Study to Test the Long Term Safety and Efficacy 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:	NCT00688688

Purpose

The study is intended to test the safety, tolerability, efficacy of two doses of long term treatment of YM178 in patients with symptoms of overactive bladder and secondly to compare these with active comparator.

Condition	Intervention	Phase
Urinary Bladder, Overactive	Drug: YM178 Drug: Tolterodine 4 ng	Phase 3

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 Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy 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

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Assess incidence and severity of treatment emerged adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline in mean number of micturitions/24h. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Change from baseline in mean number of incontinence episodes/24 h [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Change from baseline in mean volume voided per micturition. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment:	2452
Study Start Date:	April 2008
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1: low dose	Drug: YM178 Oral Other Name: mirabegron
Experimental: 2: higher dose	Drug: YM178 Oral Other Name: mirabegron
Active Comparator: 3. Tolterodine	Drug: Tolterodine 4 ng Oral

Detailed Description:

Patients who completed 178-CL-046 or 178-CL-047 or new patients could be enrolled in this study if eligible.

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 experiences 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 tolterodine, other anticholinergics, YM178, other ß-AR agonists, or lactose or any of the other inactive ingredients
Subject has been treated with any investigational drug or device within 30 days (90 days in the UK for all clinical studies except 178-CL-046)
Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
Subject has serum creatinine >150 umol/L, AST and/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: NCT00688688

Show 308 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma Europe BV

More Information

No publications provided

Responsible Party:	Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier:	NCT00688688 History of Changes
Other Study ID Numbers:	178-CL-049, 2007-001452-39
Study First Received:	May 29, 2008
Last Updated:	May 10, 2011
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Office for Safety in Health Care Belarus: Ministry of Health Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Bulgaria: Bulgarian Drug Agency Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Hungary: National Institute of Pharmacy Iceland: Icelandic Medicines Control Agency Ireland: Irish Medicines Board Italy: Ethics Committee Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Norway: Norwegian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: National Pharmacy and Medicines Institute Romania: National Medicines Agency Russia: Ministry of Health and Social Development of the Russian Federation Slovakia: State Institute for Drug Control South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Swissmedic Ukraine: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency Canada: Health Canada Morocco: Ministry of Public Health

Keywords provided by Astellas Pharma Inc:

Overactive Bladder
Frequency
Micturition

Urgency
Urinary incontinence
Urinary urge incontinence

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tolterodine
Muscarinic Antagonists

Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012