Last updated on September 2018

Efficacy Safety and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Risk 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 risk 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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Reference Study ID Number: MA29957 ...

Cliniques Universitaires St-Luc
Bruxelles, Belgium

Reference Study ID Number: MA29957 ...

UZ Antwerpen
Edegem, Belgium

Reference Study ID Number: MA29957 ...

UZ Leuven Gasthuisberg
Leuven, Belgium

Reference Study ID Number: MA29957 ...

CHU UCL Mont-Godinne
Mont-godinne, Belgium

Reference Study ID Number: MA29957 ...

Hotel Dieu Hospital
Kingston, ON Canada

Reference Study ID Number: MA29957 ...

CHUM H pital Notre-Dame
Montreal, QC Canada

Reference Study ID Number: MA29957 ...

Institut universitaire de cardiologie et de pneumologie de Qu bec (H pital Laval)
Ste. Foy, QC Canada

Reference Study ID Number: MA29957 ...

Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN
Praha 4 - Krc, Czechia

Reference Study ID Number: MA29957 ...

Clinical Research Center (CRC), Faculty of Medicine, Alexandria University
Alexandria, Egypt

Reference Study ID Number: MA29957 ...

Kasr El-Aini-Chest Unit; Department 3-Chest Unit
Cairo, Egypt

Reference Study ID Number: MA29957 ...

Ain Shams University Hospital-Chest unit; Chest unit
Cairo, Egypt

Reference Study ID Number: MA29957 ...

Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gef chirurgie
Coswig, Germany

Reference Study ID Number: MA29957 ...

Klinik Donaustauf Zentrum f r Pneumologie
Donaustauf, Germany

Reference Study ID Number: MA29957 ...

Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
Essen, Germany

Reference Study ID Number: MA29957 ...

Klinikum Fulda gAG; Universit tsmedizin Marburg, Campus Fulda
Fulda, Germany

Reference Study ID Number: MA29957 ...

Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany

Reference Study ID Number: MA29957 ...

Fachklinik f r Lungenerkrankungen
Immenhausen, Germany

Reference Study ID Number: MA29957 ...

Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology
Athens, Greece

Reference Study ID Number: MA29957 ...

University General Hospital of Athens "Attikon", B' University Pulmonary Clinic
Chaidari, Greece

Reference Study ID Number: MA29957 ...

University General Hospital of Heraklio, Pulmonary Clinic
Heraklio, Greece

Reference Study ID Number: MA29957 ...

Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, Hungary

Reference Study ID Number: MA29957 ...

Semmelweis Egyetem X; Pulmonologiai Klinika
Budapest, Hungary

Reference Study ID Number: MA29957 ...

Soroka; Pulmonary Clinic
Beer Sheba, Israel

Reference Study ID Number: MA29957 ...

Carmel Medical Center; Pulmonary Institute
Haifa, Israel

Reference Study ID Number: MA29957 ...

Shaare Zedek Medical Center; Pulmonary Inst.
Jerusalem, Israel

Reference Study ID Number: MA29957 ...

Hadassah Medical Center; Pulmonary Institute
Jerusalem, Israel

Reference Study ID Number: MA29957 ...

Meir Medical Center; Pulmonary Dept
Kfar Saba, Israel

Reference Study ID Number: MA29957 ...

Beilinson Medical Center; Pulmonary Inst.
Petach Tikva, Israel

Reference Study ID Number: MA29957 ...

Kaplan Medical Center
Rehovot, Israel

Reference Study ID Number: MA29957 ...

A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio
Modena, Italy

Reference Study ID Number: MA29957 ...

Ospedale San Giuseppe; U.O. di Pneumologia
Milano, Italy

Reference Study ID Number: MA29957 ...

ASST DI MONZA; U O Clinica Pneumologica
Monza, Italy

Reference Study ID Number: MA29957 ...

A.O.U. Ospedali Riuniti Di Foggia-Ospedale D'avanzo; Malattie Dell'apparato Respiratorio IV
Foggia, Italy

Reference Study ID Number: MA29957 ...

A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone
Catania, Italy

Reference Study ID Number: MA29957 ...

A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
Siena, Italy

Reference Study ID Number: MA29957 ...

Azienda Ospedaliera di Padova; Dip. Scienze Cardiologiche Toraciche Vascolari-UOC Pneumologia
Padova, Italy

Reference Study ID Number: MA29957 ...

Vu Medisch Centrum; Afdeling Longziekten
Amsterdam, Netherlands

Reference Study ID Number: MA29957 ...

Erasmus MC
Rotterdam, Netherlands

Reference Study ID Number: MA29957 ...

University of Cape Town Lung Institute; Lung Clinical Research
Cape Town, South Africa

Reference Study ID Number: MA29957 ...

Milpark Hospital
Parktown West, South Africa

Reference Study ID Number: MA29957 ...

University of Stellenbosch; Respiratory Research
Parow, South Africa

Reference Study ID Number: MA29957 ...

Hospital Universitari de Bellvitge ; Servicio de Neumologia
Hospitalet de Llobregat, Spain

Reference Study ID Number: MA29957 ...

Hospital Universitario Marques de Valdecilla; Servicio de neumologia
Santander, Spain

Reference Study ID Number: MA29957 ...

Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumolog a
Majadahonda, Spain

Reference Study ID Number: MA29957 ...

Hospital Clinic I provincial; Servicio de Neumologia
Barcelona, Spain

Reference Study ID Number: MA29957 ...

Hospital Ram n y Cajal;Servicio de Neumolog a
Madrid, Spain

Reference Study ID Number: MA29957 ...

Hospital Universitario la Fe; Servicio de Neumologia
Valencia, Spain

Reference Study ID Number: MA29957 ...

Ankara Uni Faculty of Medicine; Chest Diseases
Ankara, Turkey

Reference Study ID Number: MA29957 ...

Uludag University; Pulmonology and Allergy Department
Bursa, Turkey

Reference Study ID Number: MA29957 ...

Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari
Istanbul, Turkey

Reference Study ID Number: MA29957 ...

Istanbul Universitesi Capa T p Fak ltesi; Gogus Hastal klar Anabilim dal
Istanbul, Turkey

Reference Study ID Number: MA29957 ...

ULB H pital Erasme
Brussels, Belgium

Reference Study ID Number: MA29957 ...

CHU Sart-Tilman
Liège, Belgium

Reference Study ID Number: MA29957 ...

Universit tsklinikum Standort Gie en Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie
Gießen, Germany

Reference Study ID Number: MA29957 ...

Klinikum der Universit t M nchen; Campus Gro hadern; Med. Klinik und Poliklinik V
München, Germany

Reference Study ID Number: MA29957 ...

Ospedale Morgagni-Pierantoni; U.O. Pneumologia
Forlì, Italy