A Study of YM178 in Subjects With Symptoms of Overactive Bladder

Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder

This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Overactive
• Intervention / Treatment: Drug: Placebo; Drug: YM178; Drug: tolterodine ER

• Study Type: Interventional
• Enrollment (Actual): 1126
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Dalian, China
  • Fuzhou, China
  • Guangzhou, China
  • Hangzhou, China
  • Hubei, China
  • Hunan, China
  • Jiangsu, China
  • Liaoning, China
  • Nanjing, China
  • Shanghai, China
• India
  • Ahmedabad, India
  • Gurgaon, India
  • Jaipur, India
  • Lucknow, India
  • New Delhi, India
  • Pune, India
• Korea, Republic of
  • Busan, Korea, Republic of
  • Chungcheong Namdo, Korea, Republic of
  • Daegu, Korea, Republic of
  • Daejeon, Korea, Republic of
  • Gwangju, Korea, Republic of
  • Gyeonggi, Korea, Republic of
  • Incheon, Korea, Republic of
  • Jeollabuk, Korea, Republic of
  • Jeollanam, Korea, Republic of
  • Kyonggi, Korea, Republic of
  • Seoul, Korea, Republic of
• Taiwan
  • Chia-Yi, Taiwan
  • Hualien, Taiwan
  • Kaohsiung, Taiwan
  • Taichung, Taiwan
  • Tainan, Taiwan
  • Taipei, Taiwan
  • Taoyuan, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects with symptoms of overactive bladder for at least 12 weeks before the study
• Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
• Subject with an average frequency of micturition of 8 or more times per 24-hour period
• Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period
• Subject having provided written informed consent by him/herself

Exclusion Criteria:

• Subject having stress urinary incontinence as a predominant symptom
• Subject with transient symptoms suspected for overactive bladder
• Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection
• Subject complicated with bladder tumor/prostatic tumor or with the historical condition
• Subject confirmed to have a post-void residual volume of >=100ml or with a clinically significant lower urinary tract obstructive disease
• Subject with indwelling catheter or practicing intermittent self-catheterization
• Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia
• Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study
• Subject with uncontrolled hypertension (indicated by sitting SBP >=180mmHg or DPB >= 110mmHg)
• Subject with a pulse rate >= 110bpm or <50 bpm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YM178 group; oral	Drug: YM178; oral; Other Names: mirabegron
Placebo Comparator: placebo group; oral	Drug: Placebo; oral
Experimental: tolterodine ER group; oral	Drug: tolterodine ER; oral; Other Names: Detrusitol SR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in mean number of micturitions per 24 hrs	Within a 12-week treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in mean number of urgency episodes per 24 hrs	Within a 12-week treatment period
Change in mean number of urinary incontinence episodes per 24 hrs	Within a 12-week treatment period
Change in mean number of urge incontinence episodes per 24 hrs	Within a 12-week treatment period
Change in mean volume voided per micturition	Within a 12-week treatment period
Change in mean number of nocturia episodes	Within a 12-week treatment period
Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume	During 12-week treatment

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Chair: Use Central Contact, Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2009
• Primary Completion (Actual): September 16, 2011
• Study Completion (Actual): September 16, 2011

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: January 6, 2010
• First Posted (Estimated): January 7, 2010

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Urinary incontinence; Overactive Bladder; YM178; Urgency; Frequency; Micturition; Urinary urge incontinence
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Bladder, Overactive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Adrenergic Agonists; Adrenergic Agents; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Urological Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Tolterodine Tartrate; Mirabegron
• Other Study ID Numbers: 178-CL-090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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/.
• IPD Sharing Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• IPD Sharing Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR