Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
Absolute change from baseline in FVC (mL) at Week 26
Detailed description
Absolute change from baseline in FVC (mL) at Weeks 4, 8, 12 and 18, Absolute change from baseline in FVC (% predicted) at Weeks 4, 8, 12, 18 and 26, Participants achieving relative decline from baseline in FVC (mL) ≤ 5% at Week 26, Participants with of AEs/SAEs over 26 weeks, "Participants with of clinically important findings in: - Vital signs, including blood pressure, body temperature, and pulse rate - Electrocardiogram - Laboratory: haematology, hepatobiliary, clinical chemistry "
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in FVC (mL) at Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in FVC (mL) at Weeks 4, 8, 12 and 18, Absolute change from baseline in FVC (% predicted) at Weeks 4, 8, 12, 18 and 26, Participants achieving relative decline from baseline in FVC (mL) ≤ 5% at Week 26, Participants with of AEs/SAEs over 26 weeks, "Participants with of clinically important findings in: - Vital signs, including blood pressure, body temperature, and pulse rate - Electrocardiogram - Laboratory: haematology, hepatobiliary, clinical chemistry " | — |
Countries
France, Germany, Italy, Netherlands, Poland, Spain