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

PHASE2CompletedINTERVENTIONAL
Enrollment

177

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

September 26, 2019

Study Completion Date

August 22, 2020

Conditions
Idiopathic Pulmonary Fibrosis
Interventions
DRUG

Pirfenidone

Pirfenidone will be given in the range of 1602 to 2403 milligram per day (mg/day), as 3 divided doses.

DRUG

Placebo

Placebo matched with sildenafil.

DRUG

Sildenafil

Sildenafil will be given as 20 mg, TID.

Trial Locations (56)

1070

ULB Hôpital Erasme, Brussels

1083

Semmelweis Egyetem X; Pulmonologiai Klinika, Budapest

1121

Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest

1200

Cliniques Universitaires St-Luc, Brussels

2196

Milpark Hospital, Parktown West

2650

UZ Antwerpen, Edegem

3000

UZ Leuven Gasthuisberg, Leuven

4000

CHU Sart-Tilman, Liège

5530

CHU UCL Mont-Godinne, Mont-godinne

7505

University of Stellenbosch; Respiratory Research, Parow

7700

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

11562

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

11566

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

16059

Uludag University; Pulmonology and Allergy Department, Bursa

20123

Ospedale San Giuseppe; U.O. di Pneumologia, Milan

20900

ASST DI MONZA; U O Clinica Pneumologica, Monza

21131

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

28222

Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología, Majadahonda

34020

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

34093

Istanbul Universitesi Capa Tıp Fakültesi; Gogus Hastalıkları Anabilim dalı, Istanbul

34376

Fachklinik für Lungenerkrankungen, Immenhausen

35040

Ege Universitesi Tıp Fakültesi; Gögüs Hastalıkları Bilim Dalı, Izmir

35128

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

35392

Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie, Giessen

36043

Klinikum Fulda gAG; Universitätsmedizin Marburg, Campus Fulda, Fulda

39008

Hospital Universitario Marques de Valdecilla; Servicio de neumologia, Santander

41124

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

45239

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

46009

Hospital Universitario la Fe; Servicio de Neumologia, Valencia

47121

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

53100

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

69126

Thoraxklinik Heidelberg gGmbH, Heidelberg

71100

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

81377

Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V, München

93093

Klinik Donaustauf Zentrum für Pneumologie, Donaustauf

95123

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

3436212

Carmel Medical Center; Pulmonary Institute, Haifa

4428164

Meir Medical Center; Pulmonary Dept, Kfar Saba

4941492

Beilinson Medical Center; Pulmonary Inst., Petah Tikva

7610001

Kaplan Medical Center, Rehovot

8410101

Soroka; Pulmonary Clinic, Beersheba

9103102

Shaare Zedek Medical Center; Pulmonary Inst., Jerusalem

9112001

Hadassah Medical Center; Pulmonary Institute, Jerusalem

K7L 2V7

Hotel Dieu Hospital, Kingston

H2L 4M1

CHUM Hôpital Notre-Dame, Montreal

G1V 4G5

Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval), Ste. Foy

140 59

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

01640

Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie, Coswig

115 27

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

124 62

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

711 10

University General Hospital of Heraklio, Pulmonary Clinic, Heraklio

1081 HV

Vu Medisch Centrum; Afdeling Longziekten, Amsterdam

3015 GD

Erasmus MC, Rotterdam

08097

Hospital Universitari de Bellvitge ; Servicio de Neumologia, L'Hospitalet de Llobregat

08036

Hospital Clinic I provincial; Servicio de Neumologia, Barcelona

06100

Ankara Uni Faculty of Medicine; Chest Diseases, Ankara

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02951429 - 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 | Biotech Hunter | Biotech Hunter