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NCT00507455 · ClinicalTrials.gov registry record · Phase 2
Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
A Phase 2 study of Lower Urinary Tract Symptoms and Bladder Outlet Obstruction, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 222
- Enrollment target
- 20
- Study locations
NCT00507455: Completed Phase 2 study of Lower Urinary Tract Symptoms and Bladder Outlet Obstruction, sponsored by Astellas Pharma.
NCT00507455 is a Phase 2 study of Lower Urinary Tract Symptoms and Bladder Outlet Obstruction that has completed, run by Astellas Pharma. The registered enrollment target is 222 participants, below the 740-participant average among 21 other Lower Urinary Tract Symptoms trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00507455, a Phase 2 study of Lower Urinary Tract Symptoms and Bladder Outlet Obstruction, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 222 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry.
Conditions Studied
Interventions
- DRUG solifenacin succinate
- DRUG tamsulosin hydrochloride
- DRUG Placebo to solifenacin
- DRUG Placebo to tamsulosin
Study Locations (20)
California
- - La Mesa
- - Long Beach
- - San Bernardino
- - San Diego
Other
- - Edegem
- - Kortrijk
- - Olomouc
Iowa
- - Des Moines
- - Iowa City
Texas
- - Austin
- - San Antonio
Alabama
- - Homewood
Connecticut
- - Middlebury
Florida
- - New Port Richey
Idaho
- - Coeur d'Alene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
What the finished NCT00507455 record still lists
NCT00507455 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, below the 740-participant average among 21 other Lower Urinary Tract Symptoms trials with a reported enrollment target (70% lower).
The record links to 2 conditions, with Lower Urinary Tract Symptoms appearing as the primary indexed condition, and to 4 interventions - of which solifenacin succinate is the first listed.
NCT00507455 names 20 study sites across 13 states, led by California, Other, Iowa.
Frequently Asked Questions
What is clinical trial NCT00507455 about?
NCT00507455 is a clinical study titled "Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction". 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).
What is the current status of trial NCT00507455?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2007-06. Estimated completion is 2008-08.
What conditions does trial NCT00507455 study?
This clinical trial studies the following conditions: Lower Urinary Tract Symptoms, Bladder Outlet Obstruction.
What interventions are being tested in trial NCT00507455?
The interventions under investigation include: solifenacin succinate (DRUG), tamsulosin hydrochloride (DRUG), Placebo to solifenacin (DRUG), Placebo to tamsulosin (DRUG).
Who is sponsoring clinical trial NCT00507455?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00507455 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lower Urinary Tract Symptoms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00507455's enrollment target sits among peer trials
222 6th of 21 higher than 16 of 21 other Lower Urinary Tract Symptoms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lower Urinary Tract Symptoms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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