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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: Completed Phase 3 study, sponsored by Genentech.
NCT01366209 is a Phase 3 study that has completed, run by Genentech. The registered enrollment target is 555 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 555 participants |
| Start Date | 2011-06 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT01366209 record still lists
NCT01366209 is an interventional study that assigns participants to a tested intervention. The registered 555 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01366209 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01366209's enrollment target sits among peer trials
555 676th of 2000 higher than 1,323 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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