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NCT00410514 · OUTCOME

Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition

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
mL
Interval / dispersion
Standard Error
Time frame
Baseline and Weeks 1, 4, 8 and 12

What was measured

The mean volume voided per micturition 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 mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo2.754.580Not reportedNot reportedNot reported
Mirabegron 50 mg6.714.508Not reportedNot reportedNot reported
Mirabegron 100 mg10.384.833Not reportedNot reportedNot reported
Change from Baseline at Week 4 [N=63; 64; 58]
Values in mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo10.254.779Not reportedNot reportedNot reported
Mirabegron 50 mg12.554.705Not reportedNot reportedNot reported
Mirabegron 100 mg18.315.001Not reportedNot reportedNot reported
Change from Baseline at Week 8 [N=62; 63; 57]
Values in mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo4.534.930Not reportedNot reportedNot reported
Mirabegron 50 mg14.524.859Not reportedNot reportedNot reported
Mirabegron 100 mg22.835.163Not reportedNot reportedNot reported
Change from Baseline at Week 12 [N=62; 63; 54]
Values in mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo4.494.610Not reportedNot reportedNot reported
Mirabegron 50 mg16.624.549Not reportedNot reportedNot reported
Mirabegron 100 mg16.205.000Not reportedNot reportedNot reported
Change from Baseline at EOT [N=63; 64; 58]
Values in mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo5.404.608Not reportedNot reportedNot reported
Mirabegron 50 mg15.824.537Not reportedNot reportedNot reported
Mirabegron 100 mg15.804.823Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.580
        value
        2.75
      2. group Id
        OG001
        spread
        4.508
        value
        6.71
      3. group Id
        OG002
        spread
        4.833
        value
        10.38
    title
    Change from Baseline at Week 1 [N=63; 64; 57]
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.779
        value
        10.25
      2. group Id
        OG001
        spread
        4.705
        value
        12.55
      3. group Id
        OG002
        spread
        5.001
        value
        18.31
    title
    Change from Baseline at Week 4 [N=63; 64; 58]
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.930
        value
        4.53
      2. group Id
        OG001
        spread
        4.859
        value
        14.52
      3. group Id
        OG002
        spread
        5.163
        value
        22.83
    title
    Change from Baseline at Week 8 [N=62; 63; 57]
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.610
        value
        4.49
      2. group Id
        OG001
        spread
        4.549
        value
        16.62
      3. group Id
        OG002
        spread
        5.000
        value
        16.20
    title
    Change from Baseline at Week 12 [N=62; 63; 54]
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.608
        value
        5.40
      2. group Id
        OG001
        spread
        4.537
        value
        15.82
      3. group Id
        OG002
        spread
        4.823
        value
        15.80
    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
The mean volume voided per micturition 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 Voided Volume Per Micturition
type
SECONDARY
unit Of Measure
mL

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Preserved source evidence · Not medical advice