NCT 02951429.

Trial name or title	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
Methods	Phase IIb, randomised parallel‐group controlled trial
Participants	Participants with advanced IPF and risk of Group 3 pulmonary hypertension (PH)
Interventions	Pirfenidone plus sildenafil versus pirfenidone plus placebo
Outcomes	Percentage of participants with disease progression, as determined by relevant decline in 6MWD of at least ≥ 15 percent from baseline, respiratory‐related non‐elective hospitalisation, or death from any cause Progression‐free survival 6MWD Time to all‐cause non‐elective hospitalisation Time to death from any cause Time to respiratory‐related death Percentage of participants with lung transplantation Peak tricuspid regurgitation velocity PAP FVC FEV1 FEV1/FVC ratio CO diffusing capacity/pulmonary diffusing capacity (DCLO) Change from baseline to weeks 6, 12, 26, 39, and 52 in SpO2 at rest and during the 6MWD Perceived exertion, as assessed by BORG rating of perceived exertion scale Percentage of participants by WHO functional class Change from baseline to weeks 12, 26, 39, and 52 in dyspnoea, as assessed by the University of California San Diego shortness of breath questionnaire (UCDS SOBQ) Change from baseline to weeks 12, 26, 39, and 52 in health‐related quality of life (hrqol), as assessed by the SGRQ Change from baseline to weeks 12, 26, and 52 in NT‐proBNP level at baseline, weeks 12, 26, and 52 Adverse events and serious adverse events Measured at 52 weeks
Starting date	Currently recruiting
Contact information	global‐roche‐genentech‐trials@gene.com
Notes	ClinicalTrials.gov Identifier: NCT02951429 Currently recruiting