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A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients With Advanced Idiopathic Pulmonary Fibrosis and Risk of Group 3 Pulmonary Hypertension

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A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients With Advanced Idiopathic Pulmonary Fibrosis and Risk of Group 3 Pulmonary Hypertension

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Jul 2023

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At a glance

  • Drugs Pirfenidone (Primary) ; Sildenafil (Primary)
  • Indications Idiopathic pulmonary fibrosis
  • Focus Therapeutic Use
  • Acronyms SP-IPF
  • Sponsors Roche

    • Most Recent Events

    • 30 Jun 2023 Results of pooled analysis (from studies ASCEND (NCT01366209), CAPACITY 004 (NCT00287716), CAPACITY 006 (NCT00287729), RECAP (NCT00662038), PASSPORT (NCT02699879), and SP-IPF (NCT02951429)published in the Advances in Therapy
    • 19 May 2021 Results (n=144) of subgroup analysis assessing baseline characteristics and primary endpoint results of patients with and without RHC as well as normal or abnormal NT-proBNP levels at baseline presented at the 117th International Conference of the American Thoracic Society
    • 26 Oct 2020 The trial has been completed in Belgium and Germany (Global End Date: 22 Aug 2022), according to European Clinical Trials Database.

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