Study to Test the Efficacy and Safety of the Beta-3 Agonist YM178 in Patients With Symptoms of Overactive Bladder - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00662909

Purpose

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

Condition	Intervention	Phase
Urinary Bladder, Overactive	Drug: YM178 Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence Urine and Urination

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	2190
Study Start Date:	April 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: YM178 low dose	Drug: YM178 Oral Other Name: mirabegron
Experimental: YM178 higher dose	Drug: YM178 Oral Other Name: mirabegron
Placebo Comparator: Placebo	Drug: Placebo Oral

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662909

Show 125 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	Sr Manager Clinical Trial Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier:	NCT00662909 History of Changes
Other Study ID Numbers:	178-CL-047
Study First Received:	April 17, 2008
Last Updated:	April 15, 2010
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Astellas Pharma Inc:

Overactive bladder (OAB)
Frequency
Micturition
Urgency

Urinary incontinence
Urinary urge incontinence
YM178

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012