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A Study of YM178 in Patients With Symptomatic Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00527033
First received: September 6, 2007
Last updated: February 14, 2017
Last verified: February 2017

September 6, 2007
February 14, 2017
September 2007
April 2008   (Final data collection date for primary outcome measure)
Overactive bladder symptoms [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00527033 on ClinicalTrials.gov Archive Site
Overactive bladder symptoms (QOL) [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
A Study of YM178 in Patients With Symptomatic Overactive Bladder
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study in Patients With Symptomatic Overactive Bladder
Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability compared to placebo
To investigate the dose-response relationship of YM178 in terms of efficacy, safety and tolerability, and also the superiority of YM178 over placebo.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Urinary Bladder, Overactive
  • Drug: YM178
    Oral
  • Drug: Placebo
    Oral
  • Experimental: 1
    Oral
    Intervention: Drug: YM178
  • Experimental: 2
    Oral
    Intervention: Drug: YM178
  • Experimental: 3
    Oral
    Intervention: Drug: YM178
  • Placebo Comparator: 4
    Oral
    Intervention: Drug: Placebo
Yamaguchi O, Marui E, Igawa Y, Takeda M, Nishizawa O, Ikeda Y, Ohkawa S. Efficacy and Safety of the Selective β3 -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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
842
April 2008
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00527033
178-CL-045
No
Not Provided
Yes
Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Central Contact Astellas Pharma Inc
Astellas Pharma Inc
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP