Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction

Completed · Phase 2 · Has a placebo group

Conditions studied: Lower Urinary Tract Symptoms, Bladder Outlet Obstruction

In brief

A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).

Key facts

Study ID

NCT00507455

Run by

Astellas Pharma Inc

People needed

222

Starts

2007-06-01

Expected to finish

2008-08-01

Last updated by the study team

2014-08-06

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
• BOO indication by a Bladder Outlet Obstruction Index (BOOI) ≥ 20
• Patient has a total International Prostate Symptom Score (IPPS) score of ≥ 8 (Inclusion criteria for Baseline also)
• Patient had a maximum urinary flow rate of ≤ 12 mL/sec, with a voided volume of ≥ 120 mL during free flow in a representative assessment of uroflowmetry.

You may not qualify if…

• History of urinary retention in preceding 12 months
• Current urinary tract infection (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

Where it is running

• Study site — Homewood, Alabama, United States
• Study site — La Mesa, California, United States
• Study site — Long Beach, California, United States
• Study site — San Bernardino, California, United States
• Study site — San Diego, California, United States
• Study site — Middlebury, Connecticut, United States
• Study site — New Port Richey, Florida, United States
• Study site — Coeur d'Alene, Idaho, United States
• Study site — Des Moines, Iowa, United States
• Study site — Iowa City, Iowa, United States
• Study site — Watertown, Massachusetts, United States
• Study site — Las Vegas, Nevada, United States
• Study site — New York, New York, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Austin, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Edegem, Belgium
• Study site — Kortrijk, Belgium
• Study site — Olomouc, Czechia
• Study site — Pilsen, Czechia
• Study site — Prague, Czechia
• Study site — Aachen, Germany
• Study site — Hagenow, Germany
• Study site — Landshut, Germany

Full record on ClinicalTrials.gov

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