A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.

Trial Profile

A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.

Active, no longer recruiting
Phase of Trial: Phase IV

Latest Information Update: 28 Jun 2017

At a glance

  • Drugs Nintedanib (Primary)
  • Indications Idiopathic pulmonary fibrosis
  • Focus Biomarker; Pharmacodynamics
  • Acronyms PROFILE
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 22 Jun 2017 Status changed from recruiting to active, no longer recruiting.
    • 16 May 2017 Planned primary completion date changed from 8 Jun 2017 to 7 Aug 2017.
    • 08 May 2017 Planned End Date changed from 11 Apr 2018 to 1 Jun 2018.
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