Trials / Completed
CompletedNCT04093024
A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)
A Double Blind, Randomised, Placebo-controlled Trial to Evaluate the Dose-exposure and Safety of Nintedanib Per os on Top of Standard of Care for 24 Weeks, Followed by Open Label Treatment With Nintedanib of Variable Duration, in Children and Adolescents (6 to 17 Year-old) With Clinically Significant Fibrosing Interstitial Lung Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nintedanib | Capsule |
| DRUG | Placebo | Capsule |
Timeline
- Start date
- 2019-12-03
- Primary completion
- 2022-05-24
- Completion
- 2022-05-24
- First posted
- 2019-09-17
- Last updated
- 2024-07-09
- Results posted
- 2023-01-31
Locations
43 sites across 21 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Greece, Hungary, Italy, Mexico, Norway, Poland, Portugal, Russia, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04093024. Inclusion in this directory is not an endorsement.