Trial · NCT01638000
A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
NCT01638000, Phase 3, Completed, Astellas Pharma Europe Ltd.; results first posted 2016-08-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment. Trials, record NCT01638000. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01638000
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
- NCT number
- NCT01638000
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,887 participants, actual
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Conditions
- Urologic Diseases, Urinary Bladder, Overactive, Urinary Bladder Diseases
- Interventions
- Mirabegron, Solifenacin succinate
- First posted
- 2012-07-11
- Last updated
- 2024-11-21
- Other registries' IDs
- eudract:2011-005713-37
- Results first posted
- 2016-08-30
Source ClinicalTrials.gov
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours | Baseline and final visit (up to Week 12) | A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. |
| Secondary | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) | A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder). |
| Secondary | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | |
| Secondary | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. |
| Secondary | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. |
| Secondary | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. |
| Secondary | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. |
| Secondary | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. |
| Secondary | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency | Baseline and Week 4, Week 8, Week 12 | Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence. |
| Secondary | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 registered outcomesOutcomes47
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours | Baseline and final visit (up to Week 12) | Per Protocol Set (PPS) - all randomized participants who took ≥1 dose of double-blind study drug and who recorded ≥1 micturition in the baseline diary and ≥1 micturition in a post-baseline diary who had completed the study with no major protocol violations which could impact the primary endpoint. Last observation carried forward (LOCF) was used. | micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) | SAF population | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | Full Analysis Set (FAS) - consisted of all randomized participants who took ≥ 1 dose of double-blind study drug and who recorded ≥1 micturition measurement in the baseline diary and ≥1 micturition measurement in a post-baseline diary. N is the number of participants with available data at each time point. | micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | FAS-Incontinence (FAS-I) - consisted of all FAS participants with ≥1 incontinence episode at baseline. LOCF was used for final visit only. N is the number of participants with available data at each time point. | incontinence episodes | MEAN |
| SECONDARY | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | FAS-I population. N is the number of participants with available data at each time point. | incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | FAS-I population. LOCF was used for final visit only. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point. | urgency incontinence episodes | MEAN |
| SECONDARY | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | FAS-I population. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point. | urgency incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | FAS population. LOCF was used for final visit only. Only participants with at least one urgency episode (grade 3 or 4) at baseline were included in this analysis. N is the number of participants with available data at each time point. | urgency episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency | Baseline and Week 4, Week 8, Week 12 | FAS population. LOCF was used in final visit only. N is the number of participants with available data at each time point. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | FAS population. LOCF was used in final visit only. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point. | pads | MEAN |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 outcomesResults by group1,626
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours | Mirabegron 50 mg | -2.95 | Standard Error 0.087 | micturitions | |
| Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours | Solifenacin 5 mg | -3.13 | Standard Error 0.088 | micturitions | |
| Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Mirabegron 50 mg | Overall | 5 | percentage of participants | |
| Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Solifenacin 5 mg | Overall | 7.4 | percentage of participants | |
| Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Mirabegron 50 mg | Dry mouth | 3.1 | percentage of participants | |
| Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Solifenacin 5 mg | Dry mouth | 5.8 | percentage of participants | |
| Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Mirabegron 50 mg | Dry throat | 0.1 | percentage of participants | |
| Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Solifenacin 5 mg | Dry throat | 0.1 | percentage of participants | |
| Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Mirabegron 50 mg | Blurred vision | 0.6 | percentage of participants | |
| Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Solifenacin 5 mg | Blurred vision | 0.4 | percentage of participants |
1 to 10 of 1,626Source ClinicalTrials.gov
See all 1,626 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mirabegron 50 mg | 943 | |
| Overall Study | STARTED | Solifenacin 5 mg | 944 | |
| Overall Study | Received at Least 1 Double-Blind Dose | Mirabegron 50 mg | 936 | |
| Overall Study | Received at Least 1 Double-Blind Dose | Solifenacin 5 mg | 934 | |
| Overall Study | COMPLETED | Mirabegron 50 mg | 883 | |
| Overall Study | COMPLETED | Solifenacin 5 mg | 873 | |
| Overall Study | NOT COMPLETED | Mirabegron 50 mg | 60 | |
| Overall Study | NOT COMPLETED | Solifenacin 5 mg | 71 |
Source ClinicalTrials.gov
Adverse events66
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 | Mirabegron 50 mg | 29 | 936 | |
| other | Dry mouth | Gastrointestinal disorders | Solifenacin 5 mg | 54 | 934 | |
| serious | Pneumonia | Infections and infestations | Mirabegron 50 mg | 1 | 936 | |
| serious | Pneumonia | Infections and infestations | Solifenacin 5 mg | 2 | 934 | |
| serious | Appendicitis | Infections and infestations | Mirabegron 50 mg | 0 | 936 | |
| serious | Appendicitis | Infections and infestations | Solifenacin 5 mg | 1 | 934 | |
| serious | Pyelonephritis | Infections and infestations | Mirabegron 50 mg | 1 | 936 | |
| serious | Pyelonephritis | Infections and infestations | Solifenacin 5 mg | 0 | 934 | |
| serious | Pyelonephritis acute | Infections and infestations | Mirabegron 50 mg | 1 | 936 | |
| serious | Pyelonephritis acute | Infections and infestations | Solifenacin 5 mg | 0 | 934 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirabegron 50 mg | ||
| Total, all-cause mortality | Solifenacin 5 mg | ||
| Total, other adverse events | Mirabegron 50 mg | 29 | 936 |
| Total, other adverse events | Solifenacin 5 mg | 54 | 934 |
| Total, serious adverse events | Mirabegron 50 mg | 14 | 936 |
| Total, serious adverse events | Solifenacin 5 mg | 13 | 934 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Mirabegron 50 mg vs Solifenacin 5 mg: serious adverse events |
Source 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/NCT01638000
GET https://conductscience.org/api/trials/v1/NCT01638000/registered?page=2