Pulmonary Fibrosis Clinical Trial
Official title:
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.
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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