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進行性悪性腫瘍患者を対象としたPDR001の第I相臨床試験。

完了NCT02678260第1相

The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.

対象疾患:
Advanced Malignancies

原発開放隅角緑内障または眼圧亢進症患者におけるDE-117点眼液の有効性および安全性を評価する研究 -AYAME試験-

完了NCT02623738第2/第3相

The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.

対象疾患:
Ocular HypertensionPrimary Open Angle Glaucoma

高リン血症を伴う血液透析中の慢性腎臓病患者におけるASP1585の用量範囲設定試験

完了NCT02753894第2相

The objective of this study is to examine the clinical dose range of ASP1585 based on the efficacy, safety, and feasibility of treatment in chronic kidney disease patients on hemodialysis with hyperphosphatemia.

対象疾患:
Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

ボルテゾミブとデキサメタゾンを標準治療として受けている多発性骨髄腫患者におけるベネトクラクス(ABT-199)の評価に関する研究

完了NCT02755597第3相

This was a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.

対象疾患:
Relapsed/Refractory Multiple Myeloma

肝転移に対する拡散強調MRI

完了NCT02781935

The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination with other imaging modalities (multiparametric MRI and CT Scan) in determining the true status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for unresectable or borderline resectable colorectal liver metastasis (CRLM).

対象疾患:
Colon Cancer Liver MetastasisColorectal CancerMalignant Neoplasm of Rectum Metastatic to Liver

生物学的疾患修飾性抗リウマチ薬(DMARD)治療に不十分な反応を示す活動性関節リウマチ(RA)成人患者におけるフィルゴチニブとプラセボの比較

完了NCT02873936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

慢性閉塞性肺疾患を有する日本人患者におけるスピオルトレスピマットの長期使用

完了NCT02850978

Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting

対象疾患:
Pulmonary Disease, Chronic Obstructive

固形がん患者に対するモガムリズマブとニボルマブの術前併用療法に関する研究

完了NCT02946671第1相

To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and ONO-4538 (anti-PD-1). To assess the behavior of immune cells in peripheral blood and tumor.

対象疾患:
Esophageal CancerGastric CancerLung CancerOral CancerRenal Cancer

子宮内膜症患者を対象としたKLH-2109の後期第II相臨床試験

完了NCT02778919第2相

The purpose of this study is to evaluate the efficacy, safety, and dose-response relationship of KLH-2109 compared to placebo in Japanese patients with endometriosis.

対象疾患:
Endometriosis

進行固形癌におけるBMS-986207単独投与およびニボルマブとの併用投与、またはニボルマブとイピリムマブとの併用投与の試験

完了NCT02913313第1/第2相

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.

対象疾患:
Broad Solid Tumor

健康なアジア人および白人男性ボランティアにおけるBI 655066/ABBV-066(リサンキズマブ)の安全性、忍容性および薬物動態

完了NCT02596217第1相

Safety, tolerability and pharmacokinetics of single dose of BI 655066/ABBV-066 (risankizumab) in healthy Chinese, Japanese and Caucasian male volunteers.

対象疾患:
Healthy

長期特定薬剤使用に関する調査結果(イクスタンディカプセル)

完了NCT02669771

The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients.

対象疾患:
Castration-resistant Prostate Cancer

神経因性膀胱過活動による尿失禁を有する日本人患者におけるGSK1358820の有効性および安全性に関する研究

完了NCT02849418第3相

This study will evaluate the efficacy and safety of GSK1358820 in Japanese patients with neurogenic detrusor overactivity (NDO) with urinary incontinence, whose symptoms have not been adequately managed with medications for urinary incontinence due to NDO. This study consists of a screening phase up to 28 days followed by a double-blind Treatment phase 1 of 12 to 48 weeks wherein subjects will receive a single treatment of either GSK1358820 200 Units (U) injection or placebo injection. After the first treatment, subjects who meet the re-treatment criteria between 12 to 36 weeks can enter an open-label Treatment phase 2 to receive a second treatment with GSK1358820 200 U. Subjects will be permitted to receive re-treatment up to 2 times, and there should be a gap of minimum of 12 weeks since the previous treatment. The duration of overall treatment phases is 48 weeks. The total duration of participation for any subject will not exceed 52 weeks, including screening.

対象疾患:
Urinary Bladder, Overactive

1型糖尿病の小児および青年における、インスリンデグルデクとの併用における、速効型インスリンアスパルトとノボラピッド®の有効性および安全性の比較

完了NCT02670915第3相

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.

対象疾患:
DiabetesDiabetes Mellitus, Type 1

遠位膵切除術における脾静脈の可動化後の同時切除と分離切除の比較

不明NCT02871804第3相

Eligible patients will be centrally randomized to either Arm A (resection of the splenic vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together with the pancreas).

対象疾患:
Pancreatic Neoplasms

Gi(l)Otrif®の投与量調整に関する実世界データ

完了NCT02751879

This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.

対象疾患:
Carcinoma, Non-Small-Cell Lung

切除不能悪性黒色腫を有する日本患者を対象としたヤーボイ®の市販後調査

完了NCT02717364

This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study (regulatory postmarketing surveillance). Each physician will enroll patients who have received at least 1 dose of Yervoy, and each patient will be followed for up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile of Yervoy under routine, daily practice

対象疾患:
Melanoma

本態性高血圧症患者におけるCS-3150の臨床試験

完了NCT02890173第3相

To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.

対象疾患:
Essential Hypertension

常染色体優性多発性嚢胞腎患者に対するトルバプタンの有効性

不明NCT02729662該当なし

Investigation of the therapeutic effects of tolvaptan in patients with autosomal dominant polycystic kidney disease This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 5 years (data cut-off, Aug 31, 2020).

対象疾患:
Autosomal Dominant Polycystic Kidney Disease

術後ステージII/III結腸癌患者における癌治療関連症状の予防を目的としたART-123の探索的研究

完了NCT02792842第2相

The purpose of this study is to evaluate the efficacy and safety of ART-123 for the prevention of cancer treatment related symptoms in patients with postoperative stage II / III colon cancer.

対象疾患:
Postoperative Stage II/III Colon Cancer