Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lower Urinary Tract Symptoms; Bladder Outlet Obstruction
Intervention: solifenacin succinate (Drug); tamsulosin hydrochloride (Drug); placebo (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.
Summary
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).
Clinical Details
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)
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluate the urodynamic variables
Secondary outcome: Tolerability, safety, and efficacy of 2 doses of solifenacin succinate with tamsulosin hydrochloride
Detailed description:
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).
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Diagnosed with LUTS and BOO
- BOO indication by a BOOI ≥ 20
- Subject has a total IPPS score of ≥ 8 (Inclusion criteria for Baseline also)
Exclusion Criteria:
- History of urinary retention in preceding 12 months
- Current UTI or symptomatic and recurrent UTI of > 3 episodes within 12 months.
- Known clinical history or diagnosis of chronic inflammation, stone in bladder or
ureter, or other causes of outflow tract obstruction
- Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except
non-metastatic basal or squamous cell carcinoma of the skin that had been treated
successfully
- Clinically significant cardiovascular or cerebrovascular diseases within 6 months
prior to Visit 1
Locations and Contacts
Edegem 2650, Belgium
Kortrijk, Belgium
Prague, Czech Republic
Pilsen, Czech Republic
Olomouc, Czech Republic
Landshut, Germany
Muelheim, Germany
Hagenow, Germany
Aachen, Germany
Budapest, Hungary
Szeged, Hungary
Budapest, Hungary
Szekszard, Hungary
Warszawa, Poland
Myslowice, Poland
Bialystok, Poland
Szczecin, Poland
Homewood, Alabama 35209, United States
San Diego, California 92108, United States
San Bernardino, California 92404, United States
Long Beach, California 90806, United States
La Mesa, California 91942, United States
Middlebury, Connecticut 06762, United States
New Port Richey, Florida 34655, United States
Coeur d'Alene, Idaho 83814, United States
Iowa City, Iowa 52242, United States
Des Moines, Iowa 50309, United States
Watertown, Massachusetts 02472, United States
Las Vegas, Nevada 89148, United States
New York, New York 10021, United States
Greensboro, North Carolina 27403, United States
San Antonio, Texas 78229, United States
Austin, Texas 78705, United States
Charlottesville, Virginia 22908, United States
Additional Information
Starting date: June 2007
Ending date: July 2008
Last updated: June 5, 2008
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