治験一覧
8,963 件中 5621〜5640 件を表示
日本人慢性心不全患者における心不全に対するビソプロロールの効果に関する研究（CIBIS-J）
The purpose of this study is to investigate the non-inferiority of bisoprolol to carvedilol by evaluating tolerability (The probability that administered maintenance dose reaches the maximum will be determined as an indicator) as a primary endpoint when bisoprolol or carvedilol is administered for 48 weeks to Japanese chronic heart failure patients. In addition, the safety and efficacy of bisoprolol will be investigated.
[SOCRATES - アスピリンまたはチカグレロルで治療された急性脳卒中または一過性脳虚血発作と患者の転帰]
The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg \[two 90 mg tablets\] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg \[three 100 mg tablets\] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction \[MI\], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).
トランスサイレチン心筋症患者におけるタファミジスの安全性と有効性
This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.
中等度から重度の潰瘍性大腸炎患者における2種類のアダリムマブ投与レジメンの安全性と有効性を評価する研究
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
健康な日本人被験者を対象としたバリシチニブの研究
The purpose of this study is to understand the relationship of 3 different dosage forms of baricitinib. This study will also explore the effect of food on how the body absorbs baricitinib. This study will last about 5 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.
間質性肺炎患者におけるプログラフカプセルの長期使用に関する調査
This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.
喘息患者を対象としたメポリズマブの第3a相反復投与非盲検長期安全性試験
This is a multi-center, open-label, long-term study of subcutaneously (SC) administered mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic asthma. This study will enroll a subset of subjects from Study MEA115661 who have demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy are individuals at greatest risk of serious deterioration of their health status. In order to target individuals at greatest risk for serious deterioration of their health status, only subjects from the MEA115661 study with a history of life-threatening or seriously debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility criteria for the study will be offered the opportunity to consent for this study of up to 128 weeks in length (including the Follow-Up Visit). This study will give opportunity to extend the collection of clinical data for long-term use and further assess the sustainability of efficacy in a population likely to experience significant loss of asthma control and the need for higher doses of systemic steroids if returned to SOC only.
リセドロン酸ナトリウム錠（ベネット75mg錠）の長期使用に関する特別薬物使用監視調査（12ヶ月治療調査）
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine "the status of treatment compliance" - i.e., whether sodium risedronate tablets are taken properly in accordance with the prescribed once-monthly regimen
急性心不全における標準治療へのセクセラキシンの追加投与の有効性、安全性および忍容性
The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.
呼吸器合胞体ウイルス関連下気道感染症で入院した日本人小児を対象とした研究
The purpose of the study is to assess viral kinetics and clinical symptoms kinetics of Respiratory Syncytial Virus (RSV) in pediatric patients hospitalized with RSV confirmed lower respiratory tract infection (LRTI).
ハッピーナースプロジェクト：病院看護師の健全な精神状態を維持するためのライフスタイル介入
The study is to explore the effectiveness of omega-3 fatty acids and mindfulness-based stress management program to maintain healthy mental state in hospital nurses. The participants will be junior nurses who work in inpatient wards and are not clinically depressed. The participants will be randomly allocated to four intervention arms: 1) Mindfulness-based stress management program plus omega-3 fatty acids pills ; 2) Mindfulness-based stress management program plus placebo pills; 3) Psychoeducation leaflet plus omega-3 fatty acids pills; and 4) Psychoeducation leaflet plus placebo pills. Thirty participants will be allocated to each arm. These interventions will terminate until three months from registration for each participant. Information about depression and anxiety symptoms (primary outcome), insomnia, burnout, presenteeism, quality of life, sick leave, consultation about mental state of herself, and oxidative stress will be collected at 3 months, 6 months (primary time point) and 12 months from registration for each participant.
日本人アレルギー性結膜炎患者におけるAGN-229666点眼液の効果
This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.
高トリグリセリド血症を伴う高心血管リスク患者におけるEpaNovaによるスタチン残存リスク低減効果を評価するアウトカム研究
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
皮膚筋炎におけるBAF312の安全性と有効性
This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal clinical effect. The study was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of 2 mg daily .
非弁膜症性心房細動を有する日本人患者におけるエリキュースの安全性監視
The primary objectives of this study are: * To estimate the incidence rate of unexpected adverse events * To characterize the bleeding events and assess risk factors of bleeding * To identify ancillary baseline variables that may also be associated with adverse outcomes
活動性関節リウマチ患者を対象としたPF-06438179（インフリキシマブ-ファイザー）およびインフリキシマブとメトトレキサートの併用療法に関する研究（REFLECTIONS B537-02）。
The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.
日本人新生血管性加齢黄斑変性症患者におけるアビシパーペゴルの有効性に関する研究
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.
固形腫瘍の治療における抗LAG-3と抗PD-1の併用および非併用の安全性、忍容性および有効性を評価するための治験的免疫療法研究
The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
PPI抵抗性胃食道逆流症患者に対する維持療法におけるE3810 10mgの1日1回投与と1日2回投与の有効性および安全性に関する二重盲検比較試験
The purpose of this study is to assess the efficacy and safety of rabeprazole 10mg once and twice daily in maintenance therapy for PPI resistant gastroesophageal reflux disease patients.
膣口のViveve治療の効果を評価する
Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design The objective of this study is to determine the safety and effectiveness of the Viveve System to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving vaginal laxity.