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Ul.v. Spanyola 43, Žilina, Slovakia

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  • Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

    Phase

    2/3

    Span

    252 weeks

    Sponsor

    Exelixis

    Zilina

    Recruiting

  • A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

    Phase

    3

    Span

    151 weeks

    Sponsor

    Teva Branded Pharmaceutical Products R&D, Inc.

    Zilina

    Recruiting

  • A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations

    This is a Phase II, randomised, placebo-controlled, double-blind, dose range-finding, multi-centre study to assess the efficacy and safety of inhaled AZD8630 administered at 3 doses via an inhaler in adult patients with uncontrolled asthma, at risk of an exacerbation. The study duration up to 57 weeks for participants in the optional safety extension study and up to 17 weeks for those not included. The maximal treatment period is up to 52 weeks. This study will be conducted in approximately 220 centres in 20-25 countries. Approximately 516 patients will be randomised globally

    Phase

    2

    Span

    84 weeks

    Sponsor

    AstraZeneca

    Zilina

    Recruiting

  • A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes

    Phase

    2

    Span

    64 weeks

    Sponsor

    Novo Nordisk A/S

    Zilina

    Recruiting

  • A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

    Phase

    3

    Span

    217 weeks

    Sponsor

    Novo Nordisk A/S

    Zilina

    Recruiting

  • A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome

    Phase

    3

    Span

    192 weeks

    Sponsor

    Janssen Research & Development, LLC

    Zilina

    Recruiting

  • A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE

    Phase

    3

    Span

    199 weeks

    Sponsor

    Janssen Research & Development, LLC

    Zilina

    Recruiting

  • A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

    This study consists of a core and extension periods. The Core period (6 arms) has a total duration of up to 60 weeks including a double-blind placebo-controlled treatment period until Week 24 followed by open-label treatment with remibrutinib up to Week 52. The primary endpoint for all CINDU subtypes is assessed at Week 12. The Core period consists of: - Screening period (up to 4 weeks): During the screening period, participants who have provided informed consent will be assessed for study eligibility. - Double-blind, placebo-controlled treatment period (24 weeks): 24 weeks of double-blind treatment with remibrutinib or placebo. - Open-label treatment period (28 weeks): 28 weeks of open-label treatment with remibrutinib. - Follow-up period: 4 weeks of treatment free follow-up. The open-label extension period consists of observation and treatment period. At the end of the core period of the study, if participants continue to experience symptoms, they will transition to the treatment period in OLE. If they do not experience symtpoms they will transition to the observation period in the OLE. The duration of the Open-label Extension period will be approximately 3 years where participants can switch from observation to treatment depending on if they start developing symptoms. Only those participants participating in the Open-label Extension Treatment period will receive remibrutinib. The participants in the Open-label Extension Observation period will not receive remibrutinib

    Phase

    3

    Span

    265 weeks

    Sponsor

    Novartis Pharmaceuticals

    Zilina

    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

    Zilina

    Recruiting

  • A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

    Phase

    3

    Span

    193 weeks

    Sponsor

    AstraZeneca

    Zilina

    Recruiting

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