治験一覧
8,963 件中 6101〜6120 件を表示
血液透析を受けている患者における二次性副甲状腺機能亢進症に対するKHK7580の第1/2相試験
This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients receiving hemodialysis
健康な日本人男性被験者を対象とした、MEDI9929の単回投与後の安全性、忍容性、薬物動態および免疫原性を評価する第1相試験
The purpose of this study is to assess safety, tolerability, pharmacokinetics and immunogenicity of MEDI9929 following administration of single ascending doses in healthy male Japanese subjects.
モリブデン補因子および単離亜硫酸オキシダーゼ欠損症の自然史研究
Primary objective: Characterize the natural history of MoCD type A in terms of survival Secondary objectives: 1. Evaluate blood and urine for biochemical markers 2. Evaluate head circumference, seizure activity and neurologic outcomes 3. To evaluate brain MRI 4. Compare blood and urine analysis, head circumference, seizure activity and neurologic outcomes to MRI findings
分化型甲状腺癌患者におけるバンデタニブの有効性および安全性の評価
Primary Objective: To determine the efficacy (as assessed by progression-free survival \[PFS\]) of vandetanib when compared to placebo in participants with differentiated thyroid cancer that is either locally advanced or metastatic who are refractory or unsuitable for radioiodine therapy. Secondary Objectives: * To determine the efficacy of vandetanib when compared to placebo in this participant population as assessed by efficacy variables including duration of response (DOR), objective response rate (ORR), change in tumour size (TS) and overall survival (OS). * To evaluate the pharmacokinetics (PK) of vandetanib in this participant population and potentially investigate any influence of participant demography and pathophysiology on vandetanib PK. * To demonstrate an improvement in time to worsening of pain (TWP) in participants treated with vandetanib when compared to placebo in this participant population. * To evaluate the safety and tolerability of vandetanib treatment in this participant population.
日常臨床におけるシプロキサン静注製剤の安全性および有効性の評価 - 市販後調査の分析結果
This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A total of 3,000 patients are to be enrolled and assessed during the period of treatment with Ciproxan.
二次進行型多発性硬化症患者におけるシポニモドの有効性と安全性の検討（EXPAND）
Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).
透析を受けていない高リン血症を伴う慢性腎臓病患者を対象とした長期研究
This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease patients with hyperphosphatemia not on dialysis.
BI 201335 NAソフトゼラチンカプセルの2種類の用量強度における生物学的同等性試験
The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.
日本人における血管過多性腫瘍患者および動静脈奇形患者を対象としたE7040の多施設共同非盲検試験
To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in Japanese subjects with hypervascular tumor or arteriovenous malformation
癌性浮腫患者におけるOPC-41061の有効性、薬物動態、薬力学、および安全性を調査するための多施設共同非盲検用量探索試験（第2相）
OPC-41061 will be administered to patients with volume overload associated with cancer, first by dose-escalation and subsequently for 6 consecutive days at the fixed dose at which urine volume is increased to investigate efficacy, pharmacokinetics, pharmacodynamic effects, and safety and to determine the effective initial and maintenance doses of OPC-41061.
下肢整形外科手術を受ける重度腎機能障害患者へのDU-176b投与に関する安全性および薬物動態学的研究
To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of the lower limbs. For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of the lower limbs will be compared with that of fondaparinux.
大動脈弁輪が小さく、症候性重度大動脈弁狭窄症の患者におけるMDT-2111の臨床評価
The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for surgical operation.
日本人関節リウマチ患者におけるサリルマブとメトトレキサートの安全性および忍容性に関する単回漸増投与試験
Primary Objective: To assess the safety and tolerability of a single dose of subcutaneously administered sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant treatment with methotrexate. Secondary Objective: To assess the pharmacokinetic profile of a single subcutaneous (SC) dose of sarilumab in Japanese RA patients.
再発または再発性成人T細胞白血病・リンパ腫患者を対象としたレナリドミドの第2相試験
To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma (ATL) who have previously received chemotherapy for ATL.
大うつ病性障害患者における経口複数回投与試験
A study was to evaluate the safety and plasma concentration changes of quetiapine after repeated administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD).
百日咳およびその他の感染症の血清疫学的研究
Serum samples will be corrected twice from the same youth subjects with one year interval. Seroincidence of pertussis will be estimated by the elevation of Ig-G-PT in paired sera from an identical individual. The relationship between the incidence and the demographic data or medical history of the subjects will be discussed.
閉経後女性におけるER陽性、HER2陰性の転移性または局所進行性乳がんに対するエベロリムスとレトロゾールの併用療法に関する非盲検第II相試験
The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. Moreover, the study also aimed to investigate the efficacy and safety of second line treatment with everolumus plus examestane in participants whose disease progressed during everolimus plus letrozole therapy.
日本における目尻のしわ治療におけるボトックス®の使用
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).
吸入ステロイド薬と別の維持療法薬を服用しているにもかかわらず喘息がコントロールされていない患者を対象としたレブリキズマブの研究
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.
慢性腎不全で血液透析または血液濾過を受けている患者におけるOPC-41061の有効性、安全性、薬物動態、および薬力学を調査するための第2相多施設共同非盲検用量探索試験
To investigate the safety, pharmacokinetics, pharmacodynamics, and efficacy of OPC-41061 in patients with chronic renal failure undergoing hemodialysis or hemodiafiltration using variables, such as daily urine volume and increase in interval body weights between hemodialysis or hemodiafiltration, in 4-day intermittant administration (excluding the days of hemodialysis or hemodiafiltration) at the dose fixed during the dose-escalation period