Trial · NCT03583372
An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
NCT03583372, Phase 3, Completed, Urovant Sciences GmbH; results first posted 2021-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB). Trials, record NCT03583372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03583372
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
- NCT number
- NCT03583372
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 506 participants, actual
- Lead sponsor
- Urovant Sciences GmbH
- Conditions
- Overactive Bladder
- Interventions
- Vibegron, placebos, Tolterodine Tartrate ER
- First posted
- 2018-07-11
- Last updated
- 2021-03-18
- Other registries' IDs
- eudract:2017-003294-33
- Results first posted
- 2021-02-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With the Indicated Type of Treatment-emergent Adverse Event | up to 56 weeks | Adverse events were collected in participants with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first. |
| Secondary | Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants | Baseline; Week 52 | A micturition/void is defined as "Urinated in Toilet" as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a participant voided in the toilet as indicated in the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures (MMRM) were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex. |
| Secondary | CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants | Baseline; Week 52 | The number of UUI episodes is defined as the number of times a participant had checked "urge" as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to "urge" was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. Only participants with evaluable data were analyzed. |
| Secondary | CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants | Baseline; Week 52 | The number of urgency episodes is defined as the number of times a participant had checked "need to urinate immediately" on a CDD divided by the number of CDDs in the PVD. CFB is calculated as the post-BL value minus the BL value. "Over 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex. |
| Secondary | CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants | Baseline; Week 52 | The number of total incontinence episodes is defined as the number of times a participant had checked the accidental urine leakage box in the PVD, including for reasons of "urge," "stress," or "other." CFB was calculated as the post-BL value minus the BL value. "Over 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. hr = hour. |
Source ClinicalTrials.gov
Outcomes5
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 the Indicated Type of Treatment-emergent Adverse Event | up to 56 weeks | Safety Extension Set (SAF-Ext) Population: all participants who received at least 1 dose of double-blind study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Adverse event datasets for Study RVT-901-3003 and Study RVT-901-3004 were combined for the safety analyses. | participants | NUMBER |
| SECONDARY | Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants | Baseline; Week 52 | Full Analysis Set Extension (FAS-Ext) Population: all randomized OAB participants who took at least 1 dose of double-blind study treatment during this extension study and had at least 1 subsequent evaluable CFB micturition measurement in this extension study. Only participants with evaluable data were analyzed. | micturitions per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants | Baseline; Week 52 | Full Analysis Set Extension for Incontinence (FAS-Ext-I) Population: all randomized OAB Wet participants who were included in the FAS-I population in Study RVT-901-3003, who took at least 1 dose of double-blind study treatment in this extension study and had at least 1 subsequent evaluable CFB UUI measurement. | UUI episodes per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants | Baseline; Week 52 | FAS-Ext Population. Only participants with evaluable data were analyzed. | urgency episodes over 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants | Baseline; Week 52 | FAS-Ext-I Population. Only participants with evaluable data were analyzed. | Urinary incontinence episodes over 24 hr | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group26
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 the Indicated Type of Treatment-emergent Adverse Event | Overall Vibegron 75 mg | Any TEAE | 171 | participants | |
| Number of Participants With the Indicated Type of Treatment-emergent Adverse Event | Overall Tolterodine ER 4 mg | Any TEAE | 126 | participants | |
| Number of Participants With the Indicated Type of Treatment-emergent Adverse Event | Overall Vibegron 75 mg | Any study drug-related TEAE | 59 | participants | |
| Number of Participants With the Indicated Type of Treatment-emergent Adverse Event | Overall Tolterodine ER 4 mg | Any study drug-related TEAE | 46 | participants | |
| Number of Participants With the Indicated Type of Treatment-emergent Adverse Event | Overall Vibegron 75 mg | Any Grade ≥ 3 TEAE | 10 | participants | |
| Number of Participants With the Indicated Type of Treatment-emergent Adverse Event | Overall Tolterodine ER 4 mg | Any Grade ≥ 3 TEAE | 8 | participants | |
| Number of Participants With the Indicated Type of Treatment-emergent Adverse Event | Overall Vibegron 75 mg | Any Grade ≥ 3 study drug-related TEAE | 1 | participants | |
| Number of Participants With the Indicated Type of Treatment-emergent Adverse Event | Overall Tolterodine ER 4 mg | Any Grade ≥ 3 study drug-related TEAE | 1 | participants | |
| Number of Participants With the Indicated Type of Treatment-emergent Adverse Event | Overall Vibegron 75 mg | Any treatment-emergent (TE) SAE | 9 | participants | |
| Number of Participants With the Indicated Type of Treatment-emergent Adverse Event | Overall Tolterodine ER 4 mg | Any treatment-emergent (TE) SAE | 10 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 40 Weeks Vibegron 75 mg | 92 | |
| Overall Study | STARTED | 52 Weeks Vibegron 75 mg | 182 | |
| Overall Study | STARTED | 40 Weeks Tolterodine ER 4 mg | 91 | |
| Overall Study | STARTED | 52 Weeks Tolterodine ER 4 mg | 141 | |
| Overall Study | COMPLETED | 40 Weeks Vibegron 75 mg | 79 | |
| Overall Study | COMPLETED | 52 Weeks Vibegron 75 mg | 156 | |
| Overall Study | COMPLETED | 40 Weeks Tolterodine ER 4 mg | 72 | |
| Overall Study | COMPLETED | 52 Weeks Tolterodine ER 4 mg | 123 | |
| Overall Study | NOT COMPLETED | 40 Weeks Vibegron 75 mg | 13 | |
| Overall Study | NOT COMPLETED | 52 Weeks Vibegron 75 mg | 26 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events48
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 | Dry mouth | Gastrointestinal disorders | Overall Vibegron 75 mg | 5 | 273 | |
| other | Dry mouth | Gastrointestinal disorders | Overall Tolterodine ER 4 mg | 12 | 232 | |
| other | Nasopharyngitis | Infections and infestations | Overall Vibegron 75 mg | 13 | 273 | |
| other | Nasopharyngitis | Infections and infestations | Overall Tolterodine ER 4 mg | 12 | 232 | |
| other | Urinary tract infection | Infections and infestations | Overall Vibegron 75 mg | 18 | 273 | |
| other | Urinary tract infection | Infections and infestations | Overall Tolterodine ER 4 mg | 17 | 232 | |
| other | Headache | Nervous system disorders | Overall Vibegron 75 mg | 15 | 273 | |
| other | Headache | Nervous system disorders | Overall Tolterodine ER 4 mg | 9 | 232 | |
| other | Hypertension | Vascular disorders | Overall Vibegron 75 mg | 24 | 273 | |
| other | Hypertension | Vascular disorders | Overall Tolterodine ER 4 mg | 20 | 232 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Overall Vibegron 75 mg | 1 | 273 |
| Total, all-cause mortality | Overall Tolterodine ER 4 mg | 0 | 232 |
| Total, other adverse events | Overall Vibegron 75 mg | 65 | 273 |
| Total, other adverse events | Overall Tolterodine ER 4 mg | 56 | 232 |
| Total, serious adverse events | Overall Vibegron 75 mg | 9 | 273 |
| Total, serious adverse events | Overall Tolterodine ER 4 mg | 10 | 232 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33356445 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Overall Vibegron 75 mg vs Overall Tolterodine ER 4 mg: deaths from any cause | Trial comparisons |
| Overall Vibegron 75 mg vs Overall Tolterodine ER 4 mg: 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/NCT03583372
GET https://conductscience.org/api/trials/v1/NCT03583372/results?page=2