治験一覧
8,963 件中 5541〜5560 件を表示
TBI-1201の医師主導型第1相臨床試験
Following pre-treatment with cyclophosphamide and/or fludarabine, MAGE-A4-specific TCR gene transduced T lymphocytes are transferred to the patients with MAGE-A4-expressing solid tumors.
アログリプチン錠の特別薬物使用監視「2型糖尿病：α-GIとの単剤療法／併用療法」
The purpose of this study is to determine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor. In addition, examining the safety and efficacy of alogliptin in patients with renal impairment, information on the appropriate dosage of alogliptin according to the severity of impaired renal function should be collected.
ミラベグロンがトルテロジンの血漿中濃度に及ぼす影響を評価する市販後調査
To assess the effect of multiple doses of mirabegron to postmenopausal adult female subjects on the pharmacokinetics (PK) of tolterodine and its metabolites. In addition, the safety of these products will be assessed.
KUX-1151の第II相探索的臨床試験
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.
骨粗鬆症の男性におけるロモソズマブ（AMG 785）とプラセボの安全性および有効性を比較する研究
The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.
非ホジキンリンパ腫の日本人患者における末梢造血幹細胞の動員および採取のためのプレリキサフォルと顆粒球コロニー刺激因子の併用療法
Primary Objective: To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 5 x 10\^6 cluster differential (CD) 34+ cells/kg in 4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone. Secondary Objectives: * To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in NHL participants. * To compare the 2 treatment arms with respect to the number of participants who achieved a minimum of 2 x 10\^6 CD34+ cells/kg in 4 or fewer days of apheresis. * To compare the 2 treatment arms with respect to the number of days of apheresis required to reach the target of greater than or equal to 5 x 10\^6 CD34+ cells/kg.
日本の就学前児童を対象とした、IMOVAX POLIO®皮下注射ワクチンの追加接種に関する研究
The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose. Primary Objective: * To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster Secondary Objectives: * To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR). * To investigate the safety after dosing of SP059 as 2nd booster.
第2世代320列CTにおける心臓CTの適切性の評価
The influence of the second-generation 320-row area-detector CT (ADCT) on the clinical indications and appropriateness of cardiac CT has not been adequately investigated. The purpose of the survey is to assess the distribution of appropriateness ratings and test outcomes of cardiac CT with second-generation ADCT.
骨粗鬆症治療後の骨代謝マーカーおよび骨密度の変化
To examine the changes of bone mineral density and bone turnover markers after Bonviva treatment in osteoporotic patients
日本人集団におけるデイリーズトータル1®レンズのセンタリング
The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.
心房細動および冠動脈ステント留置患者における抗血栓療法の最適化（OAC-ALONE）研究
The purpose of the study is to evaluate non-inferiority of oral anticoagulant (OAC) monotherapy to OAC plus single antiplatelet therapy (APT) in patients with atrial fibrillation (AF) and prior (\>12 months) coronary stenting.
中等度から重度の良性前立腺肥大症の男性における、デュタステリドとタムスロシンの併用療法とタムスロシン単剤療法の有効性および安全性を比較する研究
This is a multicentre, randomised, double-blind, parallel group study in Asian subjects. The aim of the study is to investigate whether combination therapy with dutasteride and tamsulosin is more effective than tamsulosin monotherapy for the improvement of symptoms and health outcomes in an at risk population of benign prostatic hyperplasia (BPH) clinical progression including older men (\>=50 years), with moderate-severe symptoms of BPH, enlarged prostates (\>=30 cubicentimeter \[cc\]) and prostate specific antigen (PSA) \>= 1.5 nanograms per milliliter (ng/mL). Each subject who met the eligibility criteria at screening will enter a four-week single-blind, placebo run-in period following which each subject will be randomised into a 2 year double-blind treatment phase. The total study duration for each subject will be up to 110 weeks.
原発性高コレステロール血症の日本人被験者におけるエバセトラピブ（LY2484595）の有効性に関する研究
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as evacetrapib in Japanese participants with primary hypercholesterolemia. The double blind treatment period will last for 12 weeks and the open-label extension period will last for an additional 40 weeks.
HLA-A*24疾患をコントロールした進行非小細胞肺癌に対するエピトープペプチドの安全性および有効性に関する研究
The investigators previously identified three novel HLA-A\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for vaccination against lung cancer. In this clinical study, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A\*2402-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.
機能性消化不良患者における六君子湯の有効性および安全性に関する研究
The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia (FD).
中等度の腎機能障害を有するむずむず脚症候群（RLS）患者におけるガバペンチンエナカルビルの効果を評価するための市販後調査
To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to severe primary RLS patients with moderate renal impairment and to confirm dosage and administration in such population.
双極性I型障害患者におけるSM-13496の長期研究。
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
再発性または難治性の進行性B細胞悪性腫瘍を有する日本人成人患者を対象としたMEDI-551の第1相用量漸増試験
The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.
胃腸酸関連疾患を有する日本人小児患者を対象としたD961H 10mgおよび20mgの第I/III相臨床試験
The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome.
高齢者における基礎インスリンへのリナグリプチンの追加投与
To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors is also allowed. In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when added to background basal insulin therapy. The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in glycosylated Haemoglobin, a well-accepted measurement of chronic glycaemic control.