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心房細動患者におけるカテーテルを用いた心臓弁置換術後のエドキサバンと標準治療の比較(ENVISAGE-TAVI AF)

完了NCT02943785第3相

When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation. Atrial fibrillation goes along with blood clots that may cause mainly strokes and less often other diseases, such as a heart attack. Some patients with atrial fibrillation have other heart disease, such as heart valves that may need to be replaced using catheters. Often doctors give patients drugs that reduce those blood clots. These are either vitamin K antagonist (VKA) or direct anticoagulants, such as edoxaban. In these patients, it is unclear which of the drugs is better for reducing stroke without increasing severe bleedings.

対象疾患:
Atrial Fibrillation

世界非介入型心不全疾患登録

中止NCT02595814

The clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF disease registry designed to characterize patient trajectories longitudinally during and following an index hospitalization for acute HF.

対象疾患:
Acute Heart Failure

日本人2型糖尿病患者におけるインスリングラルギン/リキシセナチド固定比率配合剤の食後血糖動態反応

完了NCT02713477第1相

Primary Objective: To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM). Secondary Objectives: * To assess the pharmacokinetics (PK) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM. * To assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in Japanese patients with T2DM. * To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.

対象疾患:
Type 2 Diabetes Mellitus

BRAF V600変異陽性の低悪性度神経膠腫または再発性もしくは難治性の高悪性度神経膠腫を有する小児患者における、ダブラフェニブとトラメチニブの併用療法の有効性および安全性に関する研究

完了NCT02684058第2相

The purpose of this study was to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma (LGG) or relapsed or refractory high grade glioma (HGG)

対象疾患:
Anaplastic AstrocytomaAnaplastic GangliogliomaAnaplastic OligodendrogliomaAnaplastic Pleomorphic XanthoastrocytomaAngiocentric Glioma17

アトピー性皮膚炎患者におけるOPA-15406軟膏の有効性に関する研究

完了NCT02914548第2相

The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in patients with atopic dermatitis.

対象疾患:
Atopic Dermatitis

2型糖尿病およびアルブミン尿を伴う高血圧患者におけるCS-3150の研究

完了NCT02807974第3相

To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.

対象疾患:
Hypertension

切除不能胸膜中皮腫患者に対する第一選択療法として、ニボルマブとイピリムマブの併用療法とペメトレキセドとシスプラチンまたはカルボプラチンの併用療法を比較した研究

完了NCT02899299第3相

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

対象疾患:
Mesothelioma

健康な被験者および軽度認知障害またはアルツハイマー病(AD)患者を対象としたLY2599666の研究

中止NCT02614131第1相

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY2599666 in different groups of people - those who are healthy, those who have mild cognitive impairment due to Alzheimer's Disease (AD), and those with mild-to-moderate AD. The study will measure how much LY2599666 gets into the bloodstream and how long it takes the body to get rid of it. It will also evaluate how LY2599666 affects the body. The study has three parts. Part A will last about 2 months. Parts B and C will each last about 23 weeks. Participants may only enroll in one part.

対象疾患:
Alzheimer's DiseaseHealthyMild Cognitive Impairment

健康な成人被験者を対象としたTAK-850皮下注射の第2相試験

取り下げNCT02713061第2相

This clinical trial is a Phase 2 study of a single subcutaneous injection of TAK-850 for 22 days in healthy Japanese adults.

対象疾患:
Influenza Prevention

ST上昇型心筋梗塞患者におけるエベロリムス溶出コバルトクロムステント留置後の超早期および後期臨床転帰に関する多施設共同レジストリ

不明NCT02792920該当なし

To compare early and late clinical outcomes with everolimus-eluting cobalt-chromium stent in patients with ST-elevation acute myocardial infarction, as well as identify the characteristics and efficacy of CoCr-EES. Also, OCT sub-analysis will be conducted

対象疾患:
ST-elevation Acute Myocardial InfarctionSTEMI

前駆期アルツハイマー病患者を対象としたソラネズマブ(LY2062430)の研究

中止NCT02760602第3相

The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).

対象疾患:
Alzheimer's Disease

貧血を伴う赤血球生成刺激剤(ESA)未投与の血液透析慢性腎臓病患者におけるASP1517の間欠的経口投与に関する研究

完了NCT02780141第3相

The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive hemodialysis chronic kidney disease patients with anemia.

対象疾患:
ESA-naive Hemodialysis Chronic Kidney Disease Patients With Anemia

胃がんの一次維持療法におけるアベルマブ(JAVELIN Gastric 100)

完了NCT02625610第3相

The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.

対象疾患:
Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction

喘息患者におけるQMF149(150/80 µg)とMFツイストヘラー®(200 µg)の比較試験

完了NCT02892344第3相

The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d. delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.

対象疾患:
Mild Asthma

転移性ホルモン感受性前立腺癌(mHSPC)患者におけるエンザルタミド+アンドロゲン除去療法(ADT)とプラセボ+ADTの併用療法の比較試験

完了NCT02677896第3相

The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.

対象疾患:
Metastatic Hormone Sensitive Prostate Cancer

シリコーンハイドロゲル製1日使い捨てトーリックレンズ「ステンフィルコンA」の臨床研究

完了NCT02801006該当なし

The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.

対象疾患:
Astigmatism

上皮性卵巣がんの未治療患者におけるアベルマブ(JAVELIN OVARIAN 100)

中止NCT02718417第3相

This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy. The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.

対象疾患:
Ovarian Cancer

未治療の進行期小細胞肺癌(ES期)患者を対象とした、カルボプラチンとエトポシド併用療法(アテゾリズマブ併用または非併用)に関する研究

完了NCT02763579第3相

This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

対象疾患:
Small Cell Lung Carcinoma

局所進行性頭頸部扁平上皮癌患者における根治的治療として、アベルマブと標準治療化学放射線療法(SoC CRT)の併用療法とSoC CRT単独療法を比較する研究(JAVELIN HEAD AND NECK 100)

中止NCT02952586第3相

This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

対象疾患:
Squamous Cell Carcinoma of the Head and Neck

関節リウマチにおけるLY3337641の研究

中止NCT02628028第2相

The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in adults with rheumatoid arthritis (RA).

対象疾患:
Rheumatoid Arthritis