NCT00840645

Brief Summary

The study is intended to test the safety, tolerability, and efficacy of long-term treatment with YM178 in patients with overactive bladder symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

February 8, 2009

Last Update Submit

January 4, 2016

Conditions

Urinary Bladder, Overactive

Keywords

YM178Urinary Bladder, OveractiveMirabegron

Outcome Measures

Primary Outcomes (1)

  • Vital signs, AEs, lab tests, ECG, post-void residual volume

    52 weeks

Secondary Outcomes (5)

  • Changes from baseline in the mean number of micturitions/24hrs

    52 weeks

  • Changes from baseline in the mean number of urinary urgencies/24 hrs

    52 weeks

  • Changes from baseline in the mean number of incontinence episodes/24 hrs

    52 weeks

  • Changes from baseline in the mean number of urge incontinence episodes/24 hrs

    52 weeks

  • Changes from baseline in the mean number of nocturnal urinations

    52 weeks

Study Arms (1)

1. YM178

EXPERIMENTAL
Drug: YM178

Interventions

YM178DRUG

Oral

Also known as: Mirabegron
1. YM178

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has symptoms of overactive bladder for \>= 24 wks
  • Subject experiences frequency of micturition at average \>= 8 times per 24 hrs confirmed by the 3-day patient diary

You may not qualify if:

  • Subject is breastfeeding, pregnant, or intends to become pregnant during the study
  • Subject obviously has stress incontinence
  • Subject has an indwelling catheter or practices intermittent self catheterization
  • Subject has evidence of symptomatic urinary tract infection, interstitial cystitis, bladder stone, etc
  • Subject has an average total daily urine volume \> 3000 mL confirmed by patient diary
  • Subject has uncontrollable hypertension (SBP \>= 180 mmHg or DBP \>= 110 mmHg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Related Links

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2009

First Posted

February 10, 2009

Study Start

December 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

JP(2)