Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients
Public ClinicalTrials.gov record NCT01335464. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01335464
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 515 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2011
- Primary completion
- Sep 30, 2013
- Completion
- Sep 30, 2013
- Last update posted
- Jul 24, 2016
2011 – 2013
United States locations
- U.S. sites
- 24
- U.S. states
- 19
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1199.32.10007 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1199.32.10029 Boehringer Ingelheim Investigational Site | Jasper | Alabama | — | — |
| 1199.32.10013 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | — | — |
| 1199.32.10005 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1199.32.10022 Boehringer Ingelheim Investigational Site | Danbury | Connecticut | — | — |
| 1199.32.10025 Boehringer Ingelheim Investigational Site | Newark | Delaware | — | — |
| 1199.32.10023 Boehringer Ingelheim Investigational Site | Weston | Florida | — | — |
| 1199.32.10001 Boehringer Ingelheim Investigational Site | Council Bluffs | Iowa | — | — |
| 1199.32.10028 Boehringer Ingelheim Investigational Site | Wichita | Kansas | — | — |
| 1199.32.10016 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | — | — |
| 1199.32.10024 Boehringer Ingelheim Investigational Site | New Brunswich | New Jersey | — | — |
| 1199.32.10019 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1199.32.10004 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1199.32.10020 Boehringer Ingelheim Investigational Site | Portland | Oregon | — | — |
| 1199.32.10002 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | — | — |
| 1199.32.10033 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | — | — |
| 1199.32.10008 Boehringer Ingelheim Investigational Site | Providence | Rhode Island | — | — |
| 1199.32.10015 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | — | — |
| 1199.32.10034 Boehringer Ingelheim Investigational Site | Shelbyville | Tennessee | — | — |
| 1199.32.10009 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1199.32.10018 Boehringer Ingelheim Investigational Site | McKinney | Texas | — | — |
| 1199.32.10021 Boehringer Ingelheim Investigational Site | Falls Church | Virginia | — | — |
| 1199.32.10003 Boehringer Ingelheim Investigational Site | Lynchburg | Virginia | — | — |
| 1199.32.10038 Boehringer Ingelheim Investigational Site | Tacoma | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 74 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01335464, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 24, 2016 · Synced Sep 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01335464 live on ClinicalTrials.gov.