治験一覧
8,963 件中 4061〜4080 件を表示
健康な乳児におけるBK1310筋肉内注射の安全性と有効性
The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.
心房細動（AF）のスクリーニング - AF検出率向上のための潜在的患者
To assess the prevalence of all (prevalent and paroxysmal) undiagnosed atrial fibrillation (AF) in a Japanese population with a moderate-to-high risk of stroke
健康な日本人被験者におけるJNJ-64179375の安全性、忍容性、薬物動態、免疫原性および薬力学を評価するための研究
The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.
ファロー四徴症を生涯にわたって治療する
The aim is to conduct a prospective multi-centre international inception cohort study with an enrollment goal of 3,000 TOF patients and 2 year follow-up post-repair. The proposed sample size and methodology will result in statistically powerful results to allow for evidence-based change to current TOF surgical practices.
自閉症患者におけるアリピプラゾールの市販後調査
The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in patients with autism in the real world clinical setting in Japan.
切除不能なステージIIIB～IVの悪性黒色腫を有する日本人患者におけるT-VECの安全性／有効性を評価する研究
There are 2 fold of purposes for this study. 1 is to evaluate safety and tolerability and the other is to study the anti-tumor effects of talimogene laherparepvec in Japanese participants with unresectable stage IIIB-IV malignant melanoma.
ウルソデオキシコール酸に不十分な反応を示す原発性胆汁性胆管炎の日本人患者におけるE6011の有効性に関する研究
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.
非透析依存性慢性腎臓病（NDD-CKD）に伴う貧血を有する日本人被験者におけるバダドゥスタットの用量探索試験
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD).
ボクロスポリン投与による活動性ループスにおけるアウリニア腎反応
The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
睡眠覚醒リズム障害および軽度から中等度のアルツハイマー病認知症に対するレンボレキサントの研究
This study will be conducted to determine the dose response of lemborexant (LEM) on the change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters, and circadian-rhythm related parameters. Following the eligibility screening period, eligible participants will be assigned at random to 1 of 4 doses of LEM or to placebo for 4 weeks. After a 2-week follow-up period, eligible participants may enter an open-label extension period for up to 30 months or until the program discontinuation.
高レベルのデルタ様タンパク質3（DLL3）を有する進行性または転移性小細胞肺癌患者で、初回プラチナ製剤ベースの化学療法中または後に初めて病勢進行が認められた患者を対象に、ロバルピツズマブ・テシリンとトポテカンを比較する研究（TAHOE）
The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.
妊娠末期の女性における膣挿入剤の有効性と安全性を調査する非盲検試験
To demonstrate the efficacy of controlled-release dinoprostone vaginal insert (DVI) for cervical ripening success (either Bishop Score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration.
健康な成人および高齢のボランティア、ならびにナルコレプシー患者を対象としたTAK-925の第1相臨床試験
The purpose of this study is to investigate safety, tolerability, and pharmacokinetics of TAK-925 when a single dose of TAK-925 is administered to healthy adult participants, healthy elderly participants and patients with type 1 narcolepsy.
ベンズブロマロン対照二重盲検比較試験：痛風の有無にかかわらず高尿酸血症患者におけるFYU-981の有効性
FYU-981 or Benzbromarone are administrated to hyperuricemia patients with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.
肝細胞癌患者を対象としたレンバチニブとペムブロリズマブの併用療法に関する臨床試験
This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).
日本における壊疽性膿皮症の活動性潰瘍に対するアダリムマブの有効性および安全性を評価する研究
This study is designed to investigate the efficacy, safety and pharmacokinetics of adalimumab in subjects in Japan with active ulcer(s) due to Pyoderma Gangrenosum (PG).
生体吸収性ポリマーコーティングステント留置後の高出血リスク患者に対する、短縮DAPT療法と長期DAPT療法の比較管理
The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube). This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.
ワルファリンとダビガトランの有効性と安全性の比較
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.
持続性心房細動に対する左房後壁アブレーションの有無による肺静脈アブレーションの比較（PIVoTAL）
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent or long-standing persistent AF one year after an ablation procedure in comparison to a PVI ablation procedure, alone. The investigator hypothesizes that the combination of PVI plus PLAW isolation will result in a reduction in recurrence of atrial arrhythmias at one year after ablation.
骨粗鬆症に対するゾレドロン酸の有効性
There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.