Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (ASCEND)
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)|
- Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Active Arm||
Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
|Placebo Comparator: Placebo Arm||
Placebo equivalent given as 3 divided doses 3 times per day.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366209
|United States, California|
|Brisbane, California, United States, 94005|
|Study Chair:||For additional information, call InterMune Medical Information Telephone: 1-888-486-6411||InterMune|