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2型糖尿病および慢性腎臓病患者におけるダパグリフロジン単独投与およびサキサグリプチン併用投与のアルブミン尿への影響を評価し、ダパグリフロジンとサキサグリプチンの併用投与がHbA1cに及ぼす影響を調査する研究

完了NCT02547935第2/第3相

The purpose of this clinical research study is to determine whether dapagliflozin alone or in combination with saxagliptin can decrease albuminuria and improve glycemic control in patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned to randomize a total of 450 patients (150 patients per treatment arm)

対象疾患:
Type 2 Diabetes Mellitus, CKD and Albuminuria

重度から非常に重度の慢性閉塞性肺疾患患者における中等度から重度の増悪を軽減する上でのチオトロピウム+オロダテロール(5/5 µg)固定用量配合剤(FDC)とチオトロピウム5µgの有効性の比較。

完了NCT02296138第3相

The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

対象疾患:
Pulmonary Disease, Chronic Obstructive

成長ホルモン欠乏症で過去にヒト成長ホルモン治療を受けた成人を対象に、ソマパシタンの週1回投与とノルディトロピン®フレックスプロ®の毎日投与の安全性を26週間比較する試験

完了NCT02382939第3相

This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in previously human growth hormone (hGH) treated adults with growth hormone deficiency.

対象疾患:
Adult Growth Hormone DeficiencyGrowth Hormone Disorder

アジア人の皮膚における肝斑および老人性色素斑の治療にレーザーを使用する前向き多施設共同研究

完了NCT02385994該当なし

The purpose of this investigation is to evaluate safety and efficacy of the Cutera enlighten dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser for the treatment of melasma and lentigines on the face in Asian skin.

対象疾患:
LentiginesMelasma

XIENCE PRIME SV エベロリムス溶出型冠動脈ステントの日本における市販後調査(XIENCE PRIME SV Japan PMS)

完了NCT02513719

The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals.

対象疾患:
Angina PectorisCoronary Artery DiseaseCoronary Artery OcclusionIschemic Heart DiseaseMyocardial Ischemia

ステージIVの非扁平上皮または扁平上皮非小細胞肺癌(NSCLC)患者を対象とした、アテゾリズマブ(MPDL3280A)とプラチナ製剤(シスプラチンまたはカルボプラチン)+(ペメトレキセドまたはゲムシタビン)との比較研究 [IMpower110]

完了NCT02409342第3相

This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.

対象疾患:
Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer

オメガ3脂肪酸エチルエステル顆粒カプセル製剤の特定医薬品使用調査:OCEAN3

完了NCT02285166

The purpose of this survey is to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with and without omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in high-risk hyperlipidemic patients treated by statin in daily medical practice.

対象疾患:
Hyperlipidemia

日本人2型糖尿病患者におけるジャディアンス®錠の長期連日使用

完了NCT02489942

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

対象疾患:
Diabetes Mellitus, Type 2

肝機能障害患者における薬物動態学的研究

完了NCT02586194第1相

The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in patients with impaired hepatic function and subjects with normal hepatic function.

対象疾患:
Patients With Impaired Hepatic Function

企業主催の治験に以前参加し、治験治療を受けている固形腫瘍患者を対象としたオナルツズマブの延長試験

完了NCT02488330第3相

This extension study will provide continued onartuzumab and/or parent trial (P-trial) designated control treatments to participants with cancer who were previously enrolled in a company-sponsored onartuzumab P-trial and who derived benefit, as assessed by the responsible investigator, from the therapy administered in the P-trial. The study will also collect safety data with regard to administration of continued onartuzumab therapy.

対象疾患:
Solid Tumor

221AD302 早期アルツハイマー病患者を対象としたアデュカヌマブ(BIIB037)の第3相臨床試験

中止NCT02484547第3相

The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) \[ADAS-Cog 13\], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) \[ADCS-ADL-MCI\].

対象疾患:
Alzheimer's Disease

再発性去勢抵抗性前立腺癌患者を対象としたGEN0101の第1相試験

不明NCT02502994第1相

This study is designed to evaluate the safety and efficacy of a single injection of GEN0101 in patients with recurrence of castration resistant prostate cancer. The subjects receive GEN0101 injection 4 times per two weeks (1st intratumoral injection and followed subcutaneous injection) and two weeks of observation as one cycle treatment period. Each subject receive two cycle treatment period. Low dose group: 30,000m NAU per injection of GEN0101 High dose group: 60,000m NAU per injection of GEN0101 Each group included minimal 3 subjects.

対象疾患:
Castration Resistant Prostate Cancer

グリアデルウェハーの長期観察に関する市販後調査―高悪性度神経膠腫患者の生命予後に関する調査

完了NCT02300506

The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).

対象疾患:
Malignant Glioma

局所進行性または転移性非小細胞肺癌患者における、PD-L1発現に基づいて決定される単剤療法またはトレメリムマブとの併用療法としてのMEDI4736(デュルバルマブ)の効果を標準治療と比較評価する国際共同研究

完了NCT02352948第3相

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib \[TARCEVA®\]), gemcitabine or vinorelbine (NAVELBINE®)

対象疾患:
Non - Small Cell Lung Cancer NSCLC

シェーグレン症候群を伴うドライアイ患者を対象としたKCT-0809の第III相臨床試験

完了NCT02503189第3相

The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome

対象疾患:
Dry Eye With Sjögren's Syndrome

進行性または転移性軟部肉腫患者を対象としたドキソルビシンとオララツマブ(LY3012207)の併用療法に関する研究

完了NCT02451943第3相

The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.

対象疾患:
Soft Tissue Sarcoma

小児におけるメポリズマブの皮下投与時の薬物動態および薬力学

完了NCT02377427第2相

Mepolizumab is a humanized immunoglobulin G (IgG1) monoclonal antibody (mAb) that exhibits dose proportional and time-independent pharmacokinetics. The study will be conducted in 2 parts. Part A: it will be pharmacokinetic (PK) and pharmacodynamic (PD) study conducted to support the use of mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma and characterize the PK/PD of mepolizumab 40 milligrams (mg) or 100 mg administered subcutaneously depending on participant body weight. Part B: It is a long-term safety / pharmacodynamic phase in which extended treatment for a further 52 weeks will be offered on an optional basis to those subjects eligible for continued treatment. Participants with bodyweight \<40 kilogram (kg) will be dosed with mepolizumab 40 mg and participants with body weight \>=40 kg will be dosed with mepolizumab 100 mg subcutaneously in upper arm or thigh at Visit 2 (Week 0). Approximately 40 male or female participants aged 6 to 11 years will be screened to achieve approximately 28 eligible participants entering the treatment phase to allow availability of 20 evaluable participants, with a minimum of six participants enrolled in the \<40 kg bodyweight group. The total duration of the study will be 22 weeks and will include a run-in period of 1-2 weeks, a treatment period of 12 weeks and a follow-up phase of 8 weeks. A participant will be considered having completed the study if the participant completes all phases of the study including the follow-up phase (Week 20 \[visit 8\]).

対象疾患:
Asthma

2型糖尿病患者における、基礎インスリン単独療法または基礎インスリンとメトホルミンの併用療法への追加療法としてのセマグルチド週1回投与とプラセボの有効性および安全性

完了NCT02305381第3相

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes.

対象疾患:
DiabetesDiabetes Mellitus, Type 2

ノバルティスがスポンサーとなった研究でセリチニブ治療を受けている患者にセルチニブ(LDK378)へのアクセスを許可するロールオーバー研究

実施中(募集終了)NCT02584933第4相

ロールオーバー試験では、ノバルティスがスポンサーとなっている試験で現在セリチニブによる治療を受けており、治験責任医師の意見ではセリチニブによる治療継続が有益であると判断された患者にセリチニブが提供されます。

対象疾患:
ALK陽性悪性腫瘍

バイオクリーンMPS(多目的溶液)VIIとバイオフィニティレンズの併用:2週間のクロスオーバー試験

完了NCT02537730該当なし

Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).

対象疾患:
Myopia