Trial · NCT05321069
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52 | The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52 | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. only patients with baseline measurement and at least one post-baseline measurement are included. | Milliliters (mL) | LEAST_SQUARES_MEAN |
| SECONDARY | Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Acute IPF Exacerbation or Death Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Hospitalization for Respiratory Cause or Death Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Absolute Decline in Forced Vital Capacity (FVC) % Predicted of >10% From Baseline or Death Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Absolute Decline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percentage Predicted by More Than 15% From Baseline or Death, Measured Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Death Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52 | The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52 | The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Fatigue Domain Score at Week 52 | The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Forced Vital Capacity Percent Predicted at Week 52 | The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 1, Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included. | FVC percent predicted | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide Percent Predicted at Week 52 | The MMRM model is a longitudinal analysis and it incorporated DLCO measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, and Week 52. The data represent the Least Squares Mean at Week 52. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included. | DLCO percent predicted | LEAST_SQUARES_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05321069/outcomes