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 ...

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

Reference Study ID Number: MA29957 ...

University of Stellenbosch; Respiratory Research
Parow, South Africa