At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 274 enrolled
Drug / intervention
Nintedanib +2 moredrug
Likely dose
Not stated in 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.
INSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function Impairment
In Brief
A Phase 3 clinical trial evaluating Nintedanib, Placebo, and 1 other intervention for Idiopathic Pulmonary Fibrosis. Completed, enrolled 274 participants across 85 sites in 13 countries.
Detailed Summary
To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesAustralia, Belgium, Canada, France, Germany, India, Italy, Japan, Mexico, South Korea, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartJun 2016
Primary CompletionDec 2017
Study CompletionApr 2018
TodayJul 2026
First PostedJun 16, 2016
Enrollment StartJun 30, 2016
Primary CompletionDec 19, 2017
Study CompletionApr 13, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.0 years ago
Interventions
Nintedanibdrug
Placebodrug
Sildenafildrug