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Completed

NCT Number: NCT00840645

A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients

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

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Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kansai, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

YM178

Drug

Oral

Other names: Mirabegron

Primary outcomes

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

    Time frame: 52 weeks

Secondary outcomes

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

    Time frame: 52 weeks

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

    Time frame: 52 weeks

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

    Time frame: 52 weeks

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

    Time frame: 52 weeks

  5. Changes from baseline in the mean number of nocturnal urinations

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Long-term Study of YM178: Long Term Study of YM178 in Subjects With Overactive Bladder

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 10, 2009
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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