治験一覧
8,963 件中 5641〜5660 件を表示
アジア太平洋諸国におけるクロストリジウム・ディフィシル感染症の前向き観察研究
The aim of this study is to conduct an Asia-Pacific, multi-center, prospective observational study to characterize patients with CDI as well as to understand treatment and management of the disease.
エベロリムス溶出コバルトクロムステントに対する早期および後期血管反応の多施設比較
To treat patients with stable coronary artery disease, elective percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.
アルツハイマー型認知症に伴う興奮状態の治療におけるアリピプラゾール
To evaluate the efficacy (based on mean change in Cohen-Mansfield Agitation Inventory \[CMAI\] total score from baseline as the primary efficacy variable), dose-response, and safety of aripiprazole at 2, 3, and 6 mg/day in comparison with placebo in patients with agitation associated with Alzheimer's type dementia
HER2陽性転移性乳がんの一次治療におけるPF-05280014［トラスツズマブ-ファイザー］またはハーセプチン®［トラスツズマブ-EU］とパクリタキセルの併用療法に関する研究（REFLECTIONS B327-02）
The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280014 in combination with paclitaxel versus trastuzumab sourced from the European Union (trastuzumab-EU) with paclitaxel in female patients with HER2-positive, metastatic breast cancer in the first-line treatment setting. The hypothesis to be tested in this study is that the efficacy (ORR) of PF-05280014 is similar to trastuzumab-EU.
冠状動脈軌道アテレクトミーシステム研究
The purpose of the COAST clinical study data will be to utilize and to gain approval for commercializing the Micro Crown as part of the Coronary Orbital Atherectomy System (OAS).
HER2陽性早期乳がんにおけるCT-P6の有効性および安全性評価試験
This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.
高齢者を対象としたフォルシガ錠の特定臨床経験調査
The purpose of the investigation is to confirm the following under the post-marketing actual use of Forxiga Tablets (hereinafter referred to as Forxiga) in elderly patients. * 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
アインシュタイン・ジュニア：静脈血栓症の小児に対する経口リバーロキサバン
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
双極性I型うつ病患者を対象としたSM-13496の第III相臨床試験。
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.
日本人進行性黒色腫患者を対象としたイピリムマブの第2相臨床試験
The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma
脳血管および心血管腎血管イベント予防のためのフェブキソスタットに関する研究
The purpose of this study is to demonstrate the effect of febuxostat in preventing cerebral and cardiorenovascular events in elderly patients with hyperuricemia who are at risk for cerebral and cardiorenovascular disease.
健康な日本人被験者を対象としたエバセトラピブの研究
The purpose of this study is to determine if two different dosing strategies for evacetrapib will have essentially the same effect on the body. The study will also explore the effect of a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.
再発または難治性急性骨髄性白血病の日本人患者におけるASP2215の安全性、忍容性および薬物動態を調査するための用量漸増試験
The objectives of this study are to determine the safety and tolerability of ASP2215 as well as the maximum tolerated dose (MTD) based on the onset of dose limiting toxicity (DLT) and/or determine the recommended dose (RD) of ASP2215 for the next phase in subjects with relapsed or treatment-refractory acute myeloid leukemia (AML).
固形腫瘍患者を対象とした、経口投与可能な新規低分子線維芽細胞増殖因子受容体（FGFR）1、2、3および4阻害剤ASP5878の単回および複数回投与に関する非盲検第I相試験
The objectives of this study are to determine the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of oral ASP5878 in participants with solid tumors.
ミカムロBP治験への追加オプション
This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.
EGFR変異を有する固形悪性腫瘍を有する成人患者を対象とした、EGFR変異チロシンキナーゼ阻害剤EGF816の経口投与に関する第I/II相多施設共同非盲検試験
This is a Phase I/II, multi-center, open-label study, composed with a Phase I part (dose-escalation phase) followed by a Phase II part (expansion phase). The dose escalation phase was designed to determine as primary objective the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of EGF816 monotherapy in adult subjects with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC harboring specific EGFR mutations. Patients may have or not have received prior lines of antineoplastic therapy. An adaptive Bayesian Logistic Regression Model (BLRM) employing the escalation with overdose control (EWOC) principle will be used during the dose escalation part for dose level selection and MTD recommendation. The primary objective of the Phase II part is to estimate antitumor activity of EGF816 as measured by overall response rate (ORR) determined by Blinded Independent Review Committee (BIRC) assessment in accordance to RECIST 1.1.
進行固形腫瘍患者におけるABBV-399の安全性、薬物動態（PK）、および予備的有効性を評価する研究
This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.
2型糖尿病患者におけるカナグリフロジン（TA-7284）とGLP-1アナログの併用による長期安全性試験
The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.
GAPP 2調査：2型糖尿病に対するインスリン療法に関する患者と医師の世界的な意識調査
This study is conducted Asia, Europe and North America. The aim of this study is to describe insulin therapy adherence and the burden of non-adherence on patient functioning, well-being and diabetes management.
クローン病治療におけるMLN0002（300mg）の第III相試験
This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease.