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QuQu尺度の妥当性に関する探索的研究

完了NCT02267486

Examine the construct validity, the group discriminant ability, and the inter-rater reliability of a novel dementia rating scale (QuQu scale: QUick QUestion scale) candidate for the evaluation of patients with Alzheimer Dementia (AD)

対象疾患:
Alzheimer Dementia

ドネペジル塩酸塩の市販後調査 - レビー小体型認知症(DLB)患者におけるアリセプトの長期安全性および有効性、ならびに適切な使用情報の調査。

完了NCT02448784

To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil hydrochloride in clinical practice as well as its proper use information in participants with DLB.

対象疾患:
Dementia With Lewy Body Disease

ステージIIIb/cまたはステージIVのメラノーマ完全切除後のメラノーマ再発予防におけるニボルマブとイピリムマブの有効性比較試験

完了NCT02388906第3相

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

対象疾患:
Melanoma

2型糖尿病および糖尿病性腎症患者におけるフィネレノンの有効性および安全性

完了NCT02540993第3相

The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.

対象疾患:
Chronic Kidney Disease

MT-2412の日本人2型糖尿病患者における検証的試験(カナグリフロジン併用試験)

完了NCT02354235第3相

The purpose of this study is to evaluate the efficacy and safety of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.

対象疾患:
Type 2 Diabetes Mellitus

221AD301 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NCT02477800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

ミラベグロンを服用中の過活動膀胱(OAB)患者における抗コリン薬の併用療法を評価する市販後調査。

完了NCT02294396第4相

The objective of the study was to evaluate the safety and efficacy of add-on therapy with anticholinergics in patients with OAB on mirabegron.

対象疾患:
Overactive Bladder (OAB)

完全切除された非小細胞肺癌に対する術後補助化学療法後のS-588410の研究

不明NCT02410369第2相

In this clinical study, the investigators evaluate the efficacy and safety of S-588410 in patients who underwent an adjuvant chemotherapy after the complete resection of non-small-cell lung cancer.

対象疾患:
Non-small- Cell Lung Cancer

骨髄異形成症候群患者におけるDSP-7888の研究

完了NCT02436252第1/第2相

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with MDS for whom no effective therapies currently exist.

対象疾患:
Myelodysplastic Syndrome

微量アルブミン尿を伴う日本人2型糖尿病患者におけるCS-3150の有効性および安全性を評価する研究

完了NCT02345057第2相

This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese Type 2 Diabetes Mellitus and Microalbuminuria. The Primary endpoint is the change from baseline in urinary albumin to creatine ratio (UACR).

対象疾患:
Diabetic Nephropathy

日本における新規診断多発性骨髄腫患者を対象とした、レナリドミド/デキサメタゾン併用療法(エロツズマブ併用または非併用)の第II相試験

完了NCT02272803第2相

The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan.

対象疾患:
Multiple Myeloma

低CA125プラチナ感受性卵巣がん患者を対象とした、ファルレツズマブ(MORAb 003)とカルボプラチン+パクリタキセルまたはカルボプラチン+ペグ化リポソームドキソルビシン(PLD)の併用療法の有効性および安全性を評価する研究

完了NCT02289950第2相

MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in subjects with low cancer antigen 125 (CA125) platinum-sensitive ovarian cancer in first relapse.

対象疾患:
Platinum-Sensitive Ovarian Cancer in First Relapse

自然早産の女性を対象とした、静脈内投与レトシバンとプラセボの有効性および安全性に関する第III相試験

中止NCT02377466第3相

The study's primary objective is to demonstrate the superiority of retosiban to prolong pregnancy and improve neonatal outcomes compared with placebo. It is a Phase III, randomized, double-blind, parallel-group, multicenter study and will be conducted in approximately 900 females, aged 12 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes in preterm labor between 24\^0/7 and 33\^6/7 weeks of gestation. Eligible maternal subjects will be randomly assigned in a 1:1 ratio to receive either retosiban IV infusion or placebo IV infusion over 48 hours. If not previously administered, antenatal corticosteroid treatment should be administered as either (1) two 12-mg doses of betamethasone given intramuscularly 24 hours apart or (2) four 6-mg doses of betamethasone administered intramuscularly every 12 hours. A single rescue course of antenatal corticosteroids is permitted if the antecedent treatment was at least 7 days prior to study enrolment. Investigators have discretion to use a standardized regimen of magnesium sulphate, as well as intrapartum antibiotic prophylaxis for perinatal group B streptococcal infection. Prior to randomization, each subject will be stratified by progesterone treatment and gestational age. The progesterone strata will consist of subjects on established progesterone therapy or subjects not on established progesterone therapy at Screening. The study will comprise 6 phases: Screening, Inpatient Randomized Treatment, Post Infusion Assessment, Delivery, Maternal Post-Delivery Assessment, and Neonatal Medical Review. The duration of any subject's (maternal or neonatal) participation in the study will be variable and dependent on gestational ages (GA) at study entry and the date of delivery.

対象疾患:
Obstetric Labour, Premature

痛風または無症候性高尿酸血症患者の治療における、フェブキソスタットとの併用によるRDEA3170の薬力学/安全性試験

完了NCT02317861第1/第2相

The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of multiple doses of RDEA3170 administered in combination with febuxostat compared to RDEA3170 administered alone and febuxostat administered alone in Japanese adult male subjects with gout or asymptomatic hyperuricemia.

対象疾患:
Gout and Asymptomatic Hyperuricemia

頭頸部がん治療におけるパルボシクリブ+セツキシマブ併用療法とセツキシマブ単剤療法の安全性および有効性に関する研究

完了NCT02499120第2相

The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and neck.

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

中等度から重度の慢性閉塞性肺疾患(COPD)患者を対象とした、PT010のPT003およびPT009に対する有効性および安全性を評価する研究(Ethos社)

完了NCT02465567第3相

This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.

対象疾患:
COPD

治療歴のない慢性リンパ性白血病/小リンパ球性リンパ腫患者を対象とした、ブルトン型チロシンキナーゼ(BTK)阻害剤イブルチニブの研究

完了NCT02556892第1相

The purpose of this study is to evaluate the safety of Ibrutinib in Japanese participants with treatment-naive chronic lymphocytic leukemia ( CLL) or small lymphocytic lymphoma (SLL).

対象疾患:
Lymphocytic Leukemia

安定した抗精神病薬治療を受けている統合失調症患者を対象に、4種類の異なる用量のBI 409306をプラセボと比較して12週間投与した場合の有効性、安全性、忍容性を調査する研究。

完了NCT02281773第2相

The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.

対象疾患:
Schizophrenia

二塩化ラジウム223長期追跡調査プログラム

完了NCT02312960第4相

Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo.

対象疾患:
Neoplasm Metastasis / Bone and Bones

ELUVIA™ 薬剤溶出ステントと Zilver® PTX® ステントの比較

完了NCT02574481該当なし

The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length. Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.

対象疾患:
Atherosclerosis of Native Arteries of the Extremities