CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 89 enrolled
Drug / intervention
Nintedanib +1 moredrug
Likely dose
Nintedanib 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02598193
NCT02598193Phase 4Completed
CompareCT.gov

An Exploratory Multicenter, Open-Label, Single Arm Study of the Safety and Tolerability of Pirfenidone (Esbriet®) in Combination With Nintedanib (Ofev®) in Patients With Idiopathic Pulmonary Fibrosis

Hoffmann-La Roche·interventional·Posted Nov 5, 2015·Updated Jun 13, 2018

In Brief

A Phase 4 clinical trial evaluating Nintedanib and Pirfenidone for Idiopathic Pulmonary Fibrosis. Completed, enrolled 89 participants across 38 sites in 8 countries.

Detailed Summary

This clinical study will evaluate the safety and tolerability of combination treatment of nintedanib and pirfenidone in participants with IPF. Eligible participants must have received pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the study as a combination treatment for IPF for 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesCanada, Denmark, France, Germany, Italy, Netherlands, Spain, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 5, 2015
Enrollment StartJan 14, 2016
Primary CompletionMay 16, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.7 years ago

Interventions

Nintedanibdrug

Participants with IPF will receive nintedanib at the 200-300 mg/day dose up to 24 weeks.

Pirfenidonedrug

Participants with IPF will receive pirfenidone at 1602-2403 mg/day dose up to 24 weeks.