NCT00514683

Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis

A 12 Month, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of BIBF 1120 Administered at Oral Doses of 50 mg qd, 50 mg Bid, 100 mg Bid and 150 mg Bid on Forced Vital Capacity Decline During One Year, in Patients With Idiopathic Pulmonary Fibrosis, With Optional Active Treatment Extension Until Last Patient Out.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 432 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis. The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC). As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy

Conditions

• Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	low dose BIBF1120 once daily	low dose BIBF1120 once daily
DRUG	low dose BIBF 1120 twice daily	low dose BIBF 1120 twice daily
DRUG	intermediate dose BIBF 1120 twice daily	intermediate dose BIBF 1120 twice daily
DRUG	high dose BIBF 1120 twice daily	high dose BIBF 1120 twice daily
DRUG	placebo	placebo

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-06-01
• First posted: 2007-08-10
• Last updated: 2015-01-06
• Results posted: 2015-01-06

Locations

92 sites across 25 countries: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Netherlands, Portugal, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom