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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00688688 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 2500 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
low dose
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Drug: YM178
Oral
|
2: Experimental
higher dose
|
Drug: YM178
Oral
|
3: Active Comparator |
Drug: Tolterodine 4 ng
Oral
|
Patients who completed 178-CL-046 or 178-CL-047 or new patients could be enrolled in this study if eligible.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Medical Clinical Development Department | 31-71-54-5745 |
Study Director: | Central Contact | Astellas Pharma Europe BV |
Responsible Party: | Astellas Pharma Europe BV ( Disclosure Office Europe ) |
Study ID Numbers: | 178-CL-049, EudraCT number 2007-001452-39 |
Study First Received: | May 29, 2008 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00688688 |
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: National Agency for Medicines; 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 |
Overactive Bladder Frequency Micturition |
Urgency Urinary incontinence Urinary urge incontinence |
Signs and Symptoms Urinary Bladder, Overactive Cystocele Urologic Diseases |
Urinary Bladder Diseases Urinary Incontinence Urinary Incontinence, Urge Tolterodine |
Muscarinic Antagonists Urological Manifestations Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Cholinergic Antagonists Physiological Effects of Drugs Cholinergic Agents Pharmacologic Actions |