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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: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01979952 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 113 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Relative change from baseline in HRCT QLF score at 6 months was calculated as the difference of the QLF score at month 6 minus the QLF score at baseline divided by the baseline QLF score. The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline
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 |
What the finished NCT01979952 record still lists
NCT01979952 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT01979952 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01979952's enrollment target sits among peer trials
113 1651st of 2000 higher than 349 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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