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Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT02598193 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2018-06-13

Study results available
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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.

Conditions

Interventions

DRUG

Nintedanib

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

DRUG

Pirfenidone

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-14
Primary Completion
2017-05-16
Completion
2017-05-16
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02598193 on ClinicalTrials.gov