A Study of YM178 in Patients With Symptomatic Overactive Bladder

NCT ID: NCT00527033

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

842 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-11

Study Completion Date

2008-04-03

Brief Summary

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

Detailed Description

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To investigate the dose-response relationship of YM178 in terms of efficacy, safety and tolerability, and also the superiority of YM178 over placebo.

Conditions

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Urinary Bladder, Overactive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Oral

Group Type EXPERIMENTAL

YM178

Intervention Type DRUG

Oral

2

Oral

Group Type EXPERIMENTAL

YM178

Intervention Type DRUG

Oral

3

Oral

Group Type EXPERIMENTAL

YM178

Intervention Type DRUG

Oral

4

Oral

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral

Interventions

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YM178

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients over 20 years suffering from overactive bladder

Exclusion Criteria

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

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Chūbu, , Japan

Site Status

Hokkaido, , Japan

Site Status

Kansai, , Japan

Site Status

Kanto, , Japan

Site Status

Kyusyu, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 26663687 (View on PubMed)

Related Links

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https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=166

Link to results on Astellas Clinical Study Results website

Other Identifiers

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178-CL-045

Identifier Type: -

Identifier Source: org_study_id

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