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高血圧症の6歳以上16歳未満の小児患者を対象としたTAK-536の第3相長期試験

完了NCT02791438第3相

The purpose of this study is to evaluate the safety of administration of azilsartan in pediatric patients aged 6 to less than 16 years with hypertension.

対象疾患:
Pediatric Hypertension

中等度から重度の活動性クローン病患者を対象としたJNJ-64304500の安全性および有効性試験

完了NCT02877134第2相

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

対象疾患:
Crohn Disease

カプノグラフィーでモニタリングされた患者におけるオピオイド誘発性呼吸抑制の予測

完了NCT02811302該当なし

PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (RD) episodes in patients undergoing opioid therapy in the hospital ward and monitored by capnography. The score will be derived by using subjects within the derivation cohort and internally validated using subjects within the validation cohort. The primary endpoint used to derive the score will be the occurrence of RD episodes derived by Capnostream 20p device memory data combined with clinical data and validated by an independent Clinical Endpoint Committee (CEC) during the study course.

対象疾患:
Respiratory Depression

片頭痛の予防治療におけるフレマネズマブ(TEV-48125)の皮下投与の有効性と安全性

完了NCT02638103第3相

A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous (SC) administration of TEV-48125 in adult participants with chronic migraine (CM) or episodic migraine (EM). Participants with CM or EM who complete the pivotal efficacy studies of TEV-48125 (TV48125-CNS-30049 \[NCT02621931\] and TV48125-CNS-30050 \[NCT02629861\]) and agree to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), will be enrolled in this study.

対象疾患:
Migraine

双極性障害患者の認知機能に対するルラシドンの有効性に関する研究

完了NCT02731612第3相

This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression) who are in remission from an episode. Participants who show cognitive impairment at the screening visit will be enrolled into the study and randomized at the baseline visit to receive either lurasidone or placebo adjunctive therapy in a 1:1 ratio for 6 weeks.

対象疾患:
Bipolar Disorder

Ultimasterシロリムス溶出ステント留置後の3ヶ月間の二重抗血小板療法の中止

不明NCT02837003

To evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of Ultimaster sirolimus-eluting stent (U-SES). Additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.

対象疾患:
Coronary Artery Disease

非常に強力なクラスの局所コルチコステロイドの軟膏(乳剤なし)製剤に切り替えたアトピー性皮膚炎患者の治療満足度を調査する観察研究

完了NCT02627989

This study intends to investigate patient satisfaction of treatment with Ointment (W/O emulsion) formulations of Potency Class II topical corticosteroids (TCs) for atopic dermatitis (AD) patients in Japan. Objectives include measuring patient satisfaction, treatment adherence, itchiness, and AD severity scores.

対象疾患:
Dermatitis, Atopic

ADPKD患者を対象としたトルバプタンの市販後調査研究

完了NCT02847624

The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical setting in Japan.

対象疾患:
Polycystic Kidney, Autosomal Dominant

原発性胆汁性胆管炎患者の掻痒に対するナルフラフィン塩酸塩

完了NCT02659696

Nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in Japan, and in May 2015 the use of nalfurafine hydrochloride was officially approved in Japan for pruritus in patients with chronic liver diseases including PBC. In the current study, the investigators aimed to assess pruritus and overall QOL before and after administration of nalfurafine hydrochloride in patients with PBC. Furthermore, the investigators took serum sample from the enrolled patients and examine the association of pruritus with possible biomarkers.

対象疾患:
Primary Biliary Cirrhosis

中等度から重度の関節リウマチ患者におけるBMS-986142の有効性および安全性に関する研究

完了NCT02638948第2相

The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.

対象疾患:
Rheumatoid Arthritis

発作性片頭痛の予防治療におけるTEV-48125の2つの投与レジメンとプラセボの有効性および安全性

完了NCT02629861第3相

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with episodic migraine

対象疾患:
Migraine

直接作用型抗ウイルス薬を含む治療レジメンに失敗した慢性遺伝子型1型または2型C型肝炎ウイルス感染症患者を対象とした、ソホスブビル/ベルパタスビル固定用量配合剤とリバビリンの12週間または24週間の投与試験

完了NCT02822794第3相

The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.

対象疾患:
Hepatitis C Virus Infection

高血圧と不眠症を併発する患者における、スボレキサントとプラセボの睡眠圧に対する有効性の比較

完了NCT02849184第4相

The purpose of this study is to compare the effectiveness and safety of suvorexant versus placebo on sleep pressure and circadian rhythm in hypertensives with insomnia.

対象疾患:
HypertensionInsomnia

徳島ナイトガード(再発性アフタ性口内炎用)

完了NCT02890524該当なし

The investigators will investigate whether the night guard can suppress the development of recurrent aphthous stomatitis (RAS). The investigators will record the patients' oral condition for 60 days before and after intervention with the night guard made of Ethylene-Vinyl Acetate copolymer (EVA). The patients' saliva will be analyzed for measurement of inflammatory cytokines or oxidative stress.

対象疾患:
Aphthous Stomatitis

レノックス・ガストー症候群に伴う不十分な発作に対する補助療法としてのペランパネルの研究

中止NCT02834793第3相

This study is being conducted to demonstrate that perampanel given as adjunctive anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in participants with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS).

対象疾患:
Lennox-Gastaut Syndrome (LGS)

LINQレジストリを表示する

完了NCT02746471

The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.

対象疾患:
Arrhythmias, Cardiac

メトトレキサートに対する反応が不十分な中等度から重度の活動性関節リウマチの成人患者におけるフィルゴチニブとメトトレキサートの併用療法

完了NCT02889796第3相

The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.

対象疾患:
Rheumatoid Arthritis

ICDを装着した一次予防患者の評価 - ATPの系統的評価

完了NCT02923726該当なし

The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for implantable cardioverter-defibrillator (ICD) therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only to assess equivalency.

対象疾患:
Sudden Cardiac Death

追加の脳卒中または「ミニ脳卒中」の発生確率を低減するために試験されているプロテアーゼ活性化受容体4拮抗薬の安全性および有効性に関する研究

完了NCT02671461第2相

The purpose of this study is to determine whether BMS-986141 is effective in reducing the recurrence of stroke in people who recently had a stroke, or a transient ischemic attack (known as a TIA or "mini stroke") and are receiving acetylsalicylic acid (also known as aspirin or ASA) to treat the stroke or TIA.

対象疾患:
Thrombosis

XLHの小児患者におけるブロスマブと経口リン酸塩および活性型ビタミンD治療の有効性および安全性

完了NCT02915705第3相

The primary objective of this study is to evaluate the effect of KRN23 (burosumab) therapy in improving rickets in children with XLH compared with active control (oral phosphate/active vitamin D).

対象疾患:
X-Linked Hypophosphatemia