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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00689104 |
The study is intended to test efficacy, safety and tolerability of two doses of YM178 against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.
Condition | Intervention | Phase |
---|---|---|
Urinary Bladder, Overactive |
Drug: YM178 Drug: Tolterodine 4 mg Drug: Placebo |
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, Placebo and Active Controlled, Multi-Center Study to Assess the Efficacy and Safety of the Beta-3 Agonist YM178 in Subjects With Symptoms of Overactive Bladder |
Estimated Enrollment: | 2160 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
low dose
|
Drug: YM178
Oral
|
2: Experimental
higher dose
|
Drug: YM178
Oral
|
3: Active Comparator |
Drug: Tolterodine 4 mg
Oral
|
4: Placebo Comparator |
Drug: Placebo
Oral
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Medical Clinical Developmental 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-046, EudraCT number 2007-001451-19 |
Study First Received: | May 29, 2008 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00689104 |
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 |
Overactive bladder (OAB) Frequency Micturition Urgency |
Urinary incontinence Urinary urge incontinence YM178 |
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 |