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  • Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

    Phase

    3

    Span

    157 weeks

    Sponsor

    Incyte Corporation

    Creteil

    Recruiting

  • A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

    The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

    Phase

    3

    Span

    268 weeks

    Sponsor

    AstraZeneca

    Creteil

    Recruiting

  • PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies

    Phase

    4

    Span

    205 weeks

    Sponsor

    Groupe Francais De Pneumo-Cancerologie

    Creteil

    Recruiting

  • A French Multicenter Observational Retrospective Study of Rare Primary Liver Cancers

    The aim is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences.

    Phase

    N/A

    Span

    362 weeks

    Sponsor

    Federation Francophone de Cancerologie Digestive

    Creteil

    Recruiting

  • A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of ANX007 in Participants With Geographic Atrophy (GA)

    Phase

    3

    Span

    170 weeks

    Sponsor

    Annexon, Inc.

    Creteil

    Recruiting

  • Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

    The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

    Phase

    3

    Span

    165 weeks

    Sponsor

    AstraZeneca

    Creteil

    Recruiting

  • Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion

    RESAMEX is a prospective study evaluating the mechanisms of acquired resistance to amivantamab monotherapy in patients with advanced NSCLC with EGFR ins20. Biological analysis will be performed on circulating tumor deoxyribonucleic acid (ctDNA) at the time of disease progression and on tumor tissue at the time of disease progression when available. - ctDNA : The extraction of the ctDNA will be performed in an automated way with the Promega RSC LV cfDNA kit on Maxwell platform. Sequencing will be performed on NextSeq500 platform with a panel of 208 genes (including 190 genes with full coverage of coding regions, and 11 genes with coverage of introns involved in translocations) covering 800 kpb and at a target depth of 8000 X. - Tissue : Deoxyribonucleic acid (DNA) next generation sequencing (NGS) will be performed on tumor biopsy (10 slides of 5 microns) . Samples will be sent for centralized analysis to Centre de Recherche en Cancérologie de Marseille (CRCM), 27 Bd Lei Roure, 13009 Marseille (Prof. Tomasini and Gwenaël Lumet), and will be stored at Centre de Ressources Biologiques de l'Assistance Publique Hôpitaux de Marseille (CRB AP-HM), 264 Rue Saint-Pierre, 13005 Marseille.

    Phase

    N/A

    Span

    90 weeks

    Sponsor

    Groupe Francais De Pneumo-Cancerologie

    Creteil

    Recruiting

  • Study of PREMEdication Before Laryngoscopy in Neonates in France

    Laryngoscopy for intubation or less invasive surfactant administration (LISA) in neonates is a stressful and painful procedure that necessitates a sedo-analgesia except in the case of an immediate life-threatening emergency. Nevertheless, there are discrepancies in premedication practices amongst neonatal units. In order to optimize analgesia before laryngoscopy in neonates, the French neonatal society issued best practice guidelines in January 2023 for premedication before laryngoscopy in neonates. These guidelines were published in an English peer-reviewed journal and presented in national conferences. However, the implementation of new premedication protocols in neonatal units can be made difficult due to local habits, poor dissemination of the guidelines and a limited level of evidence on some premedication agents. Thus, conducting a survey one year after issuing the best practice guidelines on premedication seems important to evaluate French premedication practices and to evaluate the impact and dissemination of the guidelines

    Phase

    N/A

    Span

    4 weeks

    Sponsor

    Centre Hospitalier Intercommunal Creteil

    Creteil

    Recruiting

  • Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab

    Phase

    3

    Span

    217 weeks

    Sponsor

    Amgen

    Creteil

    Recruiting

  • Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

    Phase

    3

    Span

    251 weeks

    Sponsor

    Alexion Pharmaceuticals, Inc.

    Creteil

    Recruiting

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