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Study to Test the Efficacy and Safety of the Beta-3 Agonist YM178 in Patients With Symptoms of Overactive Bladder (ARIES)
This study has been completed.
Study NCT00662909   Information provided by Astellas Pharma Inc
First Received: April 17, 2008   Last Updated: May 20, 2009   History of Changes

April 17, 2008
May 20, 2009
April 2008
April 2009   (final data collection date for primary outcome measure)
  • Change from baseline to end of treatment in mean number of micturitions per 24 hours [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of treatment in mean number of incontinence episode per 24 hours [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662909 on ClinicalTrials.gov Archive Site
  • Change from baseline in mean volume voided per micturition [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urgency incontinence episodes per 24 hours [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urgency episodes (grade 3 and/or 4) per 24 hours [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
 
Study to Test the Efficacy and Safety of the Beta-3 Agonist YM178 in Patients With Symptoms of Overactive Bladder
A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist YM178 in Subjects With Symptoms of Overactive Bladder

The study is intended to test the efficacy, safety and tolerability of two doses of YM178 against placebo to treat patients with symptoms of overactive bladder

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Urinary Bladder, Overactive
  • Drug: YM178
  • Drug: Placebo
  • Experimental: Low dose
  • Experimental: Higher dose
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
2190
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is willing and able to complete the micturition diary and questionnaires correctly
  • Subject has symptoms of overactive bladder for >= 3 months
  • Subject must experience frequency of micturition on average >= 8 times per 24-hour period during the 3-day micturition diary period
  • Subject must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence during the 3-day micturition diary period

Exclusion Criteria:

  • Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
  • Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
  • Subject has an indwelling catheter or practices intermittent self-catheterization
  • Subject has diabetic neuropathy
  • Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
  • Subject receives non-drug treatment including electro-stimulation therapy
  • Subject has severe hypertension
  • Subject has a known or suspected hypersensitivity to YM178, other ß-AR agonists, or any of the other inactive ingredients
  • Subject has been treated with any investigational drug or device within 30 days
  • Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
  • Subject has serum creatinine of >150 μmol/L, or AST or ALT > 2x upper limit of normal range (ULN), or γ-GT > 3x ULN
  • Subject has a clinically significant abnormal ECG
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00662909
Sr Manager Clinical Trial Registry, Astellas Pharma Global Development
178-CL-047
Astellas Pharma Inc
 
Study Director: Use Central Contact Astellas Pharma Global Development
Astellas Pharma Inc
May 2009

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