Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Astellas Pharma Inc |
---|---|
Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00802373 |
Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.
Condition | Intervention | Phase |
---|---|---|
Urinary Bladder, Overactive |
Drug: Solifenacin succinate Drug: Tolterodine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Solifenacin in a Flexible Dose Regimen With Tolterodine as an Active Comparator in a Double-Blind, Double-Dummy, Randomised Overactive Bladder Symptom Trial |
Enrollment: | 1355 |
Study Start Date: | July 2003 |
Study Completion Date: | October 2004 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: Experimental
Solifenacin succinate 5/10mg
|
Drug: Solifenacin succinate
oral
|
II: Experimental
Tolterodine 4mg
|
Drug: Tolterodine
Oral
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At study entry:
At randomization:
Patient must experience at least one of the following symptoms during the 3 day micturition diary period:
Exclusion Criteria:
At study entry:
At randomization:
Study Chair: | Central Contact | Astellas Pharma Europe BV |
Responsible Party: | Astellas Pharma Europe BV ( Disclosure Office Europe ) |
Study ID Numbers: | 905-EC-001 |
Study First Received: | December 2, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00802373 History of Changes |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; Belarus: Ministry of Health; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Germany: Ministry of Health; 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; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Sweden: Medical Products Agency; Slovakia: State Institute for Drug Control; Ukraine: Ministry of Health |
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 Tolterodine |
Urinary Bladder, Overactive Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urinary Bladder Diseases 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 Tolterodine |