治験一覧
8,963 件中 5661〜5680 件を表示
日本人てんかん女性におけるラモトリギン導入によるバルプロ酸の減量とその臨床評価 ― 単群、多施設共同、非盲検試験
The purpose of this study is to examine whether the VPA (Valproate) dose can be reduced by additional administration of LTG (Lamotrigine) in Japanese pre-menopausal female epilepsy patients aged 15 years or older, whose seizures are well controlled by VPA monotherapy.
国立脳血管疾患センター（NCVC）脳卒中登録
A single-center registry of patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the National Cerebral and Cardiovascular Center (NCVC) to determine change in underlying characteristics, stroke features and severity, process for diagnosis and acute treatment, and long-term outcomes of stroke/TIA patients over the years.
原発性高コレステロール血症の日本人被験者を対象とした、エバセトラピブ（LY2484595）とアトルバスタチンの併用療法に関する研究
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as evacetrapib when administered in combination with atorvastatin for 12 weeks in Japanese participants with primary hypercholesterolemia.
大うつ病性障害患者におけるASC-01の有効性および安全性を評価する
To evaluate the efficacy and the safety of ASC-01 (aripiprazole/sertraline combination) compared to sertraline monotherapy in patients with major depressive disorders who have responded incompletely to sertraline monotherapy.
尿失禁および腹圧性尿失禁の兆候を示す女性患者におけるプロピベリン塩酸塩の研究
This study is to evaluate the efficacy and safety that the occurrence of incontinence is significantly decrease using the propiverine hydrochloride for 200 female patients with mixed (stress and urge) urinary incontinence in one week during a twelve-week treatment period.
生殖細胞系列BRCA変異陽性高リスクHER2陰性原発性乳がん患者に対するオラパリブの術後補助療法
Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
頭頸部がん患者における化学放射線療法誘発性口腔粘膜炎の予防に有効な用量を決定するためのレバミピド液剤の第2相臨床試験
To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide.
大腸ポリープの完全切除：内視鏡的粘膜切除術と従来型ポリープ切除術の前向き無作為化比較試験
Recently, it was reported that the incomplete resection rate of neoplastic large polyps after conventional polypectomy was markedly high in clinical practice. The incomplete resection rate of neoplastic large polyps after endoscopic mucosal resection (EMR) is not known. The aim of this study is to compare the incomplete resection rate of neoplastic large polyps after EMR or conventional polypectomy. The EMR technique is preferable to conventional polypectomy for the complete resection of the large polyps (\>15 mm in diameter)
先天性心疾患を有する成人における患者報告アウトカム
The purpose of this study is to examine the differences in perceived health, psychosocial functioning, behavioral outcomes and quality of life of adults with congenital heart disease who are living in different areas of the world, and how these differences can be understood (e.g., differences in sense of coherence or illness perceptions).
未治療の進行性または転移性腎細胞癌におけるニボルマブとイピリムマブの併用とスニチニブの比較（CheckMate 214）
The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.
HCV誘発性肝硬変患者を対象としたPRI-724の非盲検単群用量漸増第1相試験
The purpose of this study is to investigate the safety and tolerability of PRI-724 in patients with HCV-induced cirrhosis.
2型糖尿病患者におけるイプラグリフロジンとインスリンの併用療法の有効性および安全性を評価する研究
The purpose of this study is to assess the efficacy (superiority to placebo) of ipragliflozin based on the changes in HbA1C, as well as its safety, in patients with type 2 diabetes mellitus in combination with an insulin preparation once daily for 16 weeks. The long-term (52 weeks) safety and the persistence of the efficacy will also be evaluated.
関節リウマチ（RA）患者におけるCHS-0214とエンブレル（エタネルセプト）の比較
This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies. Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety. Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.
DS-5573aの非盲検試験
This is an open-label, sequential dose escalation and expansion study to evaluate the safety, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.
小細胞肺癌におけるロニシクリブ／プラセボと化学療法の併用
This is a study to investigate the potential clinical benefit of roniciclib when given in combination with chemotherapy Carboplatin / Etoposide or Cisplatin / Etoposide as first line treatment in patients with extensive disease small cell lung cancer. Approximately 140 patients will be randomized (1:1) to receive treatment with either roniciclib or placebo in combination with chemotherapy. Roniciclib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. The growth of the tumor may be decreased by preventing these specific proteins from functioning. By specifically targeting these proteins, roniciclib in combination with chemotherapy may stop cancer growth. The primary endpoint (the most meaningful result to be tracked) of this study is based on the progression free survival, i.e. the time the disease is not worsening. The aim is to show that the therapy with roniciclib in combination with chemotherapy prolongs the time the disease is not worsening in this patient population compared to patients receiving placebo in combination with chemotherapy.
治療後の関節リウマチの状態評価
To examine the safety and effectiveness after Xeljanz treatment in rheumatoid arthritis patients
Bay1002670、子宮筋腫、安全性と有効性（EU、米国、カナダ、日本）
The study is performed to assess the efficacy and safety of different doses of BAY1002670 in subjects with uterine fibroids. The dose-response relationship will be evaluated. Further, the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the interchangeability of menstrual pictogram and alkaline hematin method for the judgement of menstrual blood loss will be assessed.
痛風または無症候性高尿酸血症の日本人患者を対象としたRDEA3170とプラセボの第II相用量探索試験
This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in greater reduction of sUA compared to placebo.
進行固形腫瘍を有する日本人患者におけるBI 836845の週1回静脈内投与
This open-label dose escalation phase I trial, 1280.15, is with the first administration of BI 836845 in Japanese patients with various types of advanced solid tumours. The rationale behind this study is to identify the maximum tolerated dose (MTD) of BI 836845 in Japanese patients with advanced solid tumours as weekly intravenous administration.
ステント留置を伴う経皮的冠動脈インターベンション（PCI）を受けた心房細動患者における、ダビガトランによる二剤併用療法とワルファリンによる三剤併用療法の比較評価（REDUAL-PCI）
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) \<= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome). The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.