Trial · NCT04103450
Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
NCT04103450, Phase 3, Completed, Urovant Sciences GmbH; results first posted 2024-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia. Trials, record NCT04103450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04103450
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
- NCT number
- NCT04103450
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 276 participants, actual
- Lead sponsor
- Urovant Sciences GmbH
- Conditions
- Overactive Bladder
- Interventions
- Vibegron
- First posted
- 2019-09-25
- Last updated
- 2024-08-21
- Other registries' IDs
- eudract:2018-003136-72
- Results first posted
- 2024-08-21
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) | Up to Week 52 | Adverse events were collected in participants from time each participant provided informed consent in parent study through Follow-up Visit (approximately 5 days after the last dose of study drug) in this extension study (URO-901-3006 \[NCT03902080\]). For the 28-Week Vibegron group, AEs recorded prior to initiation of vibegron (ie, while receiving placebo in the parent study) were reported as AEs in the parent study. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAE of \>5% has been reported. |
| Primary | Number of Participants With Clinically Significant Changes in Hematology Parameters | Up to Week 52 | Blood samples were collected for the analysis of hematology parameters - Hematocrit, hemoglobin, platelet count, white blood cells (WBC \[total and differential\]), and red blood cells (RBC). |
| Primary | Number of Participants With Clinically Significant Changes in Chemistry Parameters | Up to Week 52 | Blood samples were collected for the analysis of chemistry parameters - Albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, calcium, chloride, creatininea, glucose (fasting or nonfasting), potassium, sodium, total bilirubin, direct bilirubin, blood urea nitrogen (BUN), and total cholesterol. |
| Primary | Number of Participants With Clinically Significant Changes in Urinary Parameters | Up to Week 52 | Urine samples were collected for the analysis of urinary parameters- Blood, glucose, protein, specific gravity, microscopic exam (RBCs, WBCs, epithelial cells, and bacteria), potential of hydrogen (pH) and color |
| Primary | Number of Participants With Clinically Significant Changes in Coagulation Parameter | Up to Week 52 | Blood samples were collected for the analysis of coagulation parameters- international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT). |
| Primary | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline; Week 52 | Blood pressure measurements were taken with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. Change from Baseline was calculated as maximum post-Baseline value minus Baseline value. |
| Primary | Change From Baseline in Heart Rate | Baseline; Week 52 | Heart Rate was measured with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. CFB was calculated as maximum post-Baseline value minus Baseline value. |
| Secondary | Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day | Baseline; Week 52 | Micturition is defined as "Urinated in Toilet" as indicated on Bladder Diary. Micturition episodes are the number of times participants voided in the toilet as indicated on the Bladder Diary, either by marking the 'urinated in toilet' question as yes or recording non-zero volume voided. Average number of micturition episodes/day was calculated using records within the diary analysis visit divided by non-missing diary days (diary days with at least one void reported). A "Diary Day" is defined as the time between when the participants gets up for the day (ie, the time the participant got up for the day yesterday to the time participant got up for the day today; approximately a 24-hour period). The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value. |
| Secondary | Change From Baseline at Week 52 in the Average Number of Urgency Episodes Per Day | Baseline; Week 52 | The number of urgency episodes was defined as the number of times a participant checked that they had the need to urinate immediately as indicated on the Bladder Diary. Average number of daily urgency episodes at each study visit was calculated as the total number of urgency episodes using records within the diary analysis visit windows divided by non-missing diary days. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value. |
| Secondary | Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night | Baseline; Week 52 | A nocturia episode is defined as waking to pass urine during the main sleep period as indicated on the Bladder diary. Average number of nocturia episode at each study visit was calculated as the total number of nocturia episode recorded within the diary analysis visit windows divided by non-missing diary days. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) | 52-Week Vibegron Group | Any SAE | 2 | Participants | |
| Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) | 28-Week Vibegron Group | Any SAE | 3 | Participants | |
| Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) | 52-Week Vibegron Group | Any non-SAE | 17 | Participants | |
| Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) | 28-Week Vibegron Group | Any non-SAE | 3 | Participants | |
| Number of Participants With Clinically Significant Changes in Hematology Parameters | 52-Week Vibegron Group | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in Hematology Parameters | 28-Week Vibegron Group | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in Chemistry Parameters | 52-Week Vibegron Group | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in Chemistry Parameters | 28-Week Vibegron Group | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in Urinary Parameters | 52-Week Vibegron Group | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in Urinary Parameters | 28-Week Vibegron Group | 0 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 52-Week Vibegron Group | 142 | |
| Overall Study | STARTED | 28-Week Vibegron Group | 134 | |
| Overall Study | COMPLETED | 52-Week Vibegron Group | 126 | |
| Overall Study | COMPLETED | 28-Week Vibegron Group | 124 | |
| Overall Study | NOT COMPLETED | 52-Week Vibegron Group | 16 | |
| Overall Study | NOT COMPLETED | 28-Week Vibegron Group | 10 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | 52-Week Vibegron Group | 8 | 142 | 8 |
| other | COVID-19 | Infections and infestations | 28-Week Vibegron Group | 3 | 134 | 3 |
| other | Hypertension | Investigations | 52-Week Vibegron Group | 9 | 142 | 9 |
| other | Hypertension | Investigations | 28-Week Vibegron Group | 0 | 134 | 0 |
| serious | Angina pectoris | Cardiac disorders | 52-Week Vibegron Group | 1 | 142 | 1 |
| serious | Angina pectoris | Cardiac disorders | 28-Week Vibegron Group | 0 | 134 | |
| serious | Chest pain | General disorders | 52-Week Vibegron Group | 1 | 142 | 1 |
| serious | Chest pain | General disorders | 28-Week Vibegron Group | 0 | 134 | 0 |
| serious | Atrial fibrillation | Cardiac disorders | 52-Week Vibegron Group | 0 | 142 | 0 |
| serious | Atrial fibrillation | Cardiac disorders | 28-Week Vibegron Group | 1 | 134 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 52-Week Vibegron Group | 0 | 142 |
| Total, all-cause mortality | 28-Week Vibegron Group | 0 | 134 |
| Total, other adverse events | 52-Week Vibegron Group | 17 | 142 |
| Total, other adverse events | 28-Week Vibegron Group | 3 | 134 |
| Total, serious adverse events | 52-Week Vibegron Group | 2 | 142 |
| Total, serious adverse events | 28-Week Vibegron Group | 3 | 134 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 52-Week Vibegron Group vs 28-Week Vibegron Group: Number of Participants With Clinically Significant Changes in Hematology Parameters | Trial comparisons |
| 52-Week Vibegron Group vs 28-Week Vibegron Group: Number of Participants With Clinically Significant Changes in Chemistry Parameters | Trial comparisons |
| 52-Week Vibegron Group vs 28-Week Vibegron Group: Number of Participants With Clinically Significant Changes in Coagulation Parameter | Trial comparisons |
| 52-Week Vibegron Group vs 28-Week Vibegron Group: deaths from any cause | Trial comparisons |
| 52-Week Vibegron Group vs 28-Week Vibegron Group: Number of Participants With Clinically Significant Changes in Urinary Parameters | Trial comparisons |
| 52-Week Vibegron Group vs 28-Week Vibegron Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04103450
GET https://conductscience.org/api/trials/v1/NCT04103450/results?page=2