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二重抗血小板療法の短期および最適期間に関する第2相試験

完了NCT02619760第4相

The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES).

対象疾患:
Coronary Artery Disease

去勢抵抗性前立腺癌患者におけるエンザルタミドとフルタミドに関する研究

完了NCT02918968第4相

The objective of this study was to compare the efficacy and safety of the combination therapy with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with flutamide + ADT in patients with castration resistant prostate cancer who had relapsed during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study also investigated the order of alternative antiandrogen therapy (AAT) by changing the 1st line medication after relapse of prostate-specific antigen (PSA).

対象疾患:
Prostate Cancer

進行性悪性腫瘍患者を対象とした、MBG453単剤療法およびPDR001との併用療法に関する第I-Ib/II相試験

中止NCT02608268第1/第2相

The purpose of this first-in-human study of MBG453 was to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453 administered i.v. as a single agent or in combination with PDR001 or decitabine in adult patients with advanced solid tumors

対象疾患:
Advanced Malignancies

高カリウム血症患者におけるZSの安全性と有効性を調査する研究

完了NCT02875834第3相

To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following two days of initial ZS therapy (10g TID).

対象疾患:
Hyperkalemia

QuQuスケールの妥当性に関する検証研究および反応性研究

完了NCT02667665

Examine the construct validity, the test-retest reliability, the concurrent validity with the standard dementia rating scales and the reactivity of a novel dementia rating scale "QuQu scale: QUick QUestion scale" final for the evaluation of patients with Alzheimer's Disease Dementia and Mild Cognitive Impairment.

対象疾患:
Alzheimer's Disease DementiaCognitive Concern Without Dementia

健康な男性被験者におけるブレクスピプラゾール口腔内崩壊錠の生物学的利用能の評価研究

完了NCT02875080第1相

The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).

対象疾患:
Healthy Adult Male

肺胞蛋白症に対するGM-CSF吸入療法の有効性に関する日本国内臨床試験

完了NCT02835742第2相

Objective: Determine the safety and efficacy of GM-CSF inhalation in patients with aPAP. Study Design: multi-center, randomized, double-blind, placebo- controlled, safety/efficacy study.

対象疾患:
Pulmonary Alveolar Proteinosis, Autoimmune

大腸癌における最適な腸管切除範囲と中心切除率に関する国際前向き観察コホート研究

完了NCT02938481

The T-REX study aims to clarify the actual status of metastatic lymph node (LN) distribution in colon cancer and provide reliable evidence regarding the optimal length of bowel resection and the extent of central lymph node dissection in colon cancer surgery.

対象疾患:
Colon Cancer

再発性または難治性の高悪性度神経膠腫を有する小児患者におけるDSP-7888の研究

完了NCT02750891第1/第2相

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with recurrent and relapsed diffuse intrinsic pontine glioma, glioblastoma, or grade III or IV glioma.

対象疾患:
Diffuse Intrinsic Pontine GliomaGlioblastoma

進行性/転移性または外科的切除不能な胆管癌患者におけるペミガチニブの有効性と安全性(FIGHT-202)

完了NCT02924376第2相

The purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.

対象疾患:
Cholangiocarcinoma

子宮筋腫の治療におけるレルゴリクス(TAK-385)40mgとリュープロレリンの有効性および安全性を比較評価する第3相試験

完了NCT02655237第3相

The purpose of this study is to evaluate the efficacy of Relugolix (TAK-385) 40 mg administered orally once daily for 12 weeks, compared with leuprorelin injection (once every 4 weeks, 1.88 mg or 3.75 mg subcutaneously \[SC\]/time) in patients with uterine fibroids.

対象疾患:
Uterine Fibroids

食道癌または胃食道接合部癌切除患者を対象としたニボルマブまたはプラセボの免疫療法試験

完了NCT02743494第3相

The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

対象疾患:
Advanced Cancer

再発・難治性原発性中枢神経系リンパ腫(PCNSL)および再発・難治性原発性精巣リンパ腫(PTL)におけるニボルマブの有効性に関する研究

完了NCT02857426第2相

The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)

対象疾患:
Lymphoma

片頭痛を有する日本人参加者を対象としたLY2951742(ガルカネズマブ)の研究

完了NCT02959190第3相

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as Galcanezumab in Japanese participants with migraine.

対象疾患:
Migraine

C型肝炎ウイルス遺伝子型1に感染した患者における薬物使用結果調査

完了NCT02629172

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily practice in Japan.

対象疾患:
Chronic Hepatitis C Virus

健康な日本人男性被験者を対象とした、ナルメフェン10mg錠の安全性、忍容性、および薬物動態特性を調査する単施設、非盲検、単回投与試験

完了NCT02679469第1相

The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.

対象疾患:
Alcohol Dependence

未治療の転移性結腸直腸癌患者を対象としたBI 695502の非盲検単群試験

完了NCT02776683第3相

The objective of this trial is to evaluate the safety and tolerability of BI 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy (when applicable). As well as to evaluate the following efficacy parameters: Progression-free survival (PFS), objective response rate (proportion of patients with complete response \[CR\] plus partial response \[PR\]), overall survival (OS), duration of response (DOR), time to progression (TTP).

対象疾患:
Colorectal Neoplasms

シタグリプチンを服用中の日本人2型糖尿病患者におけるDS-8500aの有効性に関する研究

完了NCT02685345第2相

The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.

対象疾患:
Type 2 Diabetes Mellitus

2型糖尿病患者における経口セマグルチドとリラグルチドおよびプラセボの有効性および安全性

完了NCT02863419第3相

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes Mellitus.

対象疾患:
DiabetesDiabetes Mellitus, Type 2

IgG4関連硬化性胆管炎の検出における胆汁の有用性

完了NCT02616705

Immunoglobulin G4-related disease (IgG4-RD) is an uncommon inflammatory disorder that may affect multiple organ systems, including the biliary tree. IgG4-sclerosing cholangitis (IgG4-SC) can be difficult to distinguish from primary sclerosing cholangitis (PSC) or cholangiocarcinoma (CCA). The investigators aim to evaluate the sensitivity and specificity of bile for the diagnosis of IgG4-SC. Bile samples of patients with biliary strictures of various causes, including IgG4-SC, PSC, and CCA, will be collected during clinical cholangiography procedures. IgG4 will be measured in bile specimens and bile IgG4 concentrations compared between IgG4-SC, PSC, CCA, and other types of biliary strictures.

対象疾患:
IgG4-related DiseaseIgG4-related Sclerosing Cholangitis