NCT01366209

Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 555 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Pirfenidone	Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
DRUG	Placebo	Placebo equivalent given as 3 divided doses 3 times per day.

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2011-06-03
• Last updated: 2017-04-05
• Results posted: 2015-03-12

Locations

1 site across 1 country: United States