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CompletedNCT00966004Updated Oct 31, 2024

A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder

A Phase 3 interventional study of YM178 and Placebo in Urinary Bladder, Overactive, sponsored by Astellas Pharma Inc. Completed at 4 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by Astellas Pharma Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,139
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.

Read the detailed description

This study examines the superiority of YM178 over the placebo and evaluates the safety and pharmacokinetics of YM178 in patients with overactive bladder, and to compare the efficacy and safety of YM178 over those of tolterodine, the control drug, without a non-inferiority test.

The drug administration period is 14 weeks in total, consisting of 2 weeks for placebo (pre-investigation period) and 12 weeks for the investigational drug (treatment period).

02

Conditions studied

  • Urinary Bladder, Overactive

Keywords

  • Urge incontinence
  • YM178
  • Overactive Bladder
  • Urgency
  • Urinary incontinence
  • mirabegron
  • Micturition
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 1,139 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient with symptoms of overactive bladder for at least 24 weeks before initiation of the pre-investigational period
  • Patient capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
  • Patient with an average frequency of micturition of 8 or more times per 24-hour period
  • Written informed consent has been obtained

Exclusion criteria

Exclusion Criteria:

  • Patients without experience of urge incontinence before informed consent
  • Patients given a clear diagnosis of stress incontinence
  • Patients with transient symptoms suspected of overactive bladder (drug induced, psychogenic, etc)
  • Patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis
  • Patients with a previous history of recurrent urinary tract infection
  • Patients complicated with or with a history of bladder tumor or prostatic tumor
  • Patients confirmed to have a post-void residual volume of ≥ 100 mL or with a clinically significant lower urinary tract obstructive disease
  • Patients given medication for the treatment of lower urinary tract obstructive disease within 4 weeks before the pre-investigational period
  • Patients with an indwelling catheter or practicing intermittent self-catheterization
  • Patients given radiotherapy influencing urethral functions, or thermotherapy for benign prostatic hyperplasia
  • Patients given surgical therapy which may influence urethral functions within 24 weeks before the pre-investigational period
  • Patients with uncontrolled hypertension or with a pulse rate ≥ 110 bpm or \< 50 bpm
  • Patients with polyuria exceeding 3000 mL in mean daily urine volume

  • Patients meeting any of the following in the examinations

    • Patients with abnormal electrocardiogram judged inappropriate as subjects by the ECG Evaluation Committee
    • Patients with AST (GOT) or ALT (GPT) 2.5 times higher than the upper limit of the normal range (or 100 IU/L)
    • Patients with a blood creatinine level ≥ 2.0 mg/dL
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,139 participants (actual)

Study arms

  • Experimental
    YM178 group

    oral

    Drug: YM178

  • Placebo comparator
    Placebo group

    oral

    Drug: Placebo

  • Active comparator
    tolterodine group

    oral

    Drug: tolterodine

Interventions

  • DrugYM178

    oral

    Also known as: mirabegron

  • DrugPlacebo

    oral

  • Drugtolterodine

    oral

    Also known as: Detrol, Detrusitol

06

What researchers measure

Primary outcomes

  1. Change from baseline in the mean number of micturitions per 24 hours

    Time frame: Within a 12-week treatment period

Secondary outcomes

  1. Change from baseline in the mean number of urgency episodes per 24 hours

    Time frame: Within a 12-week treatment period

  2. Change from baseline in the mean number of urinary incontinence episode per 24 hours

    Time frame: Within a 12-week treatment period

  3. Change from baseline in the mean number of urge incontinence episodes per 24 hours

    Time frame: Within a 12-week treatment period

  4. Change from baseline in the mean volume voided per micturition

    Time frame: Within a 12-week treatment period

  5. Change from baseline in mean number of nocturia episodes

    Time frame: Within a 12-week treatment period

  6. Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire

    Time frame: Within a 12-week treatment period

07

Study locations

4 sites
  • Chubu, Japan
  • Kantou, Japan
  • Kinki, Japan
  • Kyushu, Japan
08

References and documents

Individual participant data

Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00966004
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Aug 26, 2009
Start date
Jul 24, 2009
Primary completion
Feb 15, 2010
Completion
Feb 15, 2010
Last update
Oct 31, 2024

Study contacts

Use Central Contact
study chair · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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