治験一覧
8,963 件中 4221〜4240 件を表示
うっ血性心不全患者におけるトルバプタン15mg錠に相当するOPC-61815注射剤の投与量を調査する臨床薬理試験
The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.
骨髄線維症患者におけるナビトクラックス単独またはルキソリチニブとの併用の忍容性と有効性を評価する研究
This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.
ACS治療のためのIDEの最適化
Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm
移植不適応の新規診断多発性骨髄腫成人患者における、イサツキシマブとボルテゾミブ、レナリドミド、デキサメタゾンの併用療法の臨床的有用性を調査する研究
Primary Objective: -To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in participants with newly diagnosed multiple myeloma (NDMM) not eligible for transplant. Secondary Objectives: * To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms: * Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria. * Minimal residual disease (MRD) negativity rate in participants with CR. * Very good partial response or better rate, as defined by the IMWG criteria. * Overall survival (OS). * To evaluate the overall response rate (ORR) as per IMWG criteria. * To evaluate the time to progression (TTP) overall and by MRD status. * To evaluate PFS by MRD status. * To evaluate the duration of response (DOR) overall and by MRD status. * To evaluate time to first response (TT1R). * To evaluate time to best response (TTBR). * To evaluate progression-free survival on next line of therapy (PFS2). * To evaluate the sustained MRD negativity \>12 months rate. * To evaluate safety. * To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only). * To evaluate the immunogenicity of isatuximab in participants receiving isatuximab (IVRd and crossover arms). * To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.
疾患初期または疾患後期の治療抵抗性統合失調症患者におけるLu AF35700の有効性
This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia (TRS)
健康な日本人被験者を対象としたM201-Aのヒト初回投与量漸増試験
This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects.
日本における進行性／転移性非小細胞肺癌（NSCLC）患者に対するニボルマブの有効性および安全性に関する後ろ向き研究
A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in Japan
日本発の頭蓋内血管閉塞に対する血栓除去・血行再建術（TRON1-Japan）
To evaluate the efficacy and safety of catheter-based thrombectomy for reperfusion by removing a thrombus in a cerebral blood vessel in patients with acute cerebral infarction (within 8 hours after onset), in whom intravenous administration of tissue plasminogen activator (t-PA) is not indicated or reperfusion cannot be achieved by intravenous t-PA administration.
日本人喘息患者におけるQVM149の長期安全性試験
The purpose of this study is to provide long term safety data of QVM149 in Japanese patients with asthma for the registration of QVM149 in Japan.
進行性再発/難治性固形腫瘍患者を対象とした、LY3321367単独投与またはLY3300054との併用投与に関する研究
The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.
エリブリンメシル酸塩＋ペルツズマブ＋トラスツズマブとパクリタキセルまたはドセタキセル＋ペルツズマブ＋トラスツズマブを比較する研究
To verify that combination therapy with trastuzumab + pertuzumab + eribulin brings similar PFS and better QOL compared to trastuzumab + pertuzumab + taxane in advanced/recurrent HER2-positive breast cancer patients who have no medical history of chemotherapy except ado-trastuzumab emtansine
プラダクサ錠プロトンポンプ阻害薬（PPI）の生物学的利用能（BA）に関する研究（日本）
The primary objective of this trial is to investigate the relative Bioavailability (BA) of tablet formulation of Dabigatran etexilate (DE) with and without co-administration of rabeprazole in healthy male subjects. The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments.
16歳以上の部分発作患者（二次性全般化発作の有無を問わず）における補助療法としてブリバラセタム（BRV）を使用した場合の安全性と有効性を検証する研究
The purpose of the study is to evaluate the long-term safety and tolerability of Brivaracetam (BRV) in focal epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV over time.
前駆期から軽度アルツハイマー病（AD）患者におけるクレネズマブとプラセボの有効性および安全性を評価するための研究
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).
ヒト上皮成長因子受容体2（HER2）発現胃癌におけるDS-8201a [DESTINY-Gastric01]
The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens including fluoropyrimidine agent, platinum agent, and trastuzumab.
2種類以上のTKIによる治療を受けたCML-CP患者に対するABL001とボスチニブの有効性の比較試験
The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs. Patients intolerant to the most recent TKI therapy must have had BCR-ABL1 ratio \> 0.1% IS at screening and patients failing their most recent TKI therapy must have met the definition of treatment failure as per the 2013 European LeukemiaNet (ELN) recommendations. Patients with documented treatment failure as per 2013 ELN recommendations while on bosutinib treatment had the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.
日本における経口血糖降下薬で治療された2型糖尿病患者の臨床的特徴と診療パターン：MDV医療・健康データベースの分析
Appropriate use of oral antidiabetic drugs (OADs) including dose-reduction is important for patient's safety in T2DM patients with renal impairment (RI). However, there are insufficient data on dose adjustment in accordance with the prescription pattern and the risk of RI of OADs, in particular Dipeptidyl-peptidase-4 inhibitors, in clinical practice in Japan. Therefore, we will investigate OADs usage conditions and dose selection in T2DM patients with RI in clinical practice in Japan
アルポート症候群患者におけるバルドキソロンメチルの有効性と安全性を評価する第2/3相試験 - CARDINAL
This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.
鉄イソマルトシド（モノファー®）の安全性、薬物動態、および薬力学に関する用量漸増試験
The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.
日本で行われたMiStentとXienceの比較試験
To compare the MT005 (MiStent) with the XIENCE with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real world" patient population and to confirm that the domestic extrapolation of the DESSOLVE III study results is valid.