治験一覧
8,963 件中 5901〜5920 件を表示
原因不明の塞栓性脳卒中患者における二次性脳卒中予防のためのダビガトランエテキシラート（RE-SPECT ESUS試験）
This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).
進行がんを患う日本人参加者を対象としたLY2835219の研究
The main purpose of this study is to evaluate safety and side effects of LY2835219 in Japanese participants with advanced cancer.
ROS1陽性、ALK陰性の進行非小細胞肺癌を有する東アジア人患者を対象としたクリゾチニブの第II相安全性および有効性試験
To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation
記憶喪失のリスクがある高齢者を対象としたソラネズマブの臨床試験
The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (protein that forms plaques in the brains of people with Alzheimer Disease \[AD\]).
自家幹細胞移植後の多発性骨髄腫患者における経口イキサゾミブクエン酸塩（MLN9708）維持療法に関する研究
The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response \[CR\], very good partial response \[VGPR\], or partial response \[PR\]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).
日本人患者におけるテリパラチド療法後のビスホスホネートおよびデノスマブ療法の臨床結果
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of bisphosphonate and denosumab randomly divided following daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.
大腿骨の加齢に伴う認知機能の変化
Age-related change of femur is not well-known. The investigators investigated the longitudinal changes of femur.
アログリプチン／ピオグリタゾン（リオベル）配合錠の2型糖尿病患者における長期使用に関する調査
The purpose of this survey is to examine the safety and efficacy of long-term use of alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus determined as warranting combination therapy with alogliptin benzoate and pioglitazone hydrochloride
健康な乳児を対象としたTAK-816の筋肉内投与に関する第III相試験
The purpose of this study is to evaluate the safety and immunogenicity of intramuscular TAK-816 in healthy Japanese infants.
健康な成人男性ボランティアにおけるOPC-1085EL点眼液の薬物動態学的研究
OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.
アログリプチン錠特定薬剤使用調査「血糖降下薬（例：インスリン製剤または速効型インスリン分泌促進薬）との併用療法を受けている2型糖尿病患者」
The purpose of this survey is to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues)\* in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care. \* Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use surveys for alogliptin tablets.
脈絡膜内空洞形成を伴う黄斑剥離
Evaluation of clinical characteristics and surgical outcome for macular detachment associated with peripapillary intrachoroidal cavitation with or without pathologic myopia.
良性前立腺肥大症患者におけるASP4901の有効性および安全性を評価する研究
The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.
長期耐久性に関する研究。ボストン・サイエンティフィック社が市販したICDおよびCRT-Dデバイスのデバイスおよびバッテリーの寿命評価
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices. It will also validate the device survival information given in Boston Scientific's Product Performance Report by comparing the pulse generator (PG) survival probability in the study to that presented in the Product Performance Reports (PPR)
KHK7580の第2相試験
This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.
日本人未分化甲状腺癌または髄様甲状腺癌患者を対象としたソラフェニブ第II相臨床試験
The objectives of this study are to evaluate safety, efficacy and pharmacokinetics of sorafenib for the treatment of Japanese patients with anaplastic thyroid carcinoma (ATC) or locally advanced or metastatic medullary thyroid carcinoma (MTC).
パーキンソン病患者における非運動症状および治療に関する観察研究
This study is implemented to identify factors having an impact on improvement or exacerbation of non-motor symptoms, to provide information contributing to development of medical care in this field and improvement of patients' QOL, and to clarify the association between the use of istradefylline and non-motor symptoms or QOL.
慢性血栓塞栓性肺高血圧症（CTEPH）に対するリオシグアトの市販後安全性に関する前向き非介入多施設共同研究
This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of 400 patients (valid for safety analysis). This study is performed as an all-case investigation. The treatment of Riociguat is performed based on the product label in Japan. The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is carried out once a year for 7 years at the longest to collect information on safety and effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is terminated, observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC) system. The duration of the study is approximately 9 years from launch.
インスリン グラルギンとの併用におけるリキシセナチドとシタグリプチンの比較による食後血糖値への影響
Primary Objective: To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a standardized breakfast from baseline to Day 29. Secondary Objectives: To demonstrate: * Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion, C-peptide and glucagon levels after a standardized breakfast * Delaying gastric emptying (13C-acetic acid breath test) * Safety and tolerability
網膜動脈瘤に伴う黄斑下出血
Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial macroanuerysms.