Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Pirfenidone ASCEND IPF FVC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 555
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Pirfenidone intervention 2: Placebo
Intervention descriptions: intervention 1: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day. intervention 2: Placebo equivalent given as 3 divided doses 3 times per day.

Protocol document: