治験一覧
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閉経後乳がん患者における非ステロイド性アロマターゼ阻害剤とアベマシクリブ（LY2835219）の併用療法に関する研究
本研究の主な目的は、閉経後乳がん患者における非ステロイド性アロマターゼ阻害剤（NSAI）とアベマシクリブの併用療法の有効性を評価することです。参加者は、アベマシクリブまたはプラセボを2:1の割合で無作為に割り付けられます。
脊髄小脳変性症（SCD）患者におけるKPS-0373の長期研究
The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients
黄斑円孔手術後の錐体外節先端の非対称的な回復と中心窩の変位
Evaluation of asymmetry in recovery of cone outer segment tips and foveal displacement after macular hole surgery
加齢黄斑変性症に対するラニビズマブ治療
To establish the correlation between visual acuity improvement and QOL measurement after ranibizumab treatment for AMD patients.
上皮成長因子受容体（EGFR）変異を有する非小細胞肺癌（NSCLC）患者を対象としたASP8273の非盲検試験
Purpose of the study is to determine the following in patients with non-small cell lung cancer (NSCLC) harboring EGFR activating mutations. * the safety and tolerability of ASP8273. * the pharmacokinetics (PK) of ASP8273. * the antitumor activity of ASP8273.
ペメトレキセド再投与とベバシズマブ併用療法の安全性と有効性
For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab continuous maintenance might be better treatment option, considering the results from AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients. Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with bevacizumab,we conducted this study.
HOMA-Rによる、本態性高血圧症および2型糖尿病患者のインスリン抵抗性に対するアジルサルタンとテルミサルタンの効果を比較検討する研究
Multicenter, randomized, open-label, parallel-group exploratory study to explore the effects of azilsartan (Azirva), compared with telmisartan, on insulin resistance in participants with essential hypertension complicated by type 2 diabetes mellitus
日本人喘息患者（症状が良好にコントロールされている患者）における、フルチカゾンフランカルボン酸エステル（FF）100μg 1日1回投与とフルチカゾンプロピオン酸エステル（FP）250μg 1日2回投与、およびFP 100μg 1日2回投与の有効性および安全性を比較する研究
The primary aim of this study is to clarify the position of FF and FF/Vilanterol (VI) 100/25 micrograms (mcg) compared with existing therapies by assessing FF dosage equivalent to low to middle-dose inhaled corticosteroids (ICS). The study is divided into Run-in period, Period 1 (open-label treatment), Period 2 (double blind treatment) and Follow-up. Subjects with well controlled asthma after completing a run-in period of 4 weeks will be switched from middle-dose ICS/long acting beta 2 agonist (LABA) equivalent dose to once-daily FF/VI 100/25 mcg for an 8 weeks treatment period (Period 1). After this, subjects will be randomized in a 1:1:1 ratio to receive either FP 250 mcg twice daily, FP 100 mcg twice daily or FF 100 mcg once daily in a 12 week double blind treatment period (Period 2). There will be a 1 week Follow-up Period following completion of the double-blind treatment period, or early withdrawal from the study. Overall , the total duration of subject's participation in the study will be for 25 weeks. RELVAR is a registered trademark of the GSK group of companies.
AdaptResponse臨床試験
The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).
アトピー性皮膚炎の小児患者を対象としたE6005の第1/2相試験
This is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment. Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group (childhood - adolescent: 7 to 15 years of age) and a younger group (children: 2 to 6 years of age) according to the sequential cohorts by confirming the safety.
前立腺癌の男性において、薬物療法または外科的去勢が奏効せず、癌が骨に転移し、化学療法を受けておらず、症状が全くないか軽度の場合、ラジウム223二塩化物とアビラテロン酢酸塩をプラセボとアビラテロン酢酸塩と比較する。
To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.
アジルサルタン錠の特別薬物使用監視：長期使用
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.
梅ペースト（Prunus mume）と生姜粉末の併用投与の効果
This study is designed to evaluate the effect of ume paste and ginger powder on glucose metabolism in prediabetic subjects.
CD20陽性、低腫瘍量濾胞性リンパ腫患者の一次治療におけるPF-05280586（リツキシマブ-ファイザー）またはMabThera®（リツキシマブ-EU）の臨床試験（REFLECTIONS B328-06）
This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.
早期アルツハイマー病におけるラナベセスタット（LY3314814）の有効性および安全性に関する研究
The purpose of this study is to assess the efficacy and safety of lanabecestat compared with placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study will test the hypothesis that lanabecestat is a disease-modifying treatment for participants with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2 lanabecestat treatment groups compared with placebo.
プラチナ製剤を含む治療に失敗した局所進行性または転移性非小細胞肺癌患者を対象とした、アテゾリズマブとドセタキセルの比較研究
This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 \[anti-PD-L1\] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
日本人における黄斑疾患の臨床経過に関するコホート研究
Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic macular edema (DME), and so forth. Patients with such macular diseases are registered and and are followed up for 5 years with appropriate treatment for each patient. By the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.
難治性転移性大腸がんにおけるニンテダニブ（BIBF 1120）とプラセボの比較試験（LUME-Colon 1）
The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.
慢性腎臓病（CKD）に伴う貧血を有する非透析依存性（NDD）患者におけるGSK1278863の安全性および有効性を評価する研究
This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the control arm. For those randomized to the control arm, the decision around whether the subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose to achieve and maintain Hgb concentrations within the target range should be based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value being considered. The study consists of a screening phase of at least 4 weeks, a 24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after completing treatment. It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.
心血管イベントのリスクが高い2型糖尿病患者を対象とした、インスリンデグルデクとインスリングラルギンの心血管安全性比較試験
This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.