治験一覧
8,963 件中 5261〜5280 件を表示
2型糖尿病患者における高脂血症およびインスリン抵抗性に対するダパグリフロジンの効果（DAPHNIS試験）
The investigators will investigate whether dapagliflozin (FORXIGA) might improve lipoprotein metabolism as well as hyperglycemia in Japanese patients with type II diabetes mellitus whose HbA1c levels are less than 7.0% (from 20 to 65 years of age). The investigators will examine changes of fasting lipoprotein profile including TG, TC, HDL-C, apoB-48 and RemL-C before and after the 8 weeks administration of dapagliflozin.
Adept™2試験においてrFVIIaアナログに5日間以上曝露された患者の唾液サンプルを用いた薬理遺伝学的検査
This study is conducted globally. This study describes pharmacogenetic testing of saliva samples from patients who participated in the NN1731-3562 trial (adept™2) (NCT01392547). The objective is to determine the HLA (human leukocyte antigen) type and polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue.
IFNとDAAのHCV SVRの追跡調査（IFDACS研究）
The study is designed to provide long term clinical and virologic follow up in subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no treatment is provided for HCV infection.
切除不能進行性または再発性食道癌におけるニボルマブの研究
The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.
進行性固形悪性腫瘍を対象としたAZD2014の日本における第I相臨床試験
The primary objective of this study is to investigate the safety and tolerability of continuous and/or intermittent dosing of AZD2014 when given orally to patients with advanced solid malignancies.
成人アジア人固形腫瘍患者を対象とした、AZD1775とカルボプラチンおよびパクリタキセルの併用療法に関する第Ib相試験
This is a phase Ib, open-label, multicentre study of AZD1775 administered orally in monotherapy and in combination with carboplatin and paclitaxel to Asian patients with advanced solid tumours.
XIENCE Xpedition エベロリムス溶出冠動脈ステントの日本における市販後調査（XIENCE Xpedition SV Japan PMS）
The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.
PALbociclib 共同補助療法研究
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.
進行性固形悪性腫瘍患者におけるDS-8201aの臨床試験
This is an open-label, two-part, multicenter study to evaluate the safety and tolerability of DS-8201a in participants with advanced solid malignant tumors.
MT203の単回投与試験
The purpose of this study is to evaluate safety, pharmacokinetics and pharmacodynamics of single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male participants.
てんかん患者における補助療法として投与されたペランパネル（E2007）の安全性および忍容性を評価するための非盲検延長試験
To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in participants with epilepsy. This study will be continued until perampanel is commercially available.
再発・難治性多発性骨髄腫の日本人患者におけるパノビノスタットとボルテゾミブおよびデキサメタゾンの併用療法に関する研究
The purpose of this study was to evaluate the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma.
既存の抗糖尿病薬で血糖コントロールが不十分な高齢2型糖尿病患者におけるHOE901-U300とランタスの安全性および有効性の比較
Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in: * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event from 22:00 to 08:59 next morning * Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL \[3.9mmol/L\]) hypoglycemia event * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event occurring at any time of day * HbA1c change
クローン病患者を対象としたMT-1303の延長試験
The primary objectives of the study are: -To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）
レビー小体型認知症（DLB）患者におけるアリセプトの市販後臨床試験
The purpose of this study is to confirm the efficacy of Aricept in patients with dementia with Lewy bodies (DLB).
大うつ病エピソードを伴う双極性障害患者における、異なる強度のFK949E製剤の切り替え効果を評価する研究
The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet at the equivalent total daily dose in bipolar disorder patients with major depressive episodes.
OX40アゴニストPF-04518600単独投与および4-1BBアゴニストPF-05082566との併用投与に関する研究
To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
日本人SJIA患者におけるカナキヌマブの有効性および安全性に関する研究
This was a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA) data at Week 28 and 48 from this study supported a registration submission of canakinumab in the indication of SJIA in Japan.
日本人成人におけるSA4Agの安全性、忍容性、および免疫原性に関する研究
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to \<86 years.
シェーグレン症候群を伴うドライアイ患者におけるKCT-0809の長期研究
The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in dry eye patients with Sjögren's syndrome.