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Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:
A Twelve Week, Open-label, Randomised, Parallel-group Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Oral Nintedanib in Combination With Oral Pirfenidone, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Summary

This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone.

A secondary objective is to assess the exposure based on PK trough concentration values to nintedanib either given alone or in combination with pirfenidone and to assess the exposure of pirfenidone when combined with nintedanib.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02579603
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Completed
Phase Phase 4
Start date October 16, 2015
Completion date January 31, 2017
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