Trials / Completed
CompletedNCT02788474
Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment
A 12-week, Double Blind, Randomised, Placebo Controlled, Parallel Group Trial Followed by a Single Active Arm Phase of 40 Weeks Evaluating the Effect of Oral Nintedanib 150 mg Twice Daily on Change in Biomarkers of Extracellular Matrix (ECM) Turnover in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Limited Forced Vital Capacity (FVC) Impairment.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 347 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
Identifying biomarkers to predict the clinical course and benefits of therapy early in the course of the disease remains one of the most urgent and relevant challenges to improve overall patient management, to prevent treatment delay or overtreatment. This study is conducted to examine the effect of nintedanib treatment on change in biomarkers indicative of extracellular matrix turnover which have been shown recently to correlate with disease progression. This study further aims to confirm the association of biomarker course during the first three months of treatment and disease progression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nintedanib | |
| DRUG | placebo |
Timeline
- Start date
- 2016-06-09
- Primary completion
- 2017-08-04
- Completion
- 2018-06-08
- First posted
- 2016-06-02
- Last updated
- 2023-12-21
- Results posted
- 2019-08-06
Locations
86 sites across 13 countries: United States, Australia, Belgium, Czechia, Finland, France, Germany, Hungary, Japan, Poland, South Korea, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02788474. Inclusion in this directory is not an endorsement.