治験一覧
8,963 件中 5801〜5820 件を表示
食事療法および運動療法に加えてSYR-322 25 mgによる治療にもかかわらず血糖コントロールが不十分な2型糖尿病患者において、メトホルミン塩酸塩500 mgを1日1回SYR-322 25 mgに追加投与した場合の有効性および安全性を評価する比較試験
The purpose of this study was to evaluate the efficacy and safety of 24-week treatment with metformin hydrochloride 500 mg once daily added on to alogliptin (SYR-322) 25 mg in type 2 diabetic patients with inadequate glycemic control despite treatment with alogliptin 25 mg in addition to diet and exercise therapy.
クッシング病患者の治療におけるLCI699の安全性と有効性
The study aimed to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It was a pivotal trial which supported the registration of LCI699 for the treatment of patients with Cushing's disease in the US and the EU. This is a phase lll, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period which evaluated the safety and efficacy of LCI699 for the treatment of patients with Cushing's disease.
フォルシガ錠の長期使用に関する特定臨床経験調査
The purpose of the investigation is to confirm the following under the post-marketing actual use of Forxiga Tablets (hereinafter referred to as Forxiga) * Development of ADRs specified as Key Investigation Items and the risk factors * Contributing factors possibly having an impact on the safety and efficacy * Development of ADRs unexpected from the Precautions for use and ADRs under actual drug use
転移性結腸直腸癌における二次治療としてのRELATED±ベバシズマブとプラセボの比較に関する第III相試験。FOLFIRI±ベバシズマブ（転移性結腸直腸癌）
The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.
経口摂取は小児の術後疼痛スコアを低下させるか
Pain score after inguinal hernia repair surgery in children decreased as time passed in previous studies. Postoperative oral intake is usually resumed two hours after minor surgery in most of institutions, that may influence children's behavior and pain score. A recent study suggest that oral intake one hour after minor surgery does not increase the incidence of postoperative nausea and vomiting. The investigators primary endpoint is to clarify whether postoperative oral intake influences postoperative pain score in children.
日本における実臨床環境での2型糖尿病治療の実態を探る
This study is intended to prospectively research the treatment reality and long-term disease control of Type 2 Diabetes Mellitus (T2DM) patients who are initiating 2nd line anti-diabetes treatment in sites across Japan.
進行性または難治性の固形腫瘍またはリンパ腫患者におけるJNJ-42756493の安全性、薬物動態、および薬力学を評価する研究
The purpose of this study is to determine a dose for future development and to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy profiles of JNJ-42756493 in Japanese and other Asian patients with advanced or refractory solid tumors or lymphoma.
ラロキシフェンとバゼドキシフェンの比較
Although there are two kinds of selective estrogen receptor modulator (SERM) :raloxifene (RLX) and bazedoxifene (BZA), the difference is still unclear. In this study, we plan to compare clinical efficacy and safety between RLX and BZA.
うつ病および不安障害に対する日本統一プロトコル臨床試験（JUNP試験）
This study is to examine the superiority of the combined treatments of transdiagnostic cognitive-behavior therapy (Unified Protocol; UP) and Treatment-As-Usual in comparison with the waiting-list with Treatment-As-Usual in the reduction of depressive and anxiety symptoms among depressive and anxiety disorders.
高リスク非転移性去勢抵抗性前立腺癌男性におけるダロルタミド（ODM-201）の有効性および安全性に関する研究
The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
糖尿病性腎症患者におけるカナグリフロジンの腎臓および心血管系への影響の評価
The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).
アトピー性皮膚炎患者を対象としたデュピルマブの非盲検試験
The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.
再発性虚血性脳卒中の予防のための疾患管理プログラムの効果
It has been reported that stroke is the first cause of becoming bedridden, and its cumulative recurrence rate in 5 years is approximately 35%. There is a high probability that patients reduce or discontinue medications by self-determination, leading to a high risk of stroke recurrence in these patients. Comprehensive and long-term patient educations ameliorating their self-management are important making patients possible to be managed according to the guidelines for their risk factors. Using disease management programs created for each of risk factors according to clinical practice guidelines, the influence of those programs were evaluated for the prevention of stroke recurrence in this Disease Management Program Stroke Trial.
日本における延長試験（A2301E1）に参加した肺動脈性肺高血圧症患者にQTI571を投与するための非盲検多施設共同プロトコル
To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.
遺伝性血栓性血小板減少性紫斑病（TTP）患者におけるBAX930の安全性および薬物動態を評価するための第1相用量漸増単回投与試験
The purpose of this Phase 1, prospective, uncontrolled, open-label, multicenter, dose-escalation study is to evaluate the safety, including immunogenicity, and pharmacokinetics of BAX930 (rADAMTS13) in a total of 14 evaluable subjects diagnosed with severe hereditary thrombotic thrombocytopenic purpura (TTP) (plasma ADAMTS13 activity \<6%) who are assigned to one of three dose cohorts.
イダルシズマブによるダビガトランの抗凝固作用の逆転
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
鉄欠乏性貧血に対するZ-213の薬物動態、薬力学および安全性に関する研究
The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).
凍結乾燥生弱毒麻疹・風疹混合ワクチン（シュワルツFF-8株／TO-336株）2回目のワクチン接種後の被接種者における特定薬剤使用状況調査
The purpose of this survey is to assess the safety of freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence the safety of vaccinees after the second vaccination.
転移性胃癌または胃食道接合部癌を有する日本人患者を対象としたラムシルマブによる治療に関する研究
The purpose of this study is to evaluate progression-free survival in participants with gastric or gastroesophageal junction cancer who have had disease progression following first-line therapy who undergo treatment with ramucirumab.
Bay98-7196、用量探索／POC試験
Purpose of the study is to test efficacy and safety of BAY98-7196 intravaginal ring as a new treatment option for patients with endometriosis-associated pelvic pain