治験一覧
8,963 件中 5361〜5380 件を表示
非小細胞肺癌患者を対象としたネシツムマブ（LY3012211）とペムブロリズマブ（MK3475）の併用療法に関する研究
The main purpose of this study is to evaluate the safety and efficacy of the combination of necitumumab with pembrolizumab in participants with stage IV non-small cell lung cancer (NSCLC).
日本人2型糖尿病患者を対象としたMP-513の単剤療法およびスルホニル尿素剤との併用療法による長期安全性試験
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.
FYU-981の臨床薬理（腎機能不全患者）
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with renal insufficiency and with normal renal function.
健康な成人男性被験者におけるSYR-322とメトホルミン塩酸塩の固定用量配合剤の単回経口投与時の薬物動態に対する食物の影響
This is a randomized, open-label, crossover study to determine the effect of food when a combination tablet of SYR-322 and metformin hydrochloride ( hereinafter referred to as SYR-322-MET tablet) is orally administered under fasting conditions in the morning or after breakfast in Japanese healthy adult male subjects.
レトシバン治療研究に参加した母親から生まれた乳幼児の長期的な安全性と転帰を評価するための追跡調査
The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) treatment studies, to provide assurance that treatment is not associated with significant adverse outcomes in early childhood. The enrolled infants and children will be followed at pre-specified intervals until they reach 24 months chronological age. This study does not require medical interventions or study visits to an investigational site, instead, parents or legal guardians will be prompted at certain time points to complete developmental questionnaires and other data on their children's health status via an electronic device. Data collected during the infant and child follow up study will be managed by a centralized research coordinating center (RCC). Regionally based pediatricians will serve as study principal investigators (referred to as RCC-PIs) for this study. All communications the RCC-PI has with the parent/legal guardian or the child's health care provider (HCP) will occur remotely; there will be no clinic visits.
全身性硬化症（SSc）患者におけるトシリズマブの有効性および安全性に関する研究
This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.
活動性関節リウマチ患者を対象としたPF-06410293（アダリムマブ-ファイザー）およびアダリムマブ（ヒュミラ®）とメトトレキサートの併用に関する研究（REFLECTIONS B538-02）。
The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate. In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.
進行胃癌患者を対象としたTAS-118＋オキサリプラチンとS-1＋シスプラチンを比較する第III相試験
The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.
2歳から6歳までの健康な日本人小児を対象とした、MEDI3250の安全性を評価する第3相非盲検試験
This open-label, single arm, multicenter study will enroll approximately 100 subjects. The study is designed to gather the safety and tolerability data in Japanese children 2 to 6 years of age that would support approval of MEDI3250 in Japan.
アルツハイマー型認知症の発症リスクがある無症状の被験者におけるアタベセスタットの有効性と安全性に関する研究
The purpose of this study is to evaluate whether treatment with atabecestat slows cognitive decline compared with placebo treatment, as measured by a composite cognitive measure, the Preclinical Alzheimer Cognitive Composite (PACC), in amyloid-positive participants who are asymptomatic at risk for developing Alzheimer's dementia.
SP0994試験を完了した被験者におけるラコサミド単剤療法としての長期使用を調査する臨床試験
Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 \[NCT01465997\]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.
ウイルス関連腫瘍におけるニボルマブおよびニボルマブ併用療法の安全性と有効性を調査する治験免疫療法研究
The purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors: * Anal canal cancer-No longer enrolling this tumor type * Cervical cancer * Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type * Merkel Cell Cancer * Penile cancer-No longer enrolling this tumor type * Vaginal and vulvar cancer-No longer enrolling this tumor type * Nasopharyngeal Cancer - No longer enrolling this tumor type * Head and Neck Cancer - No longer enrolling this tumor type
切除不能進行性または再発性胃癌におけるONO-4538の研究
The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.
磁気共鳴血管造影に基づく頭蓋内動脈狭窄症に対するロスバスタチン治療
The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis.
膵尾部切除術における強化ステープルに関する前向き多施設共同試験
The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.
血糖コントロールが不十分な1型糖尿病患者におけるダパグリフロジンの評価
The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.
7歳から18歳までの健康な日本人小児を対象とした、MEDI3250の有効性および安全性を評価する第3相臨床試験
The study is designed to gather the efficacy, safety and tolerability data in Japanese children 7 to 18 years of age that would support approval of MEDI3250 in Japan.
低リン酸血症（HPP）患者におけるアスフォターゼアルファの安全性と有効性
The aim of this study is to assess safety and efficacy of Asfotase Alfa (ALXN1215) in patients with hypophosphatasia
併用アンドロゲン遮断療法（CAB）後の去勢抵抗性前立腺癌（CRPC）に対する代替抗アンドロゲン（AA）療法とエンザルタミドの早期開始に関する比較研究。
The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC after treatment with Bic-CAB will be investigated.
日本人乳幼児におけるDTaP-IPV/Hibワクチンの初回接種および追加接種とDTaP-IPVとHibワクチンの同時接種の比較
Primary objective: * To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary vaccination (all antigens). Secondary objectives: * To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4) in the two study groups (Group A and Group B). * To describe the safety after each dose of each vaccine in the two study groups (Group A and Group B). * To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4 (Group C)