NCT00527033

Brief Summary

Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability compared to placebo

Trial Health

87
On Track

Trial Health Score

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

Enrollment
842

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

5 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

First Submitted

Initial submission to the registry

September 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

September 11, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2008

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

September 6, 2007

Last Update Submit

October 29, 2024

Conditions

Urinary Bladder, Overactive

Keywords

YM178Urinary Bladder, Overactive

Outcome Measures

Primary Outcomes (1)

  • Overactive bladder symptoms

    12 weeks

Secondary Outcomes (1)

  • Overactive bladder symptoms (QOL)

    12 weeks

Study Arms (4)

1

EXPERIMENTAL

Oral

Drug: YM178

2

EXPERIMENTAL

Oral

Drug: YM178

3

EXPERIMENTAL

Oral

Drug: YM178

4

PLACEBO COMPARATOR

Oral

Drug: Placebo

Interventions

YM178DRUG

Oral

123
PlaceboDRUG

Oral

4

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 20 years suffering from overactive bladder

You may not qualify if:

  • Pregnant and breastfeeding women
  • Any clinically significant abnormal conditions which in the opinion of the investigator makes the patient unsuitable for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Related Publications (1)

  • Yamaguchi O, Marui E, Igawa Y, Takeda M, Nishizawa O, Ikeda Y, Ohkawa S. Efficacy and Safety of the Selective beta3 -Adrenoceptor Agonist Mirabegron in Japanese Patients with Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study. Low Urin Tract Symptoms. 2015 May;7(2):84-92. doi: 10.1111/luts.12053. Epub 2014 Mar 11.

    PMID: 26663687DERIVED

Related Links

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2007

First Posted

September 10, 2007

Study Start

September 11, 2007

Primary Completion

April 3, 2008

Study Completion

April 3, 2008

Last Updated

October 31, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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/.

Shared Documents
STUDY PROTOCOL, SAP, CSR
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.
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.
More information

Locations

JP(5)