Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Pirfenidone in Idiopathic Pulmonary Fibrosis (CAPACITY 006)
NCT00287729Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2006
- Primary completion
- Nov 2008
- Countries
- 1
- Sponsor
- Genentech
- Modality
- Small Molecules
- Drugs
- pirfenidone
- Conditions
- idiopathic pulmonary fibrosis (IPF)
01
Overview
Phase 3, randomised, double-blind trial in idiopathic pulmonary fibrosis (IPF) comparing 2403 mg/day pirfenidone with Placebo (2 arms). Primary endpoint: Absolute Change in Percent Predicted Forced Vital Capacity at Week 72. Started Apr 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
2403 mg/day pirfenidone
Pirfenidone 2403 mg/day administered in divided doses TID with food.
Placebo
Placebo equivalent administered in divided doses TID with food.
03
Endpoints
Primary
Absolute Change in Percent Predicted Forced Vital Capacity
Secondary
Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity
Progression-free Survival
Change in the Six-Minute Walk Test Distance
Change in Worst Oxygen Saturation by Pulse Oximetry Observed During the 6-Minute Walk Test
Change in Percent Predicted Hemoglobin-Corrected Carbon Monoxide Diffusing Capacity of the Lungs
Change in Dyspnea Score
Worsening of Idiopathic Pulmonary Fibrosis
Beyond the preview
Go deeper on NCT00287729.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00287729.