Last updated on October 2017

Efficacy Safety and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension


Brief description of study

This Phase IIb, randomized, placebo-controlled, multicenter, international study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone (Esbriet) treatment in participants with advanced IPF and intermediate or high probability of Group 3 pulmonary hypertension (PH) who are on a stable dose of pirfenidone with demonstrated tolerability. Participants will be randomized to receive 1 year of treatment with either oral sildenafil or matching placebo while continuing to take pirfenidone.

Clinical Study Identifier: NCT02951429

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Clin Univ de Bxl H pital Erasme
Bruxelles, Belgium
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Cliniques Universitaires St-Luc
Bruxelles, Belgium
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UZ Leuven Gasthuisberg
Leuven, Belgium
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CHU UCL Mont-Godinne
Mont-godinne, Belgium
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Hotel Dieu Hospital
Kingston, ON Canada
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CHUM H pital Notre-Dame
Montreal, QC Canada
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Institut universitaire de cardiologie et de pneumologie de Qu bec (H pital Laval)
Ste. Foy, QC Canada
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Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN
Praha 4 - Krc, Czechia
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Clinical Research Center (CRC), Faculty of Medicine, Alexandria University
Alexandria, Egypt
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Kasr El-Aini-Chest Unit; Department 3-Chest Unit
Cairo, Egypt
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Ain Shams University Hospital-Chest unit; Chest unit
Cairo, Egypt
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Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gef chirurgie
Coswig, Germany
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Klinik Donaustauf Zentrum f r Pneumologie
Donaustauf, Germany
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Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
Essen, Germany
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Klinikum Fulda gAG; Universit tsmedizin Marburg, Campus Fulda
Fulda, Germany
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Universit tsklinikum Standort Gie en Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie
Gießen, Germany
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Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany
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Fachklinik f r Lungenerkrankungen
Immenhausen, Germany
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Klinikum der Universit t M nchen; Campus Gro hadern; Med. Klinik und Poliklinik V
München, Germany
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Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology
Athens, Greece
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University General Hospital of Athens "Attikon", B' University Pulmonary Clinic
Chaidari, Greece
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University General Hospital of Heraklio, Pulmonary Clinic
Heraklio, Greece
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Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, Hungary
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Semmelweis Egyetem X; Pulmonologiai Klinika
Budapest, Hungary
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Soroka; Pulmonary Clinic
Beer Sheba, Israel
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Carmel Medical Center; Pulmonary Institute
Haifa, Israel
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Shaare Zedek Medical Center; Pulmonary Inst.
Jerusalem, Israel
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Hadassah Medical Center; Pulmonary Institute
Jerusalem, Israel
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Meir Medical Center; Pulmonary Dept
Kfar Saba, Israel
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Beilinson Medical Center; Pulmonary Inst.
Petach Tikva, Israel
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Kaplan Medical Center
Rehovot, Israel
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Ospedale Morgagni-Pierantoni; U.O. Pneumologia
Forlì, Italy
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A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio
Modena, Italy
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Ospedale San Giuseppe; U.O. di Pneumologia
Milano, Italy
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ASST DI MONZA; U O Clinica Pneumologica
Monza, Italy
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A.O.U. Ospedali Riuniti Di Foggia-Ospedale D'avanzo; Malattie Dell'apparato Respiratorio IV
Foggia, Italy
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A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone
Catania, Italy
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A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
Siena, Italy
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Azienda Ospedaliera di Padova; Dip. Scienze Cardiologiche Toraciche Vascolari-UOC Pneumologia
Padova, Italy
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Vu Medisch Centrum; Afdeling Longziekten
Amsterdam, Netherlands
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Erasmus MC
Rotterdam, Netherlands
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University of Cape Town Lung Institute; Lung Clinical Research
Cape Town, South Africa
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Milpark Hospital
Parktown West, South Africa
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University of Stellenbosch; Respiratory Research
Parow, South Africa
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Hospital Universitari de Bellvitge ; Servicio de Neumologia
Hospitalet de Llobregat, Spain
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Hospital Universitario Marques de Valdecilla; Servicio de neumologia
Santander, Spain
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Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumolog a
Majadahonda, Spain
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Hospital Clinic I provincial; Servicio de Neumologia
Barcelona, Spain
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Hospital Ram n y Cajal;Servicio de Neumolog a
Madrid, Spain
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Hospital Universitario la Fe; Servicio de Neumologia
Valencia, Spain
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Ankara Uni Faculty of Medicine; Chest Diseases
Ankara, Turkey
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Uludag University; Pulmonology and Allergy Department
Bursa, Turkey
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Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari
Istanbul, Turkey
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Istanbul Universitesi Capa T p Fak ltesi; Gogus Hastal klar Anabilim dal
Istanbul, Turkey
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