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Aug 29, 2013 · Current therapies for pulmonary arterial hypertension have been adopted on the basis of short-term trials with exercise capacity as the primary end point. We assessed the efficacy of macitentan,...
- Tomás Pulido, Igor Adzerikho, Richard N. Channick, Marion Delcroix, Nazzareno Galiè, Hossein-Ardesch...
- 2013
Jun 18, 2014 · The recently published SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome) trial represents an important landmark in the history of clinical trials in PAH being the largest and longest clinical study conducted thus far in PAH patients with morbidity and mortality events as primar...
- Karim Said
- 2014
- Funding
- Medical Writing and Editorial Assistance
- Authorship
- Author Contributions
- List of Investigators
- Prior Presentations
- Disclosures
- Compliance with Ethics Guidelines
- Data Availability
The study was funded by Actelion Pharmaceuticals, Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson. The study sponsor also funded the journal’s Rapid Service and Open Access fees.
Medical writing support was provided by Jatta Huotari and Ioanna Ntai of eluSCIdate ltd (Meggen, Switzerland) and was funded by Actelion Pharmaceuticals, Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
All authors contributed to the writing of the manuscript. Rogério Souza, Marion Delcroix, Nazzareno Galié, Pavel Jansa, Sanjay Mehta, Tomás Pulido, Lewis Rubin, B.K.S. Sastry, Gérald Simonneau, Olivier Sitbon, Adam Torbicki, and Richard N. Channick contributed to collection of the data as investigators and to interpretation of the results. Liliya C...
Argentina—Sanatorio de la Trinidad Mitre, Buenos Aires: G Bortman; Hospital Universitario—Fundacion Favaloro, Buenos Aires: JO Caneva; Hospital Britanico—Servico de Cardiologia, Buenos Aires: FJ Chertcoff; Centro Medico 21 de Diciembre, Santa Fe: J Chirife; Instituto De Cardiologia de Corrientes, Corrientes: E Perna; Hospital Privado Centro Medico ...
These data have been partially previously presented at the ATS Congress 2017 (19–24 May 2017, Washington DC, US).
Rogério Souza has received consulting and speaker fees from Acceleron, Bayer, and Janssen Pharmaceutical Companies of Johnson & Johnson. Marion Delcroix has received an institutional research grant from Janssen Pharmaceutical Companies of Johnson & Johnson; and institutional speaker and advisory board fees from Janssen Pharmaceutical Companies of J...
The study was conducted in accordance with the Declaration of Helsinki. The protocol was approved by the institutional review board/independent ethics committee at each site. Written informed consent was obtained from all patients.
The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu.
Dec 26, 2017 · SERAPHIN was a double-blind, placebo-controlled, event-driven phase III trial that evaluated the effects of long-term treatment with macitentan, an oral endothelin receptor antagonist, in patients with pulmonary arterial hypertension (PAH).
- Pavel Jansa, Tomás Pulido
- 10.1007/s40256-017-0260-1
- 2018
- Am J Cardiovasc Drugs. 2018; 18(1): 1-11.
Aug 29, 2013 · Contribution to the Literature: The SERAPHIN trial showed that high and low doses of macitentan are safe and efficacious compared with placebo in improving hemodynamics, symptoms, and intermediate-term morbidity.
Jun 1, 2014 · The recently published SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome) trial represents an important landmark in the history...
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Jun 18, 2014 · SERAPHIN trial investigated whether long-term treatment with the new endothelin receptor antagonist macitentan would reduce the risk of mortality and morbidity in PAH patients.
