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NCT00287716 · ClinicalTrials.gov registry record · Phase 3
Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
A Phase 3 study of Idiopathic Pulmonary Fibrosis, sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 435
- Enrollment target
- 1
- Study location
NCT00287716 is a Phase 3 study of Idiopathic Pulmonary Fibrosis that has completed, run by Genentech. The registered enrollment target is 435 participants, below the 743-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00287716, a Phase 3 study of Idiopathic Pulmonary Fibrosis, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 435 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pirfenidone
Study Locations (1)
California
- InterMune, Inc. - Brisbane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 435 participants |
| Start Date | 2006-07-14 |
| Est. Completion | 2008-11-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00287716
The ClinicalTrials.gov registry entry for NCT00287716 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 435 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 743-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (41% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00287716 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00287716 about?
NCT00287716 is a clinical study titled "Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis". 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 idiop...
What is the current status of trial NCT00287716?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 435 participants. The study started on 2006-07-14. Estimated completion is 2008-11-10.
What conditions does trial NCT00287716 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis.
What interventions are being tested in trial NCT00287716?
The interventions under investigation include: Placebo (DRUG), Pirfenidone (DRUG).
Who is sponsoring clinical trial NCT00287716?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00287716 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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