At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 105 enrolled
Drug / intervention
Nintedanib +1 moredrug
Likely dose
Nintedanib 150mgfrom 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.
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)
In Brief
A Phase 4 clinical trial evaluating Nintedanib and Pirfenidone for Idiopathic Pulmonary Fibrosis. Completed, enrolled 105 participants across 23 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesCanada, France, Germany, Italy, Netherlands, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartOct 2015
First PostedOct 2015
Primary CompletionJan 2017
Study CompletionJan 2017
TodayJul 2026
First PostedOct 19, 2015
Enrollment StartOct 16, 2015
Primary CompletionJan 3, 2017
Study CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.7 years ago
Interventions
Nintedanibdrug
Nintedanib 150mg bid
Pirfenidonedrug