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慢性腎臓病の透析前患者におけるダルベポエチン投与による貧血の維持療法とBAY85-3934との比較
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin. The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease. The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 15 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests. The study will be conducted at 3 hospitals in the UK. Bayer HealthCare AG is funding this research.
単純ヘルペス患者を対象としたASP2151の第III相臨床試験
To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.
脂質低下療法を併用している日本人ホモ接合型家族性高コレステロール血症患者におけるロミタピドの有効性と安全性
Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy.
急性覚醒時脳卒中および発症不明脳卒中に対するアルテプラーゼ0.6mg/kg投与による血栓溶解療法試験（THAWS）
The purpose of this study is to clarify efficacy and safety of MRI-based intravenous thrombolysis with alteplase for patients with acute wake-up ischemic stroke and those having acute ischemic stroke with unknown time of symptom onset.
慢性便秘患者における寒天投与が排便および便の状態に及ぼす影響
The administration of agar jelly may increase the number of defecation and the volume of feces, and then may improve fecal condition in chronic constipated patients.
肝細胞癌（HCC）患者を対象としたARQ 197の無作為化二重盲検プラセボ対照第III相臨床試験（日本）
The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic chemotherapy regimen including sorafenib.
局所進行性または転移性非小細胞肺がん患者におけるMEDI4736（デュルバルマブ）の効果を評価する国際共同研究
A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability
前向き単群多施設観察Ultimaster Desレジストリ
The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in unselected patients representing everyday clinical practice. Also the study will assess the impact of non-compliance with dual antiplatelet therapy, one month after stent implementation (frequently observed in every day clinical practice), on stent thrombosis.
日本人に対するテリパラチド療法の効果
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition. Several determinants were reported to be related to subsequent BMD increase, such as baseline bone turnover markers (BTMs), low BMD at baseline, age, prior treatment, but comprehensive discussion is lacking. Specifically, there analyses were performed fragmentarily. The main objective of this study is to reveal the determinants of subsequent BMD increase and fracture preventing effect by teriparatide. Next, in Japan, as the baby boom generation retires, aging and depopulation occur rapidly. As a result, there is a lot of nursing home. But there are few reports concerning to the efficacy of teriparatide treatment in nursing home patients. The second objective is to reveal the efficacy of teriparatide for patients living nursing home, especially BMD changes, bone turnover makers change, and adverse events.
中心網膜静脈閉塞症に伴う黄斑浮腫に対するラニビズマブ治療の予測因子
Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion (CRVO). However, there is little information on whether there are any predictive factors of treatment outcome after this treatment. We plan to perform comprehensive functional and imaging tests to determine significant predictive factors.
アリセプト使用に関する集中指導
The purpose of this study is to examine the influence of the instruction on the use of Aricept with educational brochure on the 48-week medication persistence and to assess the reasons for discontinuation.
日本人固形悪性腫瘍/中皮腫患者を対象とした、トレメリムマブ単剤療法/トレメリムマブ＋MEDI4736併用療法の安全性および忍容性を評価する第1相試験
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma
15141 固定用量補正／未治療患者および透析前患者（欧州およびアジア太平洋地域）
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin. The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease. The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests. The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research.
日本人急性心不全（AHF）患者におけるセレラキシン（Serelaxin）の安全性、忍容性および薬物動態に関する研究
This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared to placebo, when added to the standard therapy, in approximately 45 Japanese AHF patients.
進行性固形腫瘍を有する日本人被験者を対象とした、ベリパリブ単剤療法の第1相臨床試験
This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.
切除不能肝細胞癌（HCC）患者を対象としたLY2157299の臨床試験
The main purpose of this study is to evaluate safety and tolerability of LY2157299 when combined with sorafenib in Japanese hepatocellular carcinoma (HCC) participants.
HIV-1/B型肝炎重複感染成人におけるE/C/F/TAF（Genvoya®）の有効性および安全性
This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts: * Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive * Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed
日本人再発性多発性骨髄腫患者におけるアフレセルチブ単剤療法の研究
Afuresertib, an AKT inhibitor, has shown in vitro and in vivo activity in multiple myeloma models. AKT inhibitor has also demonstrated encouraging clinical activity in multiple myeloma. This study is designed to determine the tolerability, safety, pharmacokinetics and efficacy of afuresertib as monotherapy in Japanese relapsed multiple myeloma patients. This is an open label, dose-escalating, phase I study. Afuresertib will be given daily until the subjects meet any study treatment withdrawal criteria including disease progression. A total of up to 24 subjects will be enrolled in the study.
2型糖尿病の未治療患者における、セマグルチド週1回投与とプラセボの有効性および安全性の比較
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. (SUSTAIN™ 1-Monotherapy).
健康な日本人成人を対象とした、ロラゼパム単回静脈内投与の安全性および薬物動態を評価する第1相試験
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of 2-mg lorazepam intravenous administration in healthy Japanese adult subjects.