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

Part of paid clinical trials in Brisbane, California.

Sponsor
Genentech, Inc.
Study ID
NCT01366209
Phase
PHASE3
Status
Completed

Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2011
Status verified
Mar 2017
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

Enrollment
555 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Arm
  • Placebo Comparator: Placebo Arm

Primary Outcome Measure

Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 [ Time Frame: 52 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
InterMune Inc.BrisbaneCalifornia94005-

Find similar trials in Brisbane, CA

By research site
InterMune Inc.· Brisbane, CA

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