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NCT02788474 · ClinicalTrials.gov registry record · Phase 4
Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 347
- Enrollment target
NCT02788474: Completed Phase 4 study, sponsored by Boehringer Ingelheim.
NCT02788474 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 347 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02788474, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 347 participants
- Enrollment target
Study 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.
Primary Outcome
The rate of change (slope) in blood C-reactive protein degraded by matrix metalloproteinase-1/8 (CRPM) from baseline to week 12 is presented. The mean presented is the adjusted rate based on a random coefficient regression (CRPM log 10 transformed) with fixed effects for gender, age, height and random effect of patient specific intercept and time.
Interventions
- DRUG placebo
- DRUG nintedanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2016-06-09 |
| Est. Completion | 2018-06-08 |
| Phase | Phase 4 |
What the finished NCT02788474 record still lists
NCT02788474 is an interventional study that assigns participants to a tested intervention. The registered 347 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02788474 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02788474 about?
NCT02788474 is a clinical study titled "Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment". 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...
What is the current status of trial NCT02788474?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 347 participants. The study started on 2016-06-09. Estimated completion is 2018-06-08.
What interventions are being tested in trial NCT02788474?
The interventions under investigation include: placebo (DRUG), nintedanib (DRUG).
Who is sponsoring clinical trial NCT02788474?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02788474's enrollment target sits among peer trials
347 241st of 2000 higher than 1,759 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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