Conditions: Pulmonary Fibrosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 432
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: low dose BIBF1120 once daily arm 2: low dose BIBF 1120 twice daily arm 3: intermediate dose BIBF 1120 twice daily arm 4: high dose BIBF 1120 twice daily arm 5: placebo

Interventions: intervention 1: low dose BIBF1120 once daily intervention 2: low dose BIBF 1120 twice daily intervention 3: intermediate dose BIBF 1120 twice daily intervention 4: high dose BIBF 1120 twice daily intervention 5: placebo
Intervention descriptions: intervention 1: low dose BIBF1120 once daily intervention 2: low dose BIBF 1120 twice daily intervention 3: intermediate dose BIBF 1120 twice daily intervention 4: high dose BIBF 1120 twice daily intervention 5: placebo

Protocol document: