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NCT01366209 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Genentech.

Completed
Registry status
Phase 3
Development phase
555
Enrollment target

NCT01366209 is a Phase 3 study that has completed, run by Genentech. The registered enrollment target is 555 participants.

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The verdict

NCT01366209, a Phase 3 study, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 3
Development phase
555 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Pirfenidone

Trial Details

FieldValue
Enrollment Target 555 participants
Start Date 2011-06
Est. Completion 2014-02
Phase Phase 3

Sponsor

Genentech

332 total trials

What the Registry Record Tells You About NCT01366209

The ClinicalTrials.gov registry entry for NCT01366209 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 555 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01366209 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01366209 about?

NCT01366209 is a clinical study titled "Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)". 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 fo...

What is the current status of trial NCT01366209?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 555 participants. The study started on 2011-06. Estimated completion is 2014-02.

What interventions are being tested in trial NCT01366209?

The interventions under investigation include: Placebo (DRUG), Pirfenidone (DRUG).

Who is sponsoring clinical trial NCT01366209?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.