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NCT00410514 · OUTCOME

Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)

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/sec
Interval / dispersion
Standard Error
Time frame
Baseline and Week 12

What was measured

Maximum urinary flow rate (Qmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation. Least squares means (LSM) were derived from an analysis of covariance (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. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.

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

Source class 1
Values in mL/sec · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-0.330.370Not reportedNot reportedNot reported
Mirabegron 50 mg0.070.366Not reportedNot reportedNot reported
Mirabegron 100 mg0.300.388Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.42
    estimate Comment
    Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.
    group Description
    The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    LS Mean Difference
    param Value
    0.40
    statistical Method
    ANCOVA
    tested Non Inferiority
    true
  2. ci Lower Limit
    -0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.68
    estimate Comment
    Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.
    group Description
    The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    LS Mean Difference
    param Value
    0.62
    statistical Method
    ANCOVA
    tested Non Inferiority
    true
Complete source fields
analyses
  1. ci Lower Limit
    -0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.42
    estimate Comment
    Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.
    group Description
    The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    LS Mean Difference
    param Value
    0.40
    statistical Method
    ANCOVA
    tested Non Inferiority
    true
  2. ci Lower Limit
    -0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.68
    estimate Comment
    Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.
    group Description
    The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    LS Mean Difference
    param Value
    0.62
    statistical Method
    ANCOVA
    tested Non Inferiority
    true
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.370
        value
        -0.33
      2. group Id
        OG001
        spread
        0.366
        value
        0.07
      3. group Id
        OG002
        spread
        0.388
        value
        0.30
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      64
    3. group Id
      OG002
      value
      58
    units
    Participants
description
Maximum urinary flow rate (Qmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation. Least squares means (LSM) were derived from an analysis of covariance (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. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.
reporting Status
POSTED
time Frame
Baseline and Week 12
title
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
type
PRIMARY
unit Of Measure
mL/sec

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