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NCT00410514 · OUTCOME

Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours

A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO) · Source last updated 2014-04-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
LEAST_SQUARES_MEAN
Unit
micturitions
Interval / dispersion
Standard Error
Time frame
Baseline and Weeks 1, 4, 8 and 12

What was measured

A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions 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: The 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. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo63
Mirabegron 50 mg64
Mirabegron 100 mg58

Reported measurements

Change from Baseline at Week 1 [N=63; 64; 57]
Values in micturitions · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-0.150.295Not reportedNot reportedNot reported
Mirabegron 50 mg-0.580.291Not reportedNot reportedNot reported
Mirabegron 100 mg-0.480.311Not reportedNot reportedNot reported
Change from Baseline at Week 4 [N=63; 64; 58]
Values in micturitions · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-0.360.333Not reportedNot reportedNot reported
Mirabegron 50 mg-0.900.328Not reportedNot reportedNot reported
Mirabegron 100 mg-1.360.347Not reportedNot reportedNot reported
Change from Baseline at Week 8 [N=62; 63; 57]
Values in micturitions · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-0.610.337Not reportedNot reportedNot reported
Mirabegron 50 mg-1.320.333Not reportedNot reportedNot reported
Mirabegron 100 mg-1.410.352Not reportedNot reportedNot reported
Change from Baseline at Week 12 [N=62; 63; 54]
Values in micturitions · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-0.270.322Not reportedNot reportedNot reported
Mirabegron 50 mg-1.330.318Not reportedNot reportedNot reported
Mirabegron 100 mg-1.230.348Not reportedNot reportedNot reported
Change from Baseline at EOT [N=63; 64; 58]
Values in micturitions · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-0.310.317Not reportedNot reportedNot reported
Mirabegron 50 mg-1.350.313Not reportedNot reportedNot reported
Mirabegron 100 mg-1.370.331Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.295
        value
        -0.15
      2. group Id
        OG001
        spread
        0.291
        value
        -0.58
      3. group Id
        OG002
        spread
        0.311
        value
        -0.48
    title
    Change from Baseline at Week 1 [N=63; 64; 57]
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.333
        value
        -0.36
      2. group Id
        OG001
        spread
        0.328
        value
        -0.90
      3. group Id
        OG002
        spread
        0.347
        value
        -1.36
    title
    Change from Baseline at Week 4 [N=63; 64; 58]
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.337
        value
        -0.61
      2. group Id
        OG001
        spread
        0.333
        value
        -1.32
      3. group Id
        OG002
        spread
        0.352
        value
        -1.41
    title
    Change from Baseline at Week 8 [N=62; 63; 57]
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.322
        value
        -0.27
      2. group Id
        OG001
        spread
        0.318
        value
        -1.33
      3. group Id
        OG002
        spread
        0.348
        value
        -1.23
    title
    Change from Baseline at Week 12 [N=62; 63; 54]
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.317
        value
        -0.31
      2. group Id
        OG001
        spread
        0.313
        value
        -1.35
      3. group Id
        OG002
        spread
        0.331
        value
        -1.37
    title
    Change from Baseline at EOT [N=63; 64; 58]
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      64
    3. group Id
      OG002
      value
      58
    units
    Participants
description
A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions 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
  1. description
    Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
    id
    OG000
    title
    Placebo
  2. description
    Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
    id
    OG001
    title
    Mirabegron 50 mg
  3. 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
The 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. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.
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 Micturitions Per 24 Hours
type
SECONDARY
unit Of Measure
micturitions

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Preserved source evidence · Not medical advice