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進行性固形腫瘍に対する一次化学療法とのデュルバルマブおよびトレメリムマブの併用療法

完了NCT02658214第1相

Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ cancer, PDAC, ESCC.

対象疾患:
Carcinoma, Pancreatic DuctalCarcinoma, Squamous Cell of Head and NeckEsophageal Squamous Cell CarcinomaEsophagogastric Junction NeoplasmsFallopian Tube Neoplasms5

難治性、局所進行性または転移性固形腫瘍を有する日本人被験者を対象としたBAY 1163877(ロガラチニブ)の第I相用量漸増試験

完了NCT02592785第1相

Primary objectives of this study are to assess the safety and tolerability of BAY 1163877 in Japanese subjects with refractory, locally advanced or metastatic solid tumors and to characterize the PK of BAY 1163877

対象疾患:
Neoplasms

難治性高血圧における超音波による24時間血圧コントロールの質に対する腎神経切除の影響

完了NCT02918305第3相

The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc. Paradise in Europe) for renal denervation therapy in patients with treatment resistance hypertension, in comparison with the sham procedure.

対象疾患:
HypertensionVascular Diseases

成長ホルモン治療未経験の思春期前成長ホルモン欠乏症小児における週1回投与のNNC0195-0092療法と毎日投与の成長ホルモン療法(ノルディトロピン®フレックスプロ®)の有効性と安全性の比較

完了NCT02616562第2相

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency. The main trial period will consist of 26 weeks of treatment, followed by a 26 week extension period.

対象疾患:
Growth Hormone Deficiency in ChildrenGrowth Hormone Disorder

慢性腎臓病(CKD)を伴う腎性貧血患者を対象としたJR-131の第III相臨床試験

完了NCT02912494第3相

The purpose of this study is to investigate the equivalence of JR-131 to Darbepoetin alfa and evaluate the safety of JR-131 in renal anemia patients with chronic kidney disease (CKD).

対象疾患:
Anemia

コントロール不良の喘息を有する成人および青年におけるトラロキヌマブの安全性を評価する研究

中止NCT02902809第3相

A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus Long-Acting β2-Agonist

対象疾患:
Inadequately Controlled Asthma

転移性または局所進行性固形腫瘍を有する参加者におけるMSB0011359C(M7824)

完了NCT02699515第1相

The main purpose of this study was to assess the safety and tolerability of MSB0011359C. Study consists of dose-escalation part and an expansion part in participants with metastatic or locally advanced solid tumors, for which no standard effective therapy exists or a standard therapy had failed.

対象疾患:
Solid Tumors

糖尿病性腎症患者におけるMT-3995の長期治療試験

完了NCT02676401第2相

This study aims to evaluate the safety and efficacy of MT-3995 administered over the longer term, following MT-3995-J05 study.

対象疾患:
Diabetic Nephropathy

再発性および/または難治性固形腫瘍および非ホジキンリンパ腫患者を対象としたCC-90011の安全性および有効性試験

中止NCT02875223第1相

Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with advanced unresectable solid tumors (enriched for grade 2 NENs, grade 2 NETs and NECs) and R/R NHL (MZL, including extranodal MZL \[EMZL\], splenic MZL \[SMZL\], nodal MZL \[NMZL\], and histologic transformation of MZL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90011 administered at or below the MTD in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the RP2D.

対象疾患:
Lymphoma, Non-HodgkinNeoplasms

日本人1型糖尿病患者におけるインスリンへのエンパ併用療法

完了NCT02702011第2相

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive therapy to insulin.

対象疾患:
Diabetes Mellitus, Type 1

進行性悪性腫瘍およびリンパ腫患者を対象とした、GWN323単剤療法およびPDR001との併用療法に関する第I/Ib相試験

完了NCT02740270第1相

The purpose of this trial is to explore the clinical utility of two investigational antibodies in patients with advanced cancer or lymphomas. This is a multi-center, open-label Phase I/Ib study. The study consists of two dose escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test different dosing schedules. The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer and lymphomas. Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.

対象疾患:
LymphomasSolid Tumors

クイザルチニブの第1相試験

完了NCT02675478第1相

This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for Japanese acute myeloid leukemia (AML) subjects.

対象疾患:
Refractory AMLRelapsed AML

前駆期から軽度アルツハイマー病(AD)患者を対象とした、クレネズマブとプラセボの有効性および安全性を評価する研究。

中止NCT02670083第3相

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.

対象疾患:
Alzheimer's Disease

タグリッソ錠の臨床経験調査(全症例調査)

完了NCT02756039

Clinical experience investigation (CEI) is to be conducted to confirm the following to characterise safety and efficacy of Tagrisso Tablets in actual clinical use. 1. Incidence of adverse drug reactions (ADRs) in actual clinical use 2. Factors which may affect safety and efficacy of the product (especially analysis of the incidence and risk factors of interstitial lung disease (ILD) events) 3. Information of ADRs not expected from "Precautions for Use" of the package insert in Japan

対象疾患:
All Patients Treated With the Product

日本人女性における夜間多尿による夜間頻尿に対するデスモプレシン口腔内崩壊錠(ODT)の臨床試験

完了NCT02905682第3相

The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of female subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.

対象疾患:
Nocturia

喘息のコントロール、生活の質、そして実生活における感情面への影響

完了NCT02640742

This study aims to evaluate the asthma control status, asthma symptoms (severity, frequency, and limitations on activities, etc.), QOL, and use of drugs for asthma attack in adult asthma patients.

対象疾患:
Asthma

不眠症に対するレンボレキサントの長期研究(SUNRISE 2)

完了NCT02952820第3相

The key objectives of this study are to determine, using sleep diaries, whether lemborexant at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset, subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia disorder.

対象疾患:
Insomnia Disorder

インスリン療法を受けている2型糖尿病患者におけるイプラグリフロジンの研究

完了NCT02847091第4相

The objective of this study is to assess the reduction in insulin dose from baseline at Week 24 while keeping the blood glucose levels controlled (maintaining HbA1c values) when ipragliflozin is administered once daily for 24 weeks in patients with type 2 diabetes mellitus receiving insulin therapy.

対象疾患:
Type 2 Diabetes Mellitus

80歳以上の高齢者を対象としたDU-176bの研究

完了NCT02801669第3相

The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with non-valvular NVAF aged 80 years or older who are ineligible for available oral anticoagulation therapy.

対象疾患:
Atrial Fibrillation

PRESSUREwire 研究

完了NCT02935088

The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

対象疾患:
Acute Coronary SyndromeCoronary Artery Disease