At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating low dose BIBF1120 once daily, low dose BIBF 1120 twice daily, and 3 other interventions for Pulmonary Fibrosis. Completed, enrolled 432 participants across 92 sites in 25 countries.
Detailed 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
Study Details
Timeline
Interventions
low dose BIBF1120 once daily
low dose BIBF 1120 twice daily
intermediate dose BIBF 1120 twice daily
high dose BIBF 1120 twice daily
placebo