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NCT01335477 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 551
- Enrollment target
NCT01335477: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01335477 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 551 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01335477, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 551 participants
- Enrollment target
Study Summary
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate. In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo. Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data. Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.
Primary Outcome
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.
Interventions
- DRUG placebo
- DRUG BIBF 1120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 551 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01335477 record still lists
NCT01335477 is an interventional study that assigns participants to a tested intervention. The registered 551 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 (29% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01335477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01335477 about?
NCT01335477 is a clinical study titled "Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II". Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate. In a large P...
What is the current status of trial NCT01335477?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 551 participants. The study started on 2011-05. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01335477?
The interventions under investigation include: placebo (DRUG), BIBF 1120 (DRUG).
Who is sponsoring clinical trial NCT01335477?
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 NCT01335477's enrollment target sits among peer trials
551 680th of 2000 higher than 1,321 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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