Trial · 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

NCT02951429, Phase 2, Completed, Hoffmann-La Roche; results first posted 2020-11-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT02951429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02951429

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT02951429
Status: Completed
Phases: Phase 2
Enrollment: 177 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: Pirfenidone, Placebo, Sildenafil
First posted: 2016-11-01
Last updated: 2020-11-12
Other registries' IDs: eudract:2015-005131-40
Results first posted: 2020-11-12

Source ClinicalTrials.gov

Registered outcomes27

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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	Baseline up to Week 52	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.
Secondary	Time to First Occurrence of Disease Progression	Baseline up to Week 52	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.
Secondary	Time to Multiple Occurrence of Disease Progression Events	Baseline up to Week 52	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.
Secondary	Percentage of Participants With Decline From Baseline in 6-minute Walking Distance (6MWD) of >= 15%	Baseline up to Week 52
Secondary	Time to First Occurrence of Relevant ≥15% Decline From Baseline in 6-minute Walking Distance (6MWD)	Baseline up to Week 52
Secondary	Time to Respiratory-Related Non-Elective Hospitalization From Baseline to Week 52	Baseline up to Week 52	N.A. = non-calculable
Secondary	Time to All-Cause Non-Elective Hospitalization	Baseline up to Week 52	N.A. = non-calculable
Secondary	Time to Death From Any Cause	Baseline up to Week 52
Secondary	Percentage of Participants With Lung Transplantation	Baseline up to Week 52
Secondary	Time to Respiratory-Related Death	Baseline up to Week 52

1 to 10 of 27Source ClinicalTrials.gov

See all 27 registered outcomes

Outcomes27

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
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	Baseline up to Week 52	Participants with data available at week 52.	Percentage of Participants	NUMBER
SECONDARY	Time to First Occurrence of Disease Progression	Baseline up to Week 52	Participants with data available at week 52.	Weeks	MEDIAN
SECONDARY	Time to Multiple Occurrence of Disease Progression Events	Baseline up to Week 52	Participants with data available at week 52.	Weeks	MEDIAN
SECONDARY	Percentage of Participants With Decline From Baseline in 6-minute Walking Distance (6MWD) of >= 15%	Baseline up to Week 52	Participants with data available at week 52 to calculate a change from baseline.	Percentage	NUMBER
SECONDARY	Time to First Occurrence of Relevant ≥15% Decline From Baseline in 6-minute Walking Distance (6MWD)	Baseline up to Week 52	Participants with data available at week 52 to calculate a change from baseline.	Weeks	MEDIAN
SECONDARY	Time to Respiratory-Related Non-Elective Hospitalization From Baseline to Week 52	Baseline up to Week 52	Participants with data available at week 52.	Weeks	MEDIAN
SECONDARY	Time to All-Cause Non-Elective Hospitalization	Baseline up to Week 52	Participants with data available at week 52.	Weeks	MEDIAN
SECONDARY	Time to Death From Any Cause	Baseline up to Week 52	Participants with data available at week 52.	Weeks	MEDIAN
SECONDARY	Percentage of Participants With Lung Transplantation	Baseline up to Week 52	Participants with data available at week 52.	Percentage	NUMBER
SECONDARY	Time to Respiratory-Related Death	Baseline up to Week 52	Participants with data available at week 52.	Weeks	MEDIAN

1 to 10 of 27Source ClinicalTrials.gov

See all 27 outcomes

Results by group70

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
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	Pirfenidone+Sildenafil	72.7		Percentage of Participants
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	Pirfenidone+Placebo	69.7		Percentage of Participants
Time to First Occurrence of Disease Progression	Pirfenidone+Sildenafil	26.00	95% Confidence Interval 20.57 to 38.14	Weeks
Time to First Occurrence of Disease Progression	Pirfenidone+Placebo	25.43	95% Confidence Interval 13.00 to 37.71	Weeks
Time to Multiple Occurrence of Disease Progression Events	Pirfenidone+Sildenafil	20.57	95% Confidence Interval 13.14 to 26.43	Weeks
Time to Multiple Occurrence of Disease Progression Events	Pirfenidone+Placebo	13.29	95% Confidence Interval 12.71 to 23.29	Weeks
Percentage of Participants With Decline From Baseline in 6-minute Walking Distance (6MWD) of >= 15%	Pirfenidone+Sildenafil	53.4		Percentage
Percentage of Participants With Decline From Baseline in 6-minute Walking Distance (6MWD) of >= 15%	Pirfenidone+Placebo	50.6		Percentage
Time to First Occurrence of Relevant ≥15% Decline From Baseline in 6-minute Walking Distance (6MWD)	Pirfenidone+Sildenafil	39.00	95% Confidence Interval 27.86 to 52.14	Weeks
Time to First Occurrence of Relevant ≥15% Decline From Baseline in 6-minute Walking Distance (6MWD)	Pirfenidone+Placebo	38.71	95% Confidence Interval 25.14 to 52.57	Weeks

1 to 10 of 70Source ClinicalTrials.gov

See all 70 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pirfenidone+Sildenafil	88
Overall Study	STARTED	Pirfenidone+Placebo	89
Overall Study	COMPLETED	Pirfenidone+Sildenafil	16
Overall Study	COMPLETED	Pirfenidone+Placebo	6
Overall Study	NOT COMPLETED	Pirfenidone+Sildenafil	72
Overall Study	NOT COMPLETED	Pirfenidone+Placebo	83

Source ClinicalTrials.gov

Adverse events178

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Pirfenidone+Sildenafil	11	88	15
other	Diarrhoea	Gastrointestinal disorders	Pirfenidone+Placebo	2	89	2
other	Vomiting	Gastrointestinal disorders	Pirfenidone+Sildenafil	5	88	5
other	Vomiting	Gastrointestinal disorders	Pirfenidone+Placebo	3	89	3
other	Fatigue	General disorders	Pirfenidone+Sildenafil	8	88	8
other	Fatigue	General disorders	Pirfenidone+Placebo	6	89	6
other	Oedema peripheral	General disorders	Pirfenidone+Sildenafil	3	88	4
other	Oedema peripheral	General disorders	Pirfenidone+Placebo	5	89	5
other	Bronchitis	Infections and infestations	Pirfenidone+Sildenafil	6	88	6
other	Bronchitis	Infections and infestations	Pirfenidone+Placebo	9	89	15

1 to 10 of 178Source ClinicalTrials.gov

See all 178 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pirfenidone+Sildenafil	28	88
Total, all-cause mortality	Pirfenidone+Placebo	36	89
Total, other adverse events	Pirfenidone+Sildenafil	53	88
Total, other adverse events	Pirfenidone+Placebo	58	89
Total, serious adverse events	Pirfenidone+Sildenafil	54	88
Total, serious adverse events	Pirfenidone+Placebo	55	89

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32822614	DERIVED	PubMed
37391667	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pirfenidone+Sildenafil vs Pirfenidone+Placebo: deaths from any cause	Trial comparisons
Pirfenidone+Sildenafil vs Pirfenidone+Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02951429

GET https://conductscience.org/api/trials/v1/NCT02951429/registered?page=2

API reference For AI assistants