🏥 治験ポータル

治験一覧

8,963 件中 35613580 件を表示

急性冠症候群患者を対象とした、二重抗血小板療法の短期および最適期間に関する第2相試験

実施中(募集終了)NCT03462498第4相

The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES) under the setting of acute coronary syndrome (ACS).

対象疾患:
Acute Coronary SyndromeAcute Myocardial InfarctionCoronary Artery DiseasePercutaneous Coronary InterventionPlatelet Aggregation Inhibitors

中等度から重度のアトピー性皮膚炎を有する12歳以上の被験者におけるPF-04965842の有効性および安全性を評価する研究

完了NCT03575871第3相

B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

対象疾患:
Dermatitis, Atopic

再発卵巣がん患者を対象としたニラパリブ(維持療法)の日本における第2相臨床試験

完了NCT03759587第2相

The purpose of this study is to evaluate the safety and efficacy of niraparib in Japanese participants with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who achieved complete response (CR) or partial response (PR) in the last chemotherapy containing platinum-based anticancer agents.

対象疾患:
Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cancer

再発性および/または難治性固形癌の成人患者におけるABBV-155単独およびタキサン療法との併用療法の試験

完了NCT03595059第1相

An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-155 alone and in combination with paclitaxel or docetaxel. In Part 1 (dose escalation), participants will receive escalating doses of ABBV-155 monotherapy (Part 1a) or ABBV-155 in combination with paclitaxel or docetaxel (Part 1b). In Part 2 (dose expansion), participants will receive ABBV-155 monotherapy or in combination therapy. The ABBV-155 monotherapy cohort will enroll participants with relapsed or refractory (R/R) small cell lung cancer (SCLC) (Part 2a); the ABBV-155 plus a taxane (paclitaxel or docetaxel) combination cohort will enroll participants with R/R non-small cell lung cancer (NSCLC) and breast cancer (Part 2b).

対象疾患:
Advanced Solid Tumors

日本人てんかん患者を対象とした静脈内投与ペランパネルの研究

完了NCT03754582第2相

The purpose of the study is to evaluate the safety and tolerability of perampanel administered as a 30-minute intravenous infusion after switching from oral tablets (8 to 12 milligrams per day \[mg/day\]) as an adjunctive therapy in participants with epilepsy with partial onset seizures (POS) (including secondarily generalized seizures) or primary generalized tonic-clonic (PGTC) seizures.

対象疾患:
EpilepsySeizures

OCTを用いてアリロクマブの新規アテローム性動脈硬化症に対する有効性を、標準的なスタチン療法と比較して評価する。

不明NCT03533959

The aim of this study is to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis by using optical coherence tomography, in comparison with standard statin therapy.

対象疾患:
Coronary Artery Disease Progression

相同組換え修復変異(HRRm)または相同組換え欠損(HRD)陽性の既治療進行癌患者におけるオラパリブ(MK-7339)の有効性と安全性(MK-7339-002 / LYNK-002)

実施中(募集終了)NCT03742895第2相

This study will evaluate the efficacy and safety of olaparib (MK-7339) monotherapy in participants with multiple types of advanced cancer (unresectable and/or metastatic) that: 1) have progressed or been intolerant to standard of care therapy; and 2) are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD).

対象疾患:
進行性固形腫瘍

FYU-981とオキサプロジンの薬物相互作用に関する研究

完了NCT03350386第1相

This is an open-label, 2-period add-on study to assess the drug-drug interaction between FYU-981 and oxaprozin. The purpose of this study is to investigate the pharmacokinetics of each period in a single administration of FYU-981 and concomitant administration of FYU-981 with oxaprozin at steady -state in healthy volunteers.

対象疾患:
Healthy

バイオトロニック社製CRTデバイスを植え込んだ心不全患者の臨床日常ケアの観察

実施中(募集終了)NCT03366545

The registry is primarily designed to assess outcome, efficacy and residual safety aspects of CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the observation of the patient status should help to find possible predictors for HF events and to identify areas of improvement for CRT and for CRT device settings.

対象疾患:
心不全

トラロキヌマブの過去の試験に参加したアトピー性皮膚炎患者を対象とした長期継続試験 - ECZTEND

完了NCT03587805第3相

The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.

対象疾患:
Atopic Dermatitis

アログリプチンとメトホルミン塩酸塩配合錠の特定薬剤使用調査「腎機能障害、肝機能障害、または高齢の2型糖尿病患者における長期使用に関する調査」

完了NCT03555565

The purpose of this survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) in the routine clinical setting.

対象疾患:
Type 2 Diabetes Mellitus

LEO 90100フォームの皮膚薬物動態試験

完了NCT03476746第1相

This is a phase 1, single centre trial in Japanese healthy male subjects comparing the amount of active ingredients of LEO 90100 foam and Dovobet® ointment in the stratum corneum.

対象疾患:
Healthy

中等度から重度の慢性尋常性乾癬の成人被験者におけるビメキズマブの有効性と安全性をプラセボおよび実薬対照と比較評価する試験

完了NCT03370133第3相

This is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).

対象疾患:
Chronic Plaque PsoriasisModerate to Severe Chronic Plaque PsoriasisPsoriatic Arthritis

FYU-981(最終製剤)の臨床薬理

完了NCT03350373第1相

This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.

対象疾患:
Healthy

健康な成人被験者を対象としたBLB-750の筋肉内注射に関する第4相市販後調査

完了NCT03370289第4相

The purpose of this study is to evaluate the immunogenicity and safety of two intramuscular vaccinations with BLB-750 in healthy Japanese adults.

対象疾患:
Pandemic Influenza Prevention

進行性トリプルネガティブ乳がん患者におけるLAG525とスパルタリズマブ、またはスパルタリズマブとカルボプラチン、またはカルボプラチンとの併用療法の有効性および安全性に関する研究

完了NCT03499899第2相

The main purpose of this study was to assess the antitumor activity of three combinations: i) LAG525 + spartalizumab; ii) LAG525 + spartalizumab + carboplatin, and iii) LAG525 + carboplatin in participants with advanced triple-negative breast cancer (TNBC) in first or second line therapy.

対象疾患:
Triple-negative Breast Cancer

肝切除またはアブレーション後の再発リスクが高い肝細胞癌患者を対象としたニボルマブの試験

実施中(募集終了)NCT03383458第3相

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

対象疾患:
Hepatocellular CarcinomaLiver Cancer

日本における慢性腎臓病に伴う貧血を有する腹膜透析患者を対象としたMT-6548の有効性および安全性を評価する試験

完了NCT03402386第3相

To evaluate the efficacy and safety of MT-6548 in peritoneal dialysis subjects with anemia associated with chronic kidney disease

対象疾患:
Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease

糖尿病性黄斑浮腫による視覚障害患者におけるブロルシズマブとアフリベルセプトの有効性および安全性に関する研究

完了NCT03481634第3相

The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).

対象疾患:
Diabetic Macular Edema

成人の進行性B細胞性非ホジキンリンパ腫患者におけるチサゲンレクロイセル

実施中(募集終了)NCT03570892第3相

This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.

対象疾患:
Non-Hodgkin Lymphoma