Trials / Completed
CompletedNCT01335464
Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 515 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | placebo | placebo matching BIBF1120, BID |
| DRUG | BIBF 1120 | BIBF1120 BID (twice daily) |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2011-04-14
- Last updated
- 2016-07-25
- Results posted
- 2015-02-13
Locations
98 sites across 13 countries: United States, Australia, Belgium, China, Czechia, France, Germany, India, Ireland, Israel, Italy, Japan, United Kingdom
Source: ClinicalTrials.gov record NCT01335464. Inclusion in this directory is not an endorsement.