Trial · NCT04103450
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) | Up to Week 52 | SAF-Ext Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Hematology Parameters | Up to Week 52 | SAF-Ext Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Chemistry Parameters | Up to Week 52 | SAF-Ext Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Urinary Parameters | Up to Week 52 | SAF Ext Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Coagulation Parameter | Up to Week 52 | SAF Ext Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline; Week 52 | SAF-Ext Population. | Millimeters of mercury | MEAN |
| PRIMARY | Change From Baseline in Heart Rate | Baseline; Week 52 | SAF Ext Population. | Beats per minute | MEAN |
| SECONDARY | Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day | Baseline; Week 52 | Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment. | Micturition Episodes per Day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 52 in the Average Number of Urgency Episodes Per Day | Baseline; Week 52 | Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment. | Urgency Episodes per Day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night | Baseline; Week 52 | Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment. | Nocturia Episodes per Night | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day in Participants With Incontinence | Baseline; Week 52 | Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment. | UUI Episodes per day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall) | Baseline; Week 52 | Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 52 in the Average Volume Voided Per Micturition | Baseline; Week 52 | Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment. | Milliliters | 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/NCT04103450/outcomes