治験一覧
8,963 件中 5161〜5180 件を表示
良性前立腺肥大症を示唆する下部尿路症状（BPH-LUTS）を有する参加者を対象としたタダラフィル（LY450190）の研究。
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as tadalafil in participants with benign prostatic hyperplasia who are being treated with an alpha1 blocker. This study has two treatment periods. Participants will receive tadalafil or placebo in each treatment period.
SPYRAL PIVOTAL - SPYRAL HTN-OFF MED 研究
The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.
新生血管性加齢黄斑変性症患者におけるアビシパーペゴルの安全性および有効性
This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.
HER2陰性ホルモン抵抗性手術不能または再発転移性乳がんに対するエリブリンの一次または二次化学療法としての治療
This is a observational study in a real-world setting, not requiring determining a dosage regimen, dose reduction criteria, rest period criteria and withdrawal criteria. The purpose of the study is to investigate the efficacy of eribulin as the first or second line chemotherapy to prolong overall survival and to explore factors affecting the survival in patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer who scheduled to receive the first or second line chemotherapy in clinical practice in Japan. The total duration of the study will be a maximum of 5 years, consisting of 2-year enrollment period and 3-year observational period; the duration of patient participation will be 3 years. All patients will receive adequate treatment for breast cancer which selected by the primary physician after enrollment using the Japanese Breast Cancer Society Clinical Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Investigators at the investigational sites will enter patient data into an electronic data capture (EDC) system up to the third chemotherapy in the study. The end of the study is defined as the time the last patient completes observational period. Patients will primarily be assessed by overall survival (OS) of the first line chemotherapy.
再発・難治性B前駆細胞急性リンパ性白血病の日本人患者におけるブリナツモマブの研究
This is an open-label, combined 2-part multicenter study to evaluate the efficacy, safety, and tolerability of blinatumomab in adult and pediatric Japanese patients with relapsed/refractory B-precursor ALL.
CDP870の長期治療試験（試験275-08-002または試験275-08-004）に参加している活動性関節リウマチ患者におけるCDP870自己注射の長期治療試験
The objective of this study is to evaluate the safety and efficacy of CDP870 self-injection administered for 24 weeks or longer in subjects who are participating in the long-term treatment study (Study 275-08-002 or Study 275-08-004) of CDP870 administered concomitantly with or without Methotrexate.
FMS様チロシンキナーゼ（FLT3）変異を有する再発性または難治性急性骨髄性白血病（AML）患者におけるASP2215と救済化学療法の比較試験
The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who were refractory to or had relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and determined the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants. This study also determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
注意欠陥・多動性障害（ADHD）の小児におけるチペピジン：二重盲検プラセボ対照試験
Tipepidine (3-\[di-2-thienylmethylene\]-1-methylpiperidine) has been used solely as a nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults has already been established. It is reported that tipepidine inhibits G-protein-coupled inwardly rectifying potassium (GIRK)-channel currents. The inhibition of GIRK channels by tipepidine is expected to modulate the level of monoamines in the brain. We put forward the hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD) symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK channels. The purpose of this double-blind, placebo-controlled trial is to confirm whether treatment with tipepidine can improve symptoms in pediatric patients with ADHD.
進行性消化管癌またはグアニル酸シクラーゼCを発現する転移性もしくは再発性胃腺癌もしくは胃食道接合部腺癌を有する、既治療のアジア人被験者におけるMLN0264
The purpose of this study is to evaluate the effects of MLN0264 in previously treated Asian participants with Advanced Gastrointestinal (GI) Carcinoma (Phase 1) or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (Phase 2) Expressing Guanylyl Cyclase C (GCC).
PCIの最適化：OCTとIVUSおよび血管造影による冠動脈ステント留置のガイドに関する多施設共同無作為化試験
The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation
固形がん患者を対象としたE7090の第1相試験
This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts: 1. Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and 2. Part 2 will comprise cohort expansions to further characterize the safety and tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with solid tumors characterized by genetic abnormalities in FGF/FGFR pathway.
胃排出に対する元素液体食と標準半固形食のランダム化比較試験
The purpose of this study is to compare the effect of either elemental liquid diet or standard semi-solid diet on gastric emptying in both healthy subjects and bedridden patients receiving gastrostomy feeding.
ASP015Kの新規錠剤と既存錠剤の生物学的同等性評価
The objective of this study is to evaluate the bioequivalence of a new tablet versus a current tablet of ASP015K under fasting conditions after single oral administration in healthy male subjects.
経カテーテル大動脈弁置換術におけるロータス弁の安全性および有効性に関する研究（REPRISE Japan）
The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at high or extreme risk for surgical valve replacement.
EGFR変異およびcMET増幅を有する進行性／転移性非小細胞肺癌患者におけるINC280単剤療法およびエルロチニブとの併用療法と化学療法との比較による安全性および有効性に関する研究
The purpose of this study was to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.
健康な日本人成人男性被験者におけるリルピビリン／テノホビル／エムトリシタビン単回経口投与後の薬物動態を評価する研究
The purpose of this study is to evaluate the pharmacokinetics (PK) of rilpivirine/Tenofovir/Emtricitabine (RPV/TFV/FTC) after a single-oral administration of Complera (the fixed-dose combination of RPV, FTC, Tenefovir disoproxil fumarate \[TDF\]) to healthy Japanese adult male participants.
冠動脈狭窄症の治療指針となる、圧力と流量の複合測定
This study evaluates the prognostic value and therapeutic potential of combined pressure and flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal medical therapy. Only lesions with a simultaneous reduction in both CFR and FFR will be treated with percutaneous coronary intervention (PCI).
2型糖尿病患者におけるベキサグリフロジン錠の効果を評価するための用量範囲探索試験
The purpose of this study was to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin is an orally administered drug for the treatment of T2DM and is classified as a Sodium Glucose co-Transporter 2 (SGLT2) Inhibitor. This study was to enroll both treatment naive and those subjects previously treated with one oral hypoglycemic agent (OHA). Approximately 320 subjects eligible for randomization was to receive bexagliflozin tablets, 5, 10, 20 mg or placebo, once daily for 12 weeks in an outpatient setting.
早期パーキンソン病患者を対象としたTVP-1012（1mg）の第3相臨床試験
The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (1 mg/day) administered to Japanese patients with early Parkinson's disease.
中等度から重度の成人アトピー性皮膚炎患者に対するデュピルマブ単剤療法の研究
This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).