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NCT02579603 · ClinicalTrials.gov registry record · Phase 4
Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 105
- Enrollment target
NCT02579603: Completed Phase 4 study, sponsored by Boehringer Ingelheim.
NCT02579603 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 105 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02579603, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 105 participants
- Enrollment target
Study Summary
This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone. A secondary objective is to assess the exposure based on PK trough concentration values to nintedanib either given alone or in combination with pirfenidone and to assess the exposure of pirfenidone when combined with nintedanib.
Primary Outcome
Percentage of patients with on-treatment gastrointestinal (GI) Adverse events (AEs) (SOC GI disorders) from baseline to week 12. On-treatment AEs were defined as AEs with an onset from the first dose of randomised treatment up to the last dose of randomised treatment (inclusive).
Interventions
- DRUG Pirfenidone
- DRUG Nintedanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2015-10-16 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 4 |
What the finished NCT02579603 record still lists
NCT02579603 is an interventional study that assigns participants to a tested intervention. The registered 105 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 (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Pirfenidone is the first listed.
NCT02579603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02579603 about?
NCT02579603 is a clinical study titled "Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF". This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone. A secondary objective is to assess the exposure based on PK trough concentration values to nintedanib either given alone or in combi...
What is the current status of trial NCT02579603?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 105 participants. The study started on 2015-10-16. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT02579603?
The interventions under investigation include: Pirfenidone (DRUG), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT02579603?
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 NCT02579603's enrollment target sits among peer trials
105 749th of 2000 higher than 1,247 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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