At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomised, Placebo-controlled (Within a Dose Group) Study to Evaluate Safety and Pharmacokinetics of Multiple Rising Doses of BIBF 1120 at 50 mg Bid (14 Days), 100 mg Bid (14 Days), and 150 mg Bid (28 Days) p.o., on Top of Standard Medical Care With Stratification According to Pirfenidone Use, in Japanese Patients With Idiopathic Pulmonary Fibrosis.
In Brief
A Phase 2 clinical trial evaluating Placebo and BIBF 1120 for Idiopathic Pulmonary Fibrosis. Completed, enrolled 50 participants across 8 sites.
Detailed Summary
To investigate safety of BIBF 1120 in Japanese patients with idiopathic pulmonary fibrosis (IPF), with and without pirfenidone background treatment. To assess pharmacokinetics of BIBF 1120 in Japanese patients, with and without pirfenidone background treatment. To assess pharmacokinetics of pirfenidone in Japanese patients, alone and in combination with BIBF 1120 treatment.
Study Details
Timeline
Interventions
Placebo BID for cohort 1,2,3
50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively
50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively
50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively