治験一覧
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アジルサルタン錠（アジルバ錠）特別薬物使用監視「糖尿病合併高血圧」
The purpose of this study is to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with angiotensin II receptor blockers (ARBs) other than azilsartan, in routine clinical practice
オメガ3脂肪酸エチルエステルの長期使用における安全性と有効性の評価
The purpose of this study is to evaluate the safety and efficacy of long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in patients with hyperlipidemia in daily medical practice
抗ドナー抗体陽性レシピエントに対するGB-0998を用いた脱感作療法。
It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization. Patients with positive FCXM-T after performing twice double filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.
黄斑偽孔における中心窩錐体外節先端線状欠損
Evaluation of recovery in foveal cone outer segment tips line defect and visual acuity after surgery for macular pseudohole
健康な成人男性におけるCNTO 3649の単回投与および2型糖尿病患者におけるCNTO 3649の複数回投与の安全性、薬物動態および薬力学に関する研究
The purpose of this study is to investigate the safety (adverse events, weight, blood pressure, pulse rate, body temperature, abdominal ultrasonography, standard 12-lead electrocardiography, and laboratory tests) of CNTO 3649 when administered once by subcutaneous injection in healthy adult Japanese men or once a week for 4 weeks in Japanese participants with type 2 diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects).
ギラン・バレー症候群患者を対象としたNPB-01の第III相臨床試験
Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Patients evaluate the Functional Grade（FG） and Arm Grade（AG） et al. As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by the start of the study treatment.
駆出率低下を伴う心不全で慢性心不全が悪化している患者を対象とした、BAY1021189の4つの投与レジメンの安全性および有効性に関する第IIb相試験（SOCRATES-REDUCED）
Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).
急性骨髄性白血病の高齢患者におけるOCV-501の有効性および安全性を評価する第2相臨床試験
To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.
膵臓がんにおけるNC-6004とゲムシタビンの併用療法とゲムシタビン単独療法との比較
This clinical trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer in Asian countries.
HLA-A*02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 a novel HLA-A\*0201-restricted epitope peptide, which was derived from a cancer-testis antigen, URLC10 as a target for vaccination against lung cancer. In this clinical study, the investigators examine using the peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A\*0201-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.
TOFOインスリン併用療法の臨床試験
Primary Objectives: To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over a period of 16 weeks in patients with type 2 diabetes mellitus. To assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks. Secondary Objectives: To assess the effects of tofogliflozin in comparison to placebo on: * Body weight * Fasting plasma glucose (FPG) * Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of tofogliflozin.
血友病B患者における凝固因子IXとアルブミンを連結した組換え融合タンパク質（rIX-FP）の安全性および有効性に関する延長試験
This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B. The study will include subjects who have not previously been treated with Factor IX products, subjects who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study. A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with hemophilia B who are undergoing non-emergency major or minor surgery. An additional substudy will examine the safety and PK of subcutaneous (SC) administration of rIX-FP.
進行性固形腫瘍患者を対象としたDS-8895aの第1相臨床試験
This is an open-label, sequential dose escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of DS-8895a in Japanese subjects with advanced solid tumors.
日本における血友病Aの長期治療におけるNovoEight®（rFVIII）の安全性および有効性を調査する
This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine clinical practice.
胃癌に対する一次治療としてのリロツムマブ（AMG 102）とシスプラチンおよびカペシタビン（CX）の併用療法に関する第3相試験
This is a Phase 3, multicenter, randomized, double-blind, placebo controlled study of Rilotumumab (AMG 102) with Cisplatin and Capecitabine (CX) for untreated advanced mesenchymal epithelial transition factor (MET)-positive gastric or gastroesophageal junction adenocarcinoma (GEJ).
大腿浅動脈および／または膝窩動脈近位部の動脈硬化性病変の治療における、MDT-2113薬剤溶出バルーンと標準PTAの比較
The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the interventional treatment of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the proximal popliteal artery (PPA) as compared to treatment with standard percutaneous transluminal angioplasty (PTA).
発作性または持続性心房細動（AF）患者に対するOPC-108459の単回静脈内投与の安全性、薬物動態、および有効性を決定するための試験
To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to patients with paroxysmal or persistent atrial fibrillation
急性硬膜下血腫患者における早期冷却の効果を研究する
This randomized, prospective trial will study the effect of very early cooling in patients undergoing surgical evacuation of acute subdural hematomas (35°C prior to opening the dura followed by maintenance at 33°C for a minimum of 48h). Intravascular cooling catheters (Thermogard XP Device, Zoll) will be utilized to induce hypothermia or to maintain normothermia. The primary objective is to determine if rapid induction of hypothermia prior to emergent craniotomy for traumatic subdural hematoma (SDH) will improve outcome as measured by Glasgow Outcome Scale-Extended (GOSE) at 6 months.
日本人2型糖尿病患者におけるエンパグリフロジンの食後血糖値（PPG）に関する研究
To evaluate the efficacy of empagliflozin administered orally once daily in postprandial glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic control on no antidiabetic treatment.
再発性／再発性または難治性骨髄異形成症候群（MDS）患者におけるSyB C-1101の長期安全性試験 - 延長試験
This is an extension study to investigate long term safety and efficacy of SyB C-1101 when orally administered every 3 weeks, twice daily for 14 consecutive days to the patients who have completed 6 cycles in the study 2012002 whose purpose is to investigate tolerability of SyB C-1101 when administered orally in patients with recurrent/relapsed or refractory myelodysplastic syndrome.