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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 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 105 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02579603
The ClinicalTrials.gov registry entry for NCT02579603 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pirfenidone is the first listed.
NCT02579603 reports 0 study locations.
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.
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