治験一覧
8,963 件中 4661〜4680 件を表示
びらん性食道炎患者におけるボノプラザンの長期安全性評価に関する研究
The purpose of this study is exploratorily evaluate the effect on gastric mucosal tissue and the safety of long-term administration (260 weeks: 5 years) of vonoprazan 10 mg or 20 mg in patients receiving maintenance treatment after healed erosive esophagitis (EE), and the curative effect of vonoprazan 20 mg versus lansoprazole in patients with EE.
中等度の腎機能障害を有する2型糖尿病患者におけるベキサグリフロジンの安全性および有効性
This was a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of oral administration of bexagliflozin at 20 mg versus placebo in subjects with T2DM, moderate renal impairment and inadequate glycemic control.
EXIST-3試験[CRAD001M2304]を完了し、継続治療の恩恵を受けているTSCおよび難治性発作患者におけるエベロリムスの長期安全性を収集および評価するためのロールオーバー試験
この研究の目的は、ノバルティスがスポンサーとなっているEXIST-3試験で現在エベロリムス治療を受けており、EXIST-3の完了時に治験責任医師によって治療継続の利益があると判断されたTSCおよび難治性発作患者の長期安全性を評価することです。
腫瘍誘発性骨軟化症または表皮母斑症候群の被験者におけるKRN23の研究
Before switching to the post-marketing study: To evaluate the efficacy and safety of KRN23 after its 144-week once every 4 weeks (Q4W) repeated SC administration to Japanese and Korean patients with TIO or ENS by a multicenter, open-label, intraindividual dose adjustment study. After switching to the post-marketing study: To evaluate the safety and efficacy of KRN23, which is switched from the investigational product to the post-marketing investigational product, at the approved dose and dosing regimen in subjects who continue treatment after the marketing approval of KRN23 in Japan.
PARTNER 3試験：大動脈弁狭窄症の低リスク患者におけるSAPIEN 3経カテーテル心臓弁の安全性と有効性
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
新しい国際CTEPHデータベース
The New International CTEPH Database is a prospective, observational multi-center disease registry run by the International CTEPH Association (ICA), which will collect data in chronic thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will run for approximately 5 years. Its objective is to provide an overview on epidemiology of CTEPH, mode of diagnosis and treatment approaches worldwide as well as determinants of long-term outcomes as measured by New York Heart Association (NYHA) functional class and survival. The data collected will improve the knowledge and understanding of this condition, support the further development of diagnosis and treatment guidelines for patients with CTEPH, and contribute to improving patient care in the long-term.
難治性および再発・難治性多発性骨髄腫の治療を目的とした、ポマリドミドと低用量デキサメタゾンをエロツズマブ併用または非併用で投与する治験免疫療法試験（ELOQUENT-3）
The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.
GLP-1受容体作動薬への追加投与としてのエンパグリフロジンの長期安全性および有効性
This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control
静脈血栓塞栓症患者のコンピュータ化レジストリ（RIETE）
The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive data registry of consecutive patients with venous thromboembolism. The main objective is to provide information on the Internet to help physicians to improve their knowledge on the natural history of thromboembolic disease, particularly in those subgroups of patients who are usually not recruited in randomized clinical trials (pregnant women, elderly patients, disseminated cancer, severe renal insufficiency, patients with contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of decreasing mortality, frequency of thromboembolic recurrences as well as bleeding complications and arterial events. As an additional objective RIETE is also aimed to create predictive scores that help physicians to better identify patients with high risk of presenting some of these complications. The primary parameters recorded by the registry comprise details of each patient's clinical status, including any coexisting or underlying conditions, and the type, dose, duration and outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.
同種幹細胞移植後のステロイド抵抗性急性移植片対宿主病患者におけるルキソリチニブと最良の治療法との安全性および有効性の比較
Assess the efficacy and safety of ruxolitinib compared to Best Available Therapy (BAT) in patients with corticosteroid-refractory acute graft vs. host disease (aGvHD) after allogeneic stem cell transplantation.
NextStep：軽度から中等度のアルツハイマー病患者におけるリバスチグミンパッチの安全性、有効性、忍容性を評価する研究。
To evaluate the efficacy of rivastigmine patch with 1-step titration on cognitive function measured as change from baseline to week 24 in the total score of Mini-Mental State Examination (MMSE) in mild to moderate Alzheimer's disease (AD) patients who failed to benefit from other cholinesterase inhibitors (ChEIs).
補体阻害剤治療未経験の発作性夜間ヘモグロビン尿症（PNH）成人患者を対象としたALXN1210（ラブリズマブ）とエクリズマブの比較試験
The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).
アルファ1アンチトリプシン欠乏症患者におけるアルファ1 MP（アルファ1プロテイナーゼ阻害剤（ヒト）、改変プロセス）の安全性および薬物動態
This study is a multicenter, open-label trial to evaluate the safety and pharmacokinetics of weekly intravenous infusions of 60 mg/kg of Alpha-1 MP (alpha1-proteinase inhibitor (human), modified process) for 8 weeks.
再発性および／または難治性多発性骨髄腫を有する日本人成人患者を対象としたイキサゾミブ＋レナリドミド＋デキサメタゾン併用療法の研究
The purpose of this study is to evaluate the efficacy and safety of ixazomib plus lenalidomide and dexamethasone in Japanese participants with relapsed and/or refractory multiple myeloma (RRMM).
血友病A患者におけるコバルトリの薬物使用調査
The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.
呼吸器合胞体ウイルス感染症で入院した成人患者における経口投与ルミシタビン療法の抗ウイルス活性、臨床転帰、安全性、忍容性、および薬物動態を評価する研究
The purpose of this study is to characterize the Pharmacokinetic and to confirm the popPK model derived from healthy volunteers in hospitalized adults who are infected with respiratory syncytial virus (RSV) and to determine in adults who are hospitalized with respiratory syncytial virus (RSV) infection the dose response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.
2型糖尿病患者におけるインスリンとの併用によるカナグリフロジン（TA-7284）の長期安全性試験
This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)
慢性閉塞性肺疾患（COPD）患者を対象とした、フルチカゾンフランカルボン酸エステル（FF）／ウメクリジニウム臭化物（UMEC）／ビランテロール（VI）併用療法とFF／VI＋UMEC併用療法の比較研究
This multicenter study will be conducted to compare the effect of FF/UMEC/VI with FF/VI plus UMEC on lung function after 24 weeks of treatment. This is a phase IIIB, 24-week, randomized, double-blind, parallel group multicenter study. This study will test the hypothesis that the difference in trough forced expiratory volume in one second (FEV1) between treatment groups is less than or equal to a pre-specified non-inferiority margin. Alternatively, this study will also test the hypothesis that the difference between treatment groups is greater than the margin. The triple therapy of FF/UMEC/VI in a single inhaler is being developed with the aim of providing a new treatment option for the management of advanced Global Initiative for Chronic Obstructive Lung Disease (GOLD) Group D COPD which will reduce the exacerbation frequency, allow for a reduced burden of polypharmacy, convenience, and improve lung function, health related quality of life (HRQoL) and symptom control over established dual/monotherapies. This study has a 2 week run in period where subjects will continue to have their existing COPD medications. At randomization, subjects will discontinue all existing COPD medications and will be assigned to treatment of FF/UMEC/VI, 100 microgram (mcg)/62.5 mcg/25 mcg and placebo or FF/VI, 100 mcg/25 mcg and UMEC, 62.5 mcg in a 1:1 ratio for 24 weeks. Subjects will have clinical visits at Pre-Screening (Visit 0), Screening (Visit 1), Randomization (Week 0, Visit 2), Week 4 (Visit 3), Week 12 (Visit 4) and Week 24 (Visit 5). A follow-up visit will be conducted at 1 week after the end of treatment period or after early withdrawal visit. Approximately, 1020 subjects will be enrolled in this study. There will be two pharmacokinetic (PK) groups (subset A and subset B). Approximately 120 subjects will be assigned to subset A and approximately 60 subjects will be assigned to subset B. The total duration of subject participation will be approximately 27 weeks, consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up period.
日本人2型糖尿病患者を対象とした、インスリンデグルデク/リラグルチド、インスリンデグルデク、およびリラグルチドの有効性および安全性を比較する臨床試験。
This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with type 2 diabetes mellitus.
FID 120947Aの安全性および有効性の臨床評価
The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.