymer EES (Xience®), randomly to the ST-elevation acute myocardial infarction (AMI) and to observe and compare the early and chronic vascular responses using the frequency domain optical coherence tomography (FD-OCT). The primary endpoint is the 2-week strut coverage rate by FD-OCT.
ドライビングシミュレータを用いた健常者運転能力評価法の開発 #3
The purpose of this study is to collect alcohol calibration data for the driving simulator.
炎症性腎疾患患者におけるLNP023の安全性および有効性に関する研究
Efficacy and safety of LNP023 in IgAN patients
子宮筋腫および過多月経を有する日本人被験者におけるビラプリサンの安全性および有効性を評価するための研究
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
TAK-438ASA錠の生物学的同等性（BE）および食事の影響を評価するための研究
The purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 milligram (mg) and aspirin enteric-coated tablet 100 mg in Japanese healthy adult men (Study 1), and to evaluate the effects of food on the pharmacokinetics of TAK-438ASA tablet in Japanese healthy adult men (Study 2).
進行性または手術不能な胃がん患者を対象としたBGB-290またはプラセボの投与に関する研究
This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.
重症血友病AおよびB患者（以前に因子製剤またはバイパス製剤による予防療法を受けていた患者）におけるフィツシランの研究
Primary Objective: To characterize the frequency of bleeding episodes (BE) while receiving fitusiran treatment, relative to the frequency of bleeding episodes while receiving factor concentrate or bypassing agent (BPA) prophylaxis. Secondary Objectives: * To characterize the following while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis: * the frequency of spontaneous bleeding episodes * the frequency of joint bleeding episodes * health related quality of life (HRQOL) in participants greater than or equal to (\>=) 17 years of age * To characterize the frequency of bleeding episodes during the onset and treatment periods in participants receiving fitusiran. * To characterize the safety and tolerability of fitusiran. * To characterize the annualized weight-adjusted consumption of factor/BPA while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis.
切除不能肝細胞癌（HCC）患者を対象としたティスレリズマブとソラフェニブの比較試験
This Phase 3 study was a global, multicenter trial that randomly assigned participants to either tislelizumab or sorafenib as a first-line treatment for adults with advanced liver cancer (hepatocellular carcinoma) that could not be surgically removed. Before enrolling Japanese participants in the main Phase 3 study, a preliminary assessment of safety and tolerability (the Safety Run-In Sub-study) was conducted in Japan.
巨細胞性動脈炎患者におけるウパダシチニブの安全性と有効性を評価する試験
This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of Period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1. Safety and efficacy data through 06 February 2024 are included in the interim analysis, which was conducted after all participants completed the Week 52 visit or discontinued from the study.
中等度から重度のクローン病患者を対象とした、導入療法としてのオンタマリマブの有効性および安全性に関する研究（CARMEN CD 306）
The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.