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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00507455 |
A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in male subjects with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).
Condition | Intervention | Phase |
---|---|---|
Lower Urinary Tract Symptoms Bladder Outlet Obstruction |
Drug: solifenacin succinate Drug: tamsulosin hydrochloride Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-Administration of Solifenacin Succinate With 0.4 mg Tamsulosin Hydrochloride OCAS (TOCAS) Using Urodynamics in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO) |
Enrollment: | 222 |
Study Start Date: | June 2007 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
dose 1 solifenacin plus tamsulosin
|
Drug: solifenacin succinate
oral
Drug: tamsulosin hydrochloride
oral
|
2: Experimental
dose 2 solifenacin plus tamsulosin
|
Drug: solifenacin succinate
oral
Drug: tamsulosin hydrochloride
oral
|
3: Placebo Comparator |
Drug: placebo
oral
|
A 3 arm (2 active, 1 placebo) study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in male subjects with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc ( Sr Manager Clinical Trial Registries ) |
Study ID Numbers: | 905-CL-058 |
Study First Received: | July 25, 2007 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00507455 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; European Union: European Medicines Agency |
Lower Urinary Tract Symptoms Bladder Outlet Obstruction Treatment Solifenacin Succinate Tamsulosin hydrochloride |
Cystocele Urologic Diseases Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate |
Urinary Bladder Diseases Tamsulosin Urinary Bladder Neck Obstruction |
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Antineoplastic Agents Physiological Effects of Drugs Urethral Obstruction |
Adrenergic alpha-Antagonists Cholinergic Agents Pharmacologic Actions Muscarinic Antagonists Therapeutic Uses Urethral Diseases Adrenergic Antagonists |