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Khmel'nyts'kyy, Ukraine

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  • Integrated Approach in Frail Older People with Atrial Fibrillation

    Controlled study, testing a structured implementation of an appropriate management of elderly AF patients with multimorbidity in clinical practice (adapting the ABC pathway and integrating the means of CGA) versus usual care; it is designed to provide reliable evidence of an active holistic integrated management approach to a common, multimorbid and 'high risk' clinical condition. AFFIRMO use a novel platform (iABC) in a cluster randomized trial design, randomizing centres to iABC versus usual care. Centres will be selected in each participating country (Bulgaria, Denmark, Italy, Romania, Serbia and Spain) under the responsibility of National Coordinators on the basis of a demonstrated interest in managing patients with AF. The 8-10 participating clusters in each country (see study size below) will be randomized in a 1:1 ratio to receive a quality-improvement intervention (iABC, experimental group) or 'usual care' practice (control group). The randomization will occur in each Country once all clusters selected in the Country have obtained IRB approval. The allocation schedule for random assignment of care models (iABC or usual care) to sites will be computer generated at the Central Coordinating Centre. The clusters in each Country will be stratified in 2 groups: Centres with or without interventional electrophysiology laboratory for AF ablation.

    Phase

    N/A

    Span

    95 weeks

    Sponsor

    Heart Care Foundation

    Pernik

    Recruiting

  • A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2

    Study B7981080 is a Phase 3 randomized, double-blind, multicenter study with a 52-week placebo-controlled period (Part Ia) followed by a double-blind 52-week extension period (Part Ib) that includes randomized dose-up/down titration and a de novo 52-week non-randomized open-label cohort (Part II), investigating the efficacy, safety, and tolerability of ritlecitinib 100 mg QD and 50 mg QD compared with placebo in adult participants with nonsegmental active or stable vitiligo

    Phase

    3

    Span

    192 weeks

    Sponsor

    Pfizer

    Pernik

    Recruiting

  • A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.

    This is a multicenter, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of dexpramipexole in adults and adolescents with severe, inadequately controlled asthma with eosinophilic phenotype on medium to high-dose inhaled corticosteroids (ICS )and at least one additional asthma controller medication with or without oral corticosteroids (OCS). Approximately 1400 participants will be randomized globally. Participants will receive dexpramipexole, or placebo, administered orally, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 4 weeks.

    Phase

    3

    Span

    183 weeks

    Sponsor

    Areteia Therapeutics

    Pernik

    Recruiting

  • A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

    Phase

    3

    Span

    300 weeks

    Sponsor

    Chiesi Farmaceutici S.p.A.

    Pernik

    Recruiting

  • A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

    Phase

    3

    Span

    209 weeks

    Sponsor

    Hoffmann-La Roche

    Pernik

    Recruiting

  • A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart

    Phase

    3

    Span

    197 weeks

    Sponsor

    Boehringer Ingelheim

    Pernik

    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.

    Pernik

    Recruiting

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

    Phase

    3

    Span

    192 weeks

    Sponsor

    Janssen Research & Development, LLC

    Pernik

    Recruiting

  • The AIRTIVITY® Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis

    Phase

    3

    Span

    175 weeks

    Sponsor

    Boehringer Ingelheim

    Pernik

    Recruiting

  • Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

    Phase

    3

    Span

    184 weeks

    Sponsor

    AstraZeneca

    Pernik

    Recruiting

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