CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 555 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/NCT01366209
NCT01366209Phase 3Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted Jun 3, 2011·Updated Apr 5, 2017

In Brief

A Phase 3 clinical trial evaluating Pirfenidone and Placebo for Idiopathic Pulmonary Fibrosis. Completed, enrolled 555 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2011
Enrollment StartJun 1, 2011
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.1 years ago

Interventions

Pirfenidonedrug

Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.

Placebodrug

Placebo equivalent given as 3 divided doses 3 times per day.