TriangleNCT00410514 · OUTCOME
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Incontinence episodes
- Interval / dispersion
- Standard Error
- Time frame
- Baseline and Weeks 1, 4, 8 and 12
What was measured
The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
Analysis population: Full Analysis Set included all patients who received at least 1 dose of double-blind study drug \& had both Qmax \& PdetQmax measurements at Baseline \& 1 or both at any postbaseline on-treatment visit. The analysis only includes patients with \>0 incontinence episodes at baseline. End of treatment (EOT) includes patients who didn't complete Week 12.
Groups in this outcome
Placebo
Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
Mirabegron 50 mg
Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
Mirabegron 100 mg
Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
| Group | Source count |
|---|---|
| Placebo | 63 |
| Mirabegron 50 mg | 64 |
| Mirabegron 100 mg | 58 |
Reported measurements
Change from Baseline at Week 1 [N=9; 18; 13]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -1.16 | 0.561 | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | -0.18 | 0.386 | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | -0.97 | 0.516 | Not reported | Not reported | Not reported |
Change from Baseline at Week 4 [N=9; 18; 13
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -0.99 | 0.638 | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | -0.42 | 0.439 | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | -1.60 | 0.586 | Not reported | Not reported | Not reported |
Change from Baseline at Week 8 [N=9; 17; 13]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -0.77 | 0.558 | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | -0.70 | 0.396 | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | -2.31 | 0.513 | Not reported | Not reported | Not reported |
Change from Baseline at Week 12 [N=9; 17; 13]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -0.98 | 0.528 | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | -0.91 | 0.374 | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | -2.03 | 0.485 | Not reported | Not reported | Not reported |
Change from Baseline at EOT [N=9; 18; 13]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -0.96 | 0.516 | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | -0.89 | 0.355 | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | -1.98 | 0.474 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.561
- value
- -1.16
- group Id
- OG001
- spread
- 0.386
- value
- -0.18
- group Id
- OG002
- spread
- 0.516
- value
- -0.97
- title
- Change from Baseline at Week 1 [N=9; 18; 13]
- categories
- measurements
- group Id
- OG000
- spread
- 0.638
- value
- -0.99
- group Id
- OG001
- spread
- 0.439
- value
- -0.42
- group Id
- OG002
- spread
- 0.586
- value
- -1.60
- title
- Change from Baseline at Week 4 [N=9; 18; 13
- categories
- measurements
- group Id
- OG000
- spread
- 0.558
- value
- -0.77
- group Id
- OG001
- spread
- 0.396
- value
- -0.70
- group Id
- OG002
- spread
- 0.513
- value
- -2.31
- title
- Change from Baseline at Week 8 [N=9; 17; 13]
- categories
- measurements
- group Id
- OG000
- spread
- 0.528
- value
- -0.98
- group Id
- OG001
- spread
- 0.374
- value
- -0.91
- group Id
- OG002
- spread
- 0.485
- value
- -2.03
- title
- Change from Baseline at Week 12 [N=9; 17; 13]
- categories
- measurements
- group Id
- OG000
- spread
- 0.516
- value
- -0.96
- group Id
- OG001
- spread
- 0.355
- value
- -0.89
- group Id
- OG002
- spread
- 0.474
- value
- -1.98
- title
- Change from Baseline at EOT [N=9; 18; 13]
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 58
- units
- Participants
- description
- The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
- dispersion Type
- Standard Error
- groups
- description
- Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
- id
- OG000
- title
- Placebo
- description
- Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
- id
- OG001
- title
- Mirabegron 50 mg
- description
- Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
- id
- OG002
- title
- Mirabegron 100 mg
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Full Analysis Set included all patients who received at least 1 dose of double-blind study drug \& had both Qmax \& PdetQmax measurements at Baseline \& 1 or both at any postbaseline on-treatment visit. The analysis only includes patients with \>0 incontinence episodes at baseline. End of treatment (EOT) includes patients who didn't complete Week 12.
- reporting Status
- POSTED
- time Frame
- Baseline and Weeks 1, 4, 8 and 12
- title
- Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
- type
- SECONDARY
- unit Of Measure
- Incontinence episodes
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice