治験一覧
8,963 件中 5781〜5800 件を表示
日本人健康被験者におけるCR6261の安全性、薬物動態および免疫原性を評価するための研究
The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the drug) and immunogenicity (ability of a particular substance to provoke an immune response in the human body) of CR6261 in Japanese healthy participants
コントロール不良の喘息を有する成人および青年におけるトラロキヌマブの有効性および安全性を評価する第3相試験
A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
2種類の錠剤におけるASP1941の経口吸収を比較する研究
To assess the bioequivalence of a single dose of ASP1941 between tablet-1 and tablet-2 in a two-way crossover method in non-elderly healthy male subjects. In addition, the safety of these products will be assessed.
インスリン療法で血糖コントロールが不十分な日本人2型糖尿病患者を対象に、ダパグリフロジン療法を追加した場合の有効性および安全性を評価するための、36週間の延長期間を含む第IV相試験。
Japanese male and female patients with Type 2 Diabetes and aged ≥ 20 years old, with inadequate glycemic control on insulin defined as Haemoglobin A1c ≥ 7.2% and \< 11% will be enrolled into the wash-out phase or directly into the lead-in phase depending on whether the patient has been receiving an Oral antidiabetic drug (including Glucagon-Like Peptide-1 agonists and excluding Thiazolidinedions) other than a Dipeptidyl Peptidase-4 inhibitor as part of the baseline treatment. Additional treatment with a concomitant Dipeptidyl Peptidase-4 inhibitor is allowed. And around 180 eligible patients in total will be randomized into the study with a 2:1 randomization scheme (i.e.120 patients into the dapagliflozin treatment group and 60 patients into the placebo treatment group. All subjects who completed a 16 weeks double-blind treatment period will shift to a 36 weeks open extension treatment period.
急性骨粗鬆症性椎体骨折患者における腰痛に対する椎体可動性の影響
Many patients with acute osteoporotic vertebral fracture (acute OVFs) admitted because of low back pain. But there are only part of patients with acute OVFs, because some patients do not have low back pain although OVFs occurred.
ポリープ状脈絡膜血管症に対するアフリベルセプト
To collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration
健康な日本人男性および白人男性を対象とした、D5884（オメガ3カルボン酸）の単回および複数回投与後の第1相臨床試験
The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884 following administration of single and multiple doses in healthy male Japanese subjects.
慢性心不全および左室収縮機能障害が悪化している患者、ならびに慢性腎臓病の有無にかかわらず2型糖尿病を合併している患者、または中等度の慢性腎臓病のみを合併している患者を対象とした、BAY94-8862の第IIb相安全性および有効性試験
This study will be conducted in subjects with clinical diagnosis of worsening chronic heart failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease (CKD) or moderate CKD alone treated with evidence-based therapy for heart failure (HF) for at least 3 months prior to emergency presentation to hospital using a multi-center, randomized, adaptive, double-blind, double-dummy, comparator-controlled, parallel-group design. Primary objective of the study is to investigate efficacy \[percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) of more than 30% from baseline to Visit 10 (Day 90)\] and safety of different oral doses of BAY94-8862 given once daily.
単純ヘルペス患者を対象としたASP2151の非盲検試験
A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes and Kaposi varicelliform).
残存肝機能に対するGSAの精度と信頼性
Preoperative evaluation of future remnant liver function is critical for patients undergoing hepatic surgery. Overestimation of the remnant liver function can lead to life-threatening postoperative hepatic failure, and its underestimation can lead to a lost opportunity for potentially curative surgery. Conventionally, post-hepatectomy remnant liver function has been estimated preoperatively using computed tomography (CT) volumetry. CT can provide precise anatomical information, and the remnant liver volume, measured by CT volumetry, has been reported to be an effective predictor of hepatic dysfunction after hepatectomy. However, the indirect estimation of liver function by CT volumetry is reliable only when the function is assumed to be homogenous over the whole liver.
高コレステロール血症の日本人被験者を対象としたボコシズマブ（PF-04950615；RN316）の用量設定試験
The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled.
再発性または転移性頭頸部癌におけるニボルマブと治験責任医師選択療法との比較試験（CheckMate 141）
The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.
門脈血栓症患者におけるNPB-06のプラセボ対照試験
Patients with portal vein thrombosis, who have chronic liver diseases especially liver cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06 or placebo. The superiority of NPB-06 to placebo as anticoagulative agent will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis. The safety of NPB-06 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and 21 days after administration in comparison with the placebo group.
再発性／再発または難治性骨髄異形成症候群（MDS）患者におけるSyB C-1101の安全性および薬物動態に関する研究
The purpose of this study is to investigate tolerability when SyB C-1101 is orally administered twice daily for 14 consecutive days to the patients with recurrent/relapsed or refractory myelodysplastic syndrome, to determine the dose-limiting toxicity and maximum tolerated dose, and to estimate the recommended dose for phase II studies. Pharmacokinetics and antitumor effects will also be investigated.
軽度アルツハイマー病患者を対象としたガンテネルマブの研究
Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE). A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.
原発性骨髄線維症（PM）、真性多血症後骨髄線維症（PV）、または本態性血小板血症後骨髄線維症患者におけるルキソリチニブの臨床試験
This is an open-label, multicenter clinical study in order to collect and examine data concerning the safety and efficacy of ruxolitinib in patients with Primary Myelofibrosis (MF), Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF.
非転移性去勢抵抗性前立腺癌患者におけるアパルタミド（ARN-509）の研究
この研究の目的は、高リスクの非転移性去勢抵抗性前立腺癌の成人男性におけるアパルタミドの有効性と安全性を評価することです。
再発性NMO患者を対象としたエクリズマブの非盲検延長試験
The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.
低用量アスピリン服用者における小腸出血を伴う小腸潰瘍の治癒に対するミソプロストールの効果を評価する
ASA is the most commonly drug used worldwide for prevention of cardiovascular diseases. However, ASA is increasingly recognized as a culprit for small bowel bleeding. Small bowel bleeding is notoriously difficult to diagnose because it is beyond the reach of conventional endoscopy. The advent of wireless, video capsule endoscopy has revolutionized the visualization of small bowel. Capsule endoscopy is a pill that contains a tiny camera for capturing pictures of the small bowel after being swallowed. Currently, capsule endoscopy is a recommended noninvasive approach of identifying the source of small bowel bleeding. Management of ASA-associated small bowel bleeding is a major clinical challenge since there is not a single effective treatment for small bowel ulcer, and continuation of ASA increases the risk of recurrent small bowel bleeding. However, discontinuation of ASA exposes patients to thrombotic complications. Suppression of prostaglandin synthesis is an important mechanism of ASA-induced small injury. Consistent with this theory, preliminary data from a case series showed that misoprostol, a prostaglandin analog, healed small bowel ulcers in ASA users. However, the efficacy of misoprostol in healing ASA-associated small bowel ulcers has not yet been confirmed by prospective randomized trials. This double-blind clinical trial tests the hypothesis that misoprostol can heal small bowel ulcers in Aspirin users complicated by small bowel bleeding.
ラニビズマブとアフリベルセプトの再発までの時間の比較
The investigators compared the time to recurrence after ranibizumab or aflibercept loading in patients with AMD.