CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 435 enrolled
Drug / intervention
Pirfenidone +1 moredrug
Likely dose
Pirfenidone 2403 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00287716
NCT00287716Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

Genentech, Inc.·interventional·Posted Feb 7, 2006·Updated May 22, 2017

In Brief

A Phase 3 clinical trial evaluating Pirfenidone and Placebo for Idiopathic Pulmonary Fibrosis. Completed, enrolled 435 participants across 1 site.

Detailed Summary

The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2006
Enrollment StartJul 14, 2006
Primary CompletionNov 10, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.4 years ago

Interventions

Pirfenidonedrug

1197 or 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study.

Placebodrug

Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.