Cardiac catheterization performed within 6 months prior to Screening showing end-expiratory PAWP or LVEDP > 15 mmHgĬ. diuretics at a healthcare facility) within 12 months prior to Screeningī. HF hospitalization (defined as HF as the major reason for hospitalization or treatment for HF lasting > 12 hours and/or including i.v. Subjects with at least one of the following:Ī. LVEF ≥ 40% (by echocardiography at screening)Ĥ. Signs or symptoms of heart failure requiring treatment with at least one oral diuretic (any type)Ģ. ![]() – El empeoramiento de la insuficiencia cardíacaġ. The secondary objective of the study is to evaluate the effect of macitentan 10 mg as compared to placebo on:Įvaluar el efecto de 10 mg de macitentan en comparación con placebo en: ![]() The primary objective of the study is to evaluate whether macitentan 10 mg reduces NT-pro-BNP versus placebo at Week 24 in subjects with HFpEF and pulmonary vascular diseaseĮvaluar si 10 mg de macitentan reducen la prohormona N-terminal del péptido natriurético cerebral (NT-proBNP) en comparación con el placebo en la semana 24 en pacientes con insuficiencia cardíaca con fracción de eyección preservada (ICFEP) y vasculopatía pulmonar. Heart failure with preserved ejection fractionĬondition being studied is a rare disease Esto aumenta carga de trabajo del corazón derecho y puede conducir a insuficiencia cardíaca derecha.ĭiseases - Cardiovascular Diseases Į.1.2 Medical condition or disease under investigation Insuficiencia cardíaca izquierda puede conducir a mayor presión en los vasos sanguíneos del pulmón. This increases the right heart workload and may lead to right heart failure. Left heart failure (inability of the heart to pump enough blood) may lead to increased pressure in the lung blood vessels. Medical condition in easily understood language Insuficiencia cardíaca con fracción de eyección preservada y vasculopatía pulmonar Heart failure with preserved ejection fraction and pulmonary vascular disease Medicinal product containing genetically modified organismsĮ.1 Medical condition or disease under investigation ![]() Immunological medicinal product (such as vaccine, allergen, immune serum) one involving a medical device)Ĭommittee on Advanced therapies (CAT) has issued a classification for this productĬombination product that includes a device, but does not involve an Advanced Therapy The IMP has been designated in this indication as an orphan drug in the Communityĭ.3.8 to D.3.10 IMP Identification Details (Active Substances)Īctive substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)Ĭombination ATIMP (i.e. Name of the Marketing Authorisation holderĬountry which granted the Marketing Authorisation IMP to be used in the trial has a marketing authorisation Status of the IMP to be used in the clinical trial Trial is part of a Paediatric Investigation PlanĮMA Decision number of Paediatric Investigation Plan Name or abbreviated title of the trial where available Un estudio para evaluar si macitantan es un tratamiento eficaz y seguro para pacientes con insuficiencia cardíaca con fracción de eyección preservada y enfermedad vascular pulmonar non-technical, languageĪ study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction and pulmonary vascular disease ![]() Title of the trial for lay people, in easily understood, i.e. Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (seeĪ multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular diseaseĮstudio de fase IIb, multicéntrico, con doble enmascaramiento y controlado con placebo para evaluar la eficacia y la seguridad de macitentan en pacientes con insuficiencia cardíaca con fracción de eyección preservada y vasculopatía pulmonar. Older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). The register also displays information on The EU Clinical Trials Register currently displaysĬlinical trials with a EudraCT protocol, of whichĪre clinical trials conducted with subjects less than 18 years old. Interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/ECĬlinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine developmentĮU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through theĬlinical Trials Information System (CTIS). Allows you to search for protocol and results information on:
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