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2種類以上の薬剤を服用している高血圧症患者(治療抵抗性高血圧症患者を含む)におけるバクスドロスタットの有効性と安全性を調査する研究

完了NCT06034743第3相

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

対象疾患:
Resistant HypertensionUncontrolled Hypertension

実際の臨床現場における中等度から重度のクローン病(CD)の成人患者を対象に、ウパダシチニブの効果発現の速さと持続性を評価する研究。

実施中(募集終了)NCT05930275

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed. Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

対象疾患:
Crohn's Disease

早期アルツハイマー病患者を対象としたLIPUS-Brainの重要な研究

実施中(募集終了)NCT05983575第3相

This study is a multicenter, randomized, double-blinded, placebo-controlled Phase 3 study comparing LIPUS-Brain transcranial low-intensity pulsed-wave ultrasound device to placebo in patients with Early Alzheimer's Disease. The primary objective of the study is to assess changes in ADAS-J-cog-14 scores from baseline to 72 weeks.

対象疾患:
Alzheimer Disease, Early Onset

ATGAM一般調査

実施中(募集終了)NCT06039020

The objective of this study is to confirm the safety of ATGAM in patients with moderate to severe aplastic anemia under the actual use in Japan. The registration criteria is patients with moderate to severe aplastic anemia who receive ATGAM. The observation period is 24 weeks (6 months) from the start of administration (Day 1). However, in cases where treatment has been completed or discontinued less than 24 weeks after the start of administration, observation is continued until completion (discontinuation) of treatment.

対象疾患:
Aplastic Anemia

既治療の非小細胞肺癌におけるSGN-B6Aとドセタキセルの比較研究

実施中(募集終了)NCT06012435第3相

This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy. This clinical trial uses an experimental drug called sigvotatug vedotin, which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle. This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

対象疾患:
Carcinoma, Non-Small-Cell Lung

近視性脈絡網膜萎縮症(PAMyCA)患者を対象としたPAL-222の臨床試験

実施中(募集終了)NCT05658237該当なし

The goal of this clinical trial is to assess efficacy and safety in patients with myopic chorioretinal atrophy. The main question it aims to answer are: • Percentage of changes in the chorioretinal atrophic area Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy. Researchers will compare non-therapeutic eye to see if the changes is significant different.

対象疾患:
Myopic Chorioretinal Atrophy

慢性副甲状腺機能低下症患者におけるエネボパラチド(AZP-3601)の安全性と有効性の評価

実施中(募集終了)NCT05778071第3相

This study is investigating the safety and efficacy of eneboparatide (AZP-3601) in patients with chronic hypoparathyroidism (cHP). During the first 24 weeks of the trial, participants will be randomized to receive eneboparatide or placebo. Study treatment is blinded: patients and doctors will not know which group each patient has been randomized to. All patients will start with a fixed dose of study treatment (eneboparatide or placebo), administered subcutaneously with a pre-filled pen. Study treatment will be individually titrated. After completion of the first 24 weeks, patients will be treated in the open label extension part of the study for 132 weeks. During this phase, all patients (including patients that were in the placebo group) will receive eneboparatide.

対象疾患:
Chronic HypoparathyroidismEndocrine System DiseasesParathyroid Diseases

ブライトライン4:脱分化型脂肪肉腫と呼ばれる癌患者におけるブリギマドリンの忍容性を検証する研究

完了NCT06058793第3相

This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumours are positive for MDM2. The purpose of this study is to find out whether a medicine called brigimadlin (BI 907828) is tolerated by and helps people with DDLPS. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Participants take brigimadlin as a tablet once every 3 weeks. Participants may continue to take brigimadlin as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check participants' health and take note of any unwanted effects. The doctors also regularly check tumour size.

対象疾患:
Liposarcoma, Dedifferentiated

全身性重症筋無力症(gMG)の試験参加者によるロザノリキシズマブの自己投与を評価する第3相オープンラベルクロスオーバー試験

完了NCT05681715第3相

The purpose of this study is to evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.

対象疾患:
Generalized Myasthenia Gravis

偶発性低体温症国際登録

募集中NCT06200285

Transient mild hypothermia (core body temperature 35-32°C) is common and usually without consequences for the brain or other organs. However, prolonged severe accidental hypothermia (core body temperature below 28°C) due to accidents is rare, and usually fatal in more than 50% of cases. Little is known on its physiopathology, on prognostic factors for rewarming decision or ideal rewarming techniques for better survival. Furthermore, complications after successful rewarming are extremely frequent and very often severe or fatal. Accidental hypothermia is a frequent problem during the winter months and can be caused by snow sport accidents, near drowning and urban cold exposure. The International Hypothermia Registry's principle goal is to increase knowledge on accidental hypothermia by creating the largest database on accidental hypothermia which will comprise enough patient data to give a statistical power since the causes of accidental hypothermia and its treatment varies greatly. The International Hypothermia Registry (IHR) will enable improvement of pre- and in-hospital treatment and rewarming methods, study survival predictors and prevention of post-rewarming complications. By this way, the IHR will permit the establishment of evidence-based diagnosis and treatment guidelines.

対象疾患:
Accidental Hypothermia

中等度から重度のアトピー性皮膚炎患者(生後6ヶ月から18歳未満)を対象としたレブリキズマブ(LY3650150)の長期安全性および有効性を評価する試験

招待制NCT05735483第3相

The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \<18 years of age with moderate-to-severe atopic dermatitis. This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.

対象疾患:
Atopic DermatitisEczema

肝硬変前期の非アルコール性脂肪性肝炎(NASH)患者を対象としたエフィノペグデュチドの臨床試験(MK-6024-013)

完了NCT05877547第2相

The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.

対象疾患:
Fatty Liver, NonalcoholicNAFLDNon-alcoholic Fatty Liver DiseaseNonalcoholic Fatty Liver DiseaseNonalcoholic Steatohepatitis

心不全患者におけるXXB750の概念実証および用量設定試験

中止NCT06142383第2相

This was a multicenter, randomized, placebo- and active-controlled, parallel-group, 24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in participants with HFrEF/HFmrEF.

対象疾患:
Heart Failure

プラチナ製剤、エトポシド、デュルバルマブ併用療法後の進展期小細胞肺癌(ES-SCLC)の第一選択治療におけるタルラタマブとデュルバルマブの併用とデュルバルマブ単独の併用を比較する試験

実施中(募集終了)NCT06211036第3相

The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).

対象疾患:
Extensive-Stage Small-Cell Lung CancerSmall-Cell Lung Cancer

インスリングラルギン、メトホルミン、SGLT-2阻害薬の併用の有無にかかわらず、2型糖尿病患者におけるオルフォルグリプロン(LY3502970)の有効性を評価する試験

完了NCT06109311第3相

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

対象疾患:
Type 2 Diabetes

重症好酸球性喘息の青年および成人におけるデクスプラミペキソールの効果を評価する研究。

中止NCT05763121第3相

This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.

対象疾患:
AsthmaAsthma; EosinophilicEosinophilic Asthma

肺炎球菌感染症リスク増加成人におけるV116の安全性と免疫原性(V116-008)

完了NCT05696080第3相

The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination within each vaccination group separately.

対象疾患:
Pneumococcal Infection

マイクロサテライト不安定性またはミスマッチ修復欠損と呼ばれる特定の DNA 変異を持つ癌患者における HRO761 単独または併用療法の研究。

募集中NCT05838768第1相

The main purpose of the study is to evaluate the safety and tolerability of HRO761 and identify the recommended dose(s), i.e., the optimal safe and active dose of HRO761 alone or in combination with pembrolizumab or irinotecan that can be given to patients who have cancers with specific molecular alterations called MSIhi (Microsatellite Instability-high) or dMMR (Mismatch Repair Deficient) that might work best to treat these specific cancer types and to understand how well HRO761 is able to treat those cancers.

対象疾患:
MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers

HIV-1抗レトロウイルス治療未経験者におけるDOR/ISL(MK-8591A-053)

実施中(募集終了)NCT05705349第3相

This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.

対象疾患:
HIV-1 Infection

びまん性大細胞型B細胞リンパ腫の第一選択治療としての皮下エプコリタマブ(レナリドミド併用または非併用)

実施中(募集終了)NCT05660967第2相

The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as EPKINLY™, GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.

対象疾患:
びまん性大細胞型B細胞リンパ腫