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NCT01979952 · ClinicalTrials.gov registry record · Phase 3
Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 113
- Enrollment target
NCT01979952 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 113 participants.
The verdict
NCT01979952, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 113 participants
- Enrollment target
Study Summary
This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing the effect of nintedanib 150mg bis in die (BID twice daily) on the progression of IPF measured by using High Resolution Computerized Tomography(HRCT), lung function, functional component (6MWT), biomarkers, and PRO component (PROs) with continued treatment and assessments for up to 18 months.
Interventions
- DRUG Matching Placebo
- DRUG Nintedanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2013-11-26 |
| Est. Completion | 2016-10-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01979952
The ClinicalTrials.gov registry entry for NCT01979952 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 113 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 Matching Placebo is the first listed.
NCT01979952 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01979952 about?
NCT01979952 is a clinical study titled "Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)". This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing the effect of nintedanib 150mg bis in die (BID twice daily) on the progression of IPF measured by usi...
What is the current status of trial NCT01979952?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 113 participants. The study started on 2013-11-26. Estimated completion is 2016-10-27.
What interventions are being tested in trial NCT01979952?
The interventions under investigation include: Matching Placebo (DRUG), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT01979952?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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