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Drug Information available for: Macitentan. Save this study. Actual Study Start Date :. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government.

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Eligibility Criteria. Subjects randomized to the placebo arm received one tablet of placebo every day for at least 24 to maximum 52 weeks. An echocardiogram is considered valid if its quality is sufficient to allow accurate assessment of LVEF and if it is reflective of the true status of the subject Cardiovascular co-morbidities e.

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Arms and Interventions. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. Read our disclaimer for details. Study Type :.

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Contacts and Locations. Active Comparator: Macitentan Subjects randomized to the macitentan arm receives one tablet of macitentan 10 mg every day for at least 24 to maximum 52 weeks.

Please refer to this study by its ClinicalTrials. Actual Enrollment :.

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Krakowski Szpital Specjalityczny im. FDA Resources. Last Update Posted : March 24, Study Description.

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Interventional Clinical Trial. Drug: Macitentan macitentan 10 mg; film-coated tablet; oral use Other Name: ACT Placebo Comparator: Placebo Subjects randomized to the placebo arm received one tablet of placebo every day for at least 24 to maximum 52 weeks. Actual Primary Completion Date :. Actual Study Completion Date :.

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Iliescu Sectia cardiologie III. May 15, Key Record Dates. Placebo Comparator: Placebo Subjects randomized to the placebo arm received one tablet of placebo every day for at least 24 to maximum 52 weeks.

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Wojewodzki Szpital Specjalistyczny im. Drug: Placebo film-coated tablet identical to the macitentan tablet ; oral use. This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction HFpEF and pulmonary vascular disease.

A study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction and pulmonary vascular disease (serenade)

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Study record managers: refer to the Data Element Definitions if submitting registration or information.

More Information. Outcome Measures. Changes in this marker may reflect reduction in cardiac load and left ventricular wall stress; reductions in NT-proBNP have been associated with improved outcomes in HF. Talk with your doctor and family members or friends about deciding to a study.

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Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Phase 2.

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Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Additional Information: To learn how to participate in this trial please. Philadelphia, Pennsylvania, United States, General University Hospital II. Universitaetsklinikum Schleswig-Holstein Campus Kiel.

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Search for terms x. Drug: Macitentan Drug: Placebo.

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Institutul de urgenta pentru Boli Cardiovasculare Prof. NT-proBNP is one of the best established cardiovascular.

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The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide NT-pro-BNP as compared to placebo in these patients. For general information, Learn About Clinical Studies.