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2型糖尿病における進行性左室拡張機能障害に対するテネリグリプチンの効果に関する研究

不明NCT02449330第4相

This is the clinical trial designed to assess the cardiac diastolic function of long term treatment with teneligliptin compared to that without teneligliptin in patients with type 2 diabetes mellitus by two arms; one includes patients showing E/e' by echocardiography less than 8, the other includes patients showing E/e' by echocardiography more than 8.

対象疾患:
Diabetes Mellitus, Type 2

AZORGA®点眼懸濁液とCOSOPT®点眼液の眼圧(IOP)降下効果と安全性の比較

完了NCT02325518第4相

The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.

対象疾患:
Ocular HypertensionOpen-Angle Glaucoma

非小細胞肺癌患者におけるアベルマブとクリゾチニブまたはPF-06463922の併用療法の安全性、有効性、薬物動態および薬力学を評価する研究。(Javelin Lung 101)

中止NCT02584634第1/第2相

The purpose of this study is to evaluate the safety and efficacy of avelumab when combined with either crizotinib or PF-06463922.

対象疾患:
Non-Small Cell Lung Cancer

日本におけるダコミチニブの継続投与プロトコル

完了NCT02382796第2相

The purpose of this study to permit continued access to dacomitinib for patients who participated in other dacomitinib monotherapy treatment protocols in Japan and have the potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib treatment.

対象疾患:
NSCLC

グリアデル7.7mgインプラントの市販後調査(全症例観察研究)

完了NCT02300532

Post-marketing surveillance to investigate the clinical safety and effectiveness in patients of all implantation of Gliadel with malignant glioma in the actual medical setting.

対象疾患:
Malignant Glioma

局所進行性または転移性尿路上皮膀胱癌患者を対象としたアテゾリズマブと化学療法の比較研究 [IMvigor211]

完了NCT02302807第3相

This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.

対象疾患:
Bladder Cancer

日本人健康成人を対象とした、植物ステロール強化発酵乳製品の安全性評価に関する臨床試験

完了NCT02278393該当なし

Investigate the safety of excessive consumption of plant sterol-enriched fermented dairy product over a 4-week period in Japanese healthy adults

対象疾患:
Healthy Volunteers

切除可能な直腸癌患者を対象としたSOX療法とmFOLFOX6療法の比較に関するRP II試験(KSCC1301)。

不明NCT02280070第2相

To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer, and to identify the more promising regimen.

対象疾患:
Rectal Cancer

日本人高齢2型糖尿病患者におけるジャディアンス®錠の毎日服用

完了NCT02367131

Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.

対象疾患:
Diabetes Mellitus, Type 2

中等度から重度の尋常性乾癬患者を対象としたイキセキズマブ(LY2439821)の異なる投与レジメンを比較する研究

完了NCT02513550第3相

The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.

対象疾患:
Plaque Psoriasis

未治療の転移性トリプルネガティブ乳がん患者を対象とした、アテゾリズマブとナブパクリタキセルの併用療法とプラセボとナブパクリタキセルの併用療法を比較した研究(IMpassion130)

完了NCT02425891第3相

This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.

対象疾患:
Triple Negative Breast Cancer

新規診断された急性骨髄性白血病患者を対象とした、ウロクプルマブと低用量シタラビンの併用による免疫療法に関する治験研究

中止NCT02305563第1/第2相

The purpose of this study is to determine the safety and effectiveness of ulocuplumab in combination with low dose cytarabine in the treatment of Newly Diagnosed Acute Myeloid Leukemia (AML).

対象疾患:
Leukemia

非小細胞肺がんの一次治療におけるアベルマブ(JAVELIN Lung 100)

完了NCT02576574第3相

The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.

対象疾患:
First Line Non-Small Cell Lung Cancer

進行性肝細胞癌の成人患者におけるBBI608とソラフェニブの併用投与に関する研究

完了NCT02358395第1相

This is an open-label, multicenter, phase 1 study of BBI608 in combination with Sorafenib. This study population is adult Japanese patients with advanced hepatocellular carcinoma in Sorafenib combination therapy.

対象疾患:
Hepatocellular Carcinoma

新生血管性加齢黄斑変性症に対するラニビズマブを用いた治療延長療法の有用性の評価。

完了NCT02321839第4相

To evaluate the visual outcome, number of injections and visits, and the effect of mental status of a treat and extend regimen in managing neovascular age-related macular degeneration with intravitreal ranibizumab.

対象疾患:
Neovascular Age-related Macular Degeneration

糖尿病性腎症患者におけるMT-3995の有効性と安全性

完了NCT02517320第2相

The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the first morning void urine sample as an indicator.

対象疾患:
Diabetic Nephropathy

統合失調症患者におけるDSP-5423Pの確認試験

完了NCT02287584第3相

The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.

対象疾患:
Schizophrenia

レボセチリジンの第1相試験

完了NCT02447393第1相

This is a single center, single blind, single dose, randomized, partial cross-over study to confirm bioequivalence between levocetirizine and cetirizine.

対象疾患:
Dermatitis

ホルモン受容体陽性、HER2陰性の進行乳がんを有する閉経前(ゴセレリン併用)および閉経後女性を対象とした、LEE011とレトロゾールの併用療法の第Ib相用量漸増試験およびLEE011とホルモン療法の併用療法の用量拡大試験

完了NCT02333370第1相

The purpose of the Phase Ib is to: 1. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in Asian non-Japanese patients 2. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and activity data in Japanese patients 3. evaluate the safety and anti-tumor activity of LEE011 at the RP2D established in the dose escalation part in combination with a standard dose of letrozole, fulvestrant or tamoxifen plus goserelin in Japanese patients.

対象疾患:
Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

切除可能境界域膵臓がん患者に対する術前化学療法の第I相試験。

不明NCT02506803第1相

Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen.

対象疾患:
Pancreatic Cancer