Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005131-40 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirfenidone + Placebo | Placebo Comparator | Participants will receive pirfenidone along with placebo matched to sildenafil, orally, three times a day (TID) for 52 weeks. |
|
| Pirfenidone + Sildenafil | Experimental | Participants will receive pirfenidone along with sildenafil, orally, TID for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone | Drug | Pirfenidone will be given in the range of 1602 to 2403 milligram per day (mg/day), as 3 divided doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Progression, as Determined by Relevant Decline in 6 Minute Walk Distance (6MWD) of At Least (>=) 15 Percent (%) From Baseline, Respiratory-Related Non-Elective Hospitalization, or Death From Any Cause | Disease Progression defined as relative decline in 6-minute walking distance (6MWD) from baseline (defined as >25% from baseline or 15-25% from baseline associated with worsening oxygen saturation, worsening Borg score, or increased oxygen requirements), respiratory-related non-elective hospitalizations, or all-cause mortality. | Baseline up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Occurrence of Disease Progression | Disease Progression defined as relative decline in 6MWD from baseline (defined as >25% from baseline or 15-25% from baseline associated with worsening oxygen saturation, worsening Borg score, or increased oxygen requirements), respiratory-related non-elective hospitalizations, or all-cause mortality. | Baseline up to Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ULB Hôpital Erasme | Brussels | 1070 | Belgium | |||
| Cliniques Universitaires St-Luc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37391667 | Derived | Behr J, Nathan SD, Costabel U, Albera C, Wuyts WA, Glassberg MK, Haller H Jr, Alvaro G, Gilberg F, Samara K, Lancaster L. Efficacy and Safety of Pirfenidone in Advanced Versus Non-Advanced Idiopathic Pulmonary Fibrosis: Post-Hoc Analysis of Six Clinical Studies. Adv Ther. 2023 Sep;40(9):3937-3955. doi: 10.1007/s12325-023-02565-3. Epub 2023 Jun 30. | |
| 32822614 |
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Written informed consent for participation in the study was obtained before performing any study-specific screening tests or evaluations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pirfenidone+Sildenafil | Participants received pirfenidone along with sildenafil, orally, three times a day for 52 weeks. |
| FG001 | Pirfenidone+Placebo | Participants received pirfenidone along with placebo matched to sildenafil, orally, three times a day for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2017 | Sep 18, 2020 |
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|
| Placebo | Drug | Placebo matched with sildenafil. |
|
| Sildenafil | Drug | Sildenafil will be given as 20 mg, TID. |
|
|
| Time to Multiple Occurrence of Disease Progression Events | Disease Progression defined as relative decline in 6MWD from baseline (defined as >25% from baseline or 15-25% from baseline associated with worsening oxygen saturation, worsening Borg score, or increased oxygen requirements), respiratory-related non-elective hospitalizations, or all-cause mortality. In case participant had more than one event as described in the endpoint definition the second, third etc event was counted as well for the calculation of the endpoint. | Baseline up to Week 52 |
| Percentage of Participants With Decline From Baseline in 6-minute Walking Distance (6MWD) of >= 15% | Baseline up to Week 52 |
| Time to First Occurrence of Relevant ≥15% Decline From Baseline in 6-minute Walking Distance (6MWD) | Baseline up to Week 52 |
| Time to Respiratory-Related Non-Elective Hospitalization From Baseline to Week 52 | N.A. = non-calculable | Baseline up to Week 52 |
| Time to All-Cause Non-Elective Hospitalization | N.A. = non-calculable | Baseline up to Week 52 |
| Time to Death From Any Cause | Baseline up to Week 52 |
| Percentage of Participants With Lung Transplantation | Baseline up to Week 52 |
| Time to Respiratory-Related Death | Baseline up to Week 52 |
| Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Peak Tricuspid Regurgitation Velocity | Baseline, Week 52 |
| Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Pulmonary Artery Pressure (PAPs) | Baseline, Week 52 |
| Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Tricuspid Annular Plane Systolic Excursion (TAPSE) | Baseline, Week 52 |
| Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Right Ventricle Basal Diameter | Baseline, Week 52 |
| Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Inferior Vena Cava Diameter | Baseline, Week 52 |
| Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Left Ventricular Ejection Fraction (LVEF) | Baseline, Week 52 |
| Change From Baseline to Week 52 in Carbon Monoxide Diffusing Capacity/ Pulmonary Diffusing Capacity (DLCO) | Baseline, Week 52 |
| Change From Baseline to Week 52 in Forced Vital Capacity (FVC) | Baseline, Week 52 |
| Percentage of Participants by World Health Organization (WHO) Functional Class at Week 52 | The World Health Organisation (WHO) functional class system defines the severity of an participant's symptoms. Class II - Participants with Pulmonary Hypertension resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue breathlessness, fatigue (tiredness), or activities that can cause chest pain, dizziness or even black outs. Class III - Participants with Pulmonary Hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue breathlessness, fatigue (tiredness), or activities that can cause chest pain, dizziness or even black outs. Class IV - participants with pulmonary hypertension with inability to carry out any physical activity without symptoms. These participants manifest signs of right heart failure, breathlessness and /or fatigue, which may even be present at rest. Discomfort is increased by any physical activity. | Week 52 |
| Change From Baseline in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Level (pg/mL) at Week 52 | Baseline, Week 52 |
| St. George's Respiratory Questionnaire (SGRQ) Changes From Baseline at Week 52 | The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in participants with diseases of airways obstruction. Three component scores are calculated, where the higher the component result the worse the condition: Symptoms concerned with the effect of respiratory symptoms, their frequency and severity (range: 0-16.61) Activity concerned with activities that cause or are limited by breathlessness (range: 0-30.31) Impacts covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease (range: 0- 53.08) Total score summaries the impact of disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. | Baseline, Week 52 |
| University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) Changes From Baseline at Week 52 | The UCSD-SOBQ is a respiratory questionnaire and it assesses dyspnea associated with activities of daily living (ADL). Participants indicate severity of SOB on a 6-point scale in 21 ADL. Three additional questions ask about fear of harm from overexertion, limitations and fear caused by SOB. A total score ranges from 0 to 120, with higher scores indicating greater impairment. | Baseline, Week 52 |
| Change From Baseline in Distance Walked, 6-minute Walking Distance (6MWD) Test at Week 52 | Baseline up to Week 52 |
| Change From Baseline in Oxygen Requirements, 6-minute Walking Distance (6MWD) Test at Week 52 | Baseline up to Week 52 |
| Change From Baseline in Other 6-minute Walking Distance (6MWD) Parameters at Week 52 | Baseline up to Week 52 |
| Percentage of Participants With Adverse Events | Baseline up to Week 52 + 28 days |
| Borg Scale Result at the End of the Test at Week 52 | The Borg Scale rates participant's level of perceived exertion during any activity from 0-10, with 0 being no effort at all and 10 being maximal exertion. | Week 52 |
| Brussels |
| 1200 |
| Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| CHU UCL Mont-Godinne | Mont-godinne | 5530 | Belgium |
| Hotel Dieu Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| CHUM Hôpital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval) | Ste. Foy | Quebec | G1V 4G5 | Canada |
| Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN | Praha 4 - Krc | 140 59 | Czechia |
| Clinical Research Center (CRC), Faculty of Medicine, Alexandria University | Alexandria | 21131 | Egypt |
| Kasr El-Aini-Chest Unit; Department 3-Chest Unit | Cairo | 11562 | Egypt |
| Ain Shams University Hospital-Chest unit; Chest unit | Cairo | 11566 | Egypt |
| Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie | Coswig | 01640 | Germany |
| Klinik Donaustauf Zentrum für Pneumologie | Donaustauf | 93093 | Germany |
| Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie | Essen | 45239 | Germany |
| Klinikum Fulda gAG; Universitätsmedizin Marburg, Campus Fulda | Fulda | 36043 | Germany |
| Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie | Giessen | 35392 | Germany |
| Thoraxklinik Heidelberg gGmbH | Heidelberg | 69126 | Germany |
| Fachklinik für Lungenerkrankungen | Immenhausen | 34376 | Germany |
| Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V | München | 81377 | Germany |
| Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology | Athens | 115 27 | Greece |
| University General Hospital of Athens "Attikon", B' University Pulmonary Clinic | Chaïdári | 124 62 | Greece |
| University General Hospital of Heraklio, Pulmonary Clinic | Heraklio | 711 10 | Greece |
| Semmelweis Egyetem X; Pulmonologiai Klinika | Budapest | 1083 | Hungary |
| Orszagos Koranyi TBC es Pulmonologiai Intezet | Budapest | 1121 | Hungary |
| Soroka; Pulmonary Clinic | Beersheba | 8410101 | Israel |
| Carmel Medical Center; Pulmonary Institute | Haifa | 3436212 | Israel |
| Shaare Zedek Medical Center; Pulmonary Inst. | Jerusalem | 9103102 | Israel |
| Hadassah Medical Center; Pulmonary Institute | Jerusalem | 9112001 | Israel |
| Meir Medical Center; Pulmonary Dept | Kfar Saba | 4428164 | Israel |
| Beilinson Medical Center; Pulmonary Inst. | Petah Tikva | 4941492 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| A.O.U. Ospedali Riuniti Di Foggia-Ospedale D'avanzo; Malattie Dell'apparato Respiratorio IV | Foggia | Apulia | 71100 | Italy |
| Ospedale Morgagni-Pierantoni; U.O. Pneumologia | Forlì | Emilia-Romagna | 47121 | Italy |
| A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio | Modena | Emilia-Romagna | 41124 | Italy |
| Ospedale San Giuseppe; U.O. di Pneumologia | Milan | Lombardy | 20123 | Italy |
| ASST DI MONZA; U O Clinica Pneumologica | Monza | Lombardy | 20900 | Italy |
| A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone | Catania | Sicily | 95123 | Italy |
| A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare | Siena | Tuscany | 53100 | Italy |
| Azienda Ospedaliera di Padova; Dip. Scienze Cardiologiche Toraciche Vascolari-UOC Pneumologia | Padova | Veneto | 35128 | Italy |
| Vu Medisch Centrum; Afdeling Longziekten | Amsterdam | 1081 HV | Netherlands |
| Erasmus MC | Rotterdam | 3015 GD | Netherlands |
| University of Cape Town Lung Institute; Lung Clinical Research | Cape Town | 7700 | South Africa |
| Milpark Hospital | Parktown West | 2196 | South Africa |
| University of Stellenbosch; Respiratory Research | Parow | 7505 | South Africa |
| Hospital Universitari de Bellvitge ; Servicio de Neumologia | L'Hospitalet de Llobregat | Barcelona | 08097 | Spain |
| Hospital Universitario Marques de Valdecilla; Servicio de neumologia | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología | Majadahonda | Madrid | 28222 | Spain |
| Hospital Clinic I provincial; Servicio de Neumologia | Barcelona | 08036 | Spain |
| Hospital Universitario la Fe; Servicio de Neumologia | Valencia | 46009 | Spain |
| Ankara Uni Faculty of Medicine; Chest Diseases | Ankara | 06100 | Turkey (Türkiye) |
| Uludag University; Pulmonology and Allergy Department | Bursa | 16059 | Turkey (Türkiye) |
| Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari | Istanbul | 34020 | Turkey (Türkiye) |
| Istanbul Universitesi Capa Tıp Fakültesi; Gogus Hastalıkları Anabilim dalı | Istanbul | 34093 | Turkey (Türkiye) |
| Ege Universitesi Tıp Fakültesi; Gögüs Hastalıkları Bilim Dalı | Izmir | 35040 | Turkey (Türkiye) |
| Behr J, Nathan SD, Wuyts WA, Mogulkoc Bishop N, Bouros DE, Antoniou K, Guiot J, Kramer MR, Kirchgaessler KU, Bengus M, Gilberg F, Perjesi A, Harari S, Wells AU. Efficacy and safety of sildenafil added to pirfenidone in patients with advanced idiopathic pulmonary fibrosis and risk of pulmonary hypertension: a double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Respir Med. 2021 Jan;9(1):85-95. doi: 10.1016/S2213-2600(20)30356-8. Epub 2020 Aug 18. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
ITT Population -
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pirfenidone+Sildenafil | Participants received pirfenidone along with sildenafil, orally, three times a day for 52 weeks. |
| BG001 | Pirfenidone+Placebo | Participants received pirfenidone along with placebo matched to sildenafil, orally, three times a day for 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Disease Progression, as Determined by Relevant Decline in 6 Minute Walk Distance (6MWD) of At Least (>=) 15 Percent (%) From Baseline, Respiratory-Related Non-Elective Hospitalization, or Death From Any Cause | Disease Progression defined as relative decline in 6-minute walking distance (6MWD) from baseline (defined as >25% from baseline or 15-25% from baseline associated with worsening oxygen saturation, worsening Borg score, or increased oxygen requirements), respiratory-related non-elective hospitalizations, or all-cause mortality. | Participants with data available at week 52. | Posted | Number | Percentage of Participants | Baseline up to Week 52 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Occurrence of Disease Progression | Disease Progression defined as relative decline in 6MWD from baseline (defined as >25% from baseline or 15-25% from baseline associated with worsening oxygen saturation, worsening Borg score, or increased oxygen requirements), respiratory-related non-elective hospitalizations, or all-cause mortality. | Participants with data available at week 52. | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to Week 52 |
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| Secondary | Time to Multiple Occurrence of Disease Progression Events | Disease Progression defined as relative decline in 6MWD from baseline (defined as >25% from baseline or 15-25% from baseline associated with worsening oxygen saturation, worsening Borg score, or increased oxygen requirements), respiratory-related non-elective hospitalizations, or all-cause mortality. In case participant had more than one event as described in the endpoint definition the second, third etc event was counted as well for the calculation of the endpoint. | Participants with data available at week 52. | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to Week 52 |
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| Secondary | Percentage of Participants With Decline From Baseline in 6-minute Walking Distance (6MWD) of >= 15% | Participants with data available at week 52 to calculate a change from baseline. | Posted | Number | Percentage | Baseline up to Week 52 |
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| Secondary | Time to First Occurrence of Relevant ≥15% Decline From Baseline in 6-minute Walking Distance (6MWD) | Participants with data available at week 52 to calculate a change from baseline. | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to Week 52 |
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| Secondary | Time to Respiratory-Related Non-Elective Hospitalization From Baseline to Week 52 | N.A. = non-calculable | Participants with data available at week 52. | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to Week 52 |
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| Secondary | Time to All-Cause Non-Elective Hospitalization | N.A. = non-calculable | Participants with data available at week 52. | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to Week 52 |
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| Secondary | Time to Death From Any Cause | Participants with data available at week 52. | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to Week 52 |
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| Secondary | Percentage of Participants With Lung Transplantation | Participants with data available at week 52. | Posted | Number | Percentage | Baseline up to Week 52 |
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| Secondary | Time to Respiratory-Related Death | Participants with data available at week 52. | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Peak Tricuspid Regurgitation Velocity | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | m/s | Baseline, Week 52 |
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| Secondary | Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Pulmonary Artery Pressure (PAPs) | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 52 |
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| Secondary | Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Tricuspid Annular Plane Systolic Excursion (TAPSE) | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | cm | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Right Ventricle Basal Diameter | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | cm | Baseline, Week 52 |
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| Secondary | Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Inferior Vena Cava Diameter | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | cm | Baseline, Week 52 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Left Ventricular Ejection Fraction (LVEF) | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | Percentage | Baseline, Week 52 |
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| Secondary | Change From Baseline to Week 52 in Carbon Monoxide Diffusing Capacity/ Pulmonary Diffusing Capacity (DLCO) | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | Percentage Predicted | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 in Forced Vital Capacity (FVC) | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | Percentage Predicted | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants by World Health Organization (WHO) Functional Class at Week 52 | The World Health Organisation (WHO) functional class system defines the severity of an participant's symptoms. Class II - Participants with Pulmonary Hypertension resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue breathlessness, fatigue (tiredness), or activities that can cause chest pain, dizziness or even black outs. Class III - Participants with Pulmonary Hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue breathlessness, fatigue (tiredness), or activities that can cause chest pain, dizziness or even black outs. Class IV - participants with pulmonary hypertension with inability to carry out any physical activity without symptoms. These participants manifest signs of right heart failure, breathlessness and /or fatigue, which may even be present at rest. Discomfort is increased by any physical activity. | Participants with data available at week 52. | Posted | Number | Percentage | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Level (pg/mL) at Week 52 | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | pg/mL) | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | St. George's Respiratory Questionnaire (SGRQ) Changes From Baseline at Week 52 | The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in participants with diseases of airways obstruction. Three component scores are calculated, where the higher the component result the worse the condition: Symptoms concerned with the effect of respiratory symptoms, their frequency and severity (range: 0-16.61) Activity concerned with activities that cause or are limited by breathlessness (range: 0-30.31) Impacts covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease (range: 0- 53.08) Total score summaries the impact of disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 52 |
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| Secondary | University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) Changes From Baseline at Week 52 | The UCSD-SOBQ is a respiratory questionnaire and it assesses dyspnea associated with activities of daily living (ADL). Participants indicate severity of SOB on a 6-point scale in 21 ADL. Three additional questions ask about fear of harm from overexertion, limitations and fear caused by SOB. A total score ranges from 0 to 120, with higher scores indicating greater impairment. | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | Points on scale | Baseline, Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Distance Walked, 6-minute Walking Distance (6MWD) Test at Week 52 | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | meters | Baseline up to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Oxygen Requirements, 6-minute Walking Distance (6MWD) Test at Week 52 | Posted | Mean | Standard Deviation | L | Baseline up to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Other 6-minute Walking Distance (6MWD) Parameters at Week 52 | Participants with data available at week 52 to calculate a change from baseline. | Posted | Mean | Standard Deviation | Percentage | Baseline up to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events | Participants with AEs that started or worsened on or after first intake of randomized treatment until last positive dose + 28 days | Posted | Number | Percentage | Baseline up to Week 52 + 28 days |
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| Secondary | Borg Scale Result at the End of the Test at Week 52 | The Borg Scale rates participant's level of perceived exertion during any activity from 0-10, with 0 being no effort at all and 10 being maximal exertion. | Participants with data available at week 52. | Posted | Mean | Standard Deviation | Points on Scale | Week 52 |
|
|
From baseline to primary data cut-off (up to 2 years 7 months). The safety data includes DBP and SFU up to 11-Nov-2019.
Total # of Deaths (all causes n= 64) represent deaths occurring during Double blind treatment period+4 week FU+additional safety follow up to the database snapshot of 11-Nov-2019.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pirfenidone+Sildenafil | Participants received pirfenidone along with sildenafil, orally, three times a day for 52 weeks. | 28 | 88 | 54 | 88 | 53 | 88 |
| EG001 | Pirfenidone+Placebo | Participants received pirfenidone along with placebo matched to sildenafil, orally, three times a day for 52 weeks. | 36 | 89 | 55 | 89 | 58 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Blindness transient | Eye disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.1 | Systematic Assessment |
| |
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.1 | Systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Urinary bladder polyp | Renal and urinary disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Lung transplant | Surgical and medical procedures | MedDRA version 22.1 | Systematic Assessment |
| |
| Cryoglobulinaemia | Vascular disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Dry gangrene | Vascular disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA version 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 22.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2019 | Oct 20, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C093844 | pirfenidone |
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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