PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
555
Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
Placebo equivalent given as 3 divided doses 3 times per day.
InterMune Inc.
Brisbane, California, United States
Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52
Time frame: 52 weeks
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