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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00801944 |
Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.
Condition | Intervention | Phase |
---|---|---|
Urinary Bladder, Overactive |
Drug: Solifenacin succinate Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-Controlled, Double-Blind Trial |
Enrollment: | 973 |
Study Start Date: | April 2004 |
Study Completion Date: | October 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: Experimental
Solifenacin succinate 5/10mg
|
Drug: Solifenacin succinate
oral
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II: Experimental
Placebo
|
Drug: Placebo
oral
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Central Contact | Astellas Pharma Europe BV |
Responsible Party: | Astellas Pharma Europe BV ( Disclosure Office Europe ) |
Study ID Numbers: | 905-EC-002 |
Study First Received: | December 2, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00801944 History of Changes |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; Czech Republic: State Institute for Drug Control; Germany: Ministry of Health; Egypt: Ministry of Health and Population; Spain: Ministry of Health; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Greece: Ministry of Health and Welfare; Hungary: National Institute of Pharmacy; Italy: National Institute of Health; Poland: Ministry of Health; Portugal: Ethics Committee for Clinical Research; Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control |
Overactive Bladder |
Muscarinic Antagonists Signs and Symptoms Urinary Bladder, Overactive Neurotransmitter Agents Cystocele |
Cholinergic Antagonists Urologic Diseases Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Urinary Bladder Diseases Cholinergic Agents |
Urinary Bladder, Overactive Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Urinary Bladder Diseases Physiological Effects of Drugs Cholinergic Agents |
Pharmacologic Actions Muscarinic Antagonists Urological Manifestations Signs and Symptoms Urologic Diseases Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate |