Trials / Completed
CompletedNCT03313180
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 444 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nintedanib | Administered twice daily |
Timeline
- Start date
- 2017-11-27
- Primary completion
- 2023-01-25
- Completion
- 2023-01-25
- First posted
- 2017-10-18
- Last updated
- 2024-02-20
- Results posted
- 2024-02-20
Locations
159 sites across 30 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03313180. Inclusion in this directory is not an endorsement.