Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms

Completed · Phase 3

Conditions studied: Urinary Bladder, Overactive

In brief

To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).

Key facts

Study ID

NCT00463541

Run by

Astellas Pharma Inc

People needed

2225

Starts

2004-06-01

Expected to finish

2005-04-01

Last updated by the study team

2014-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symptoms of OAB (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months.
• Patients may be included if they are on another OAB medication; however, patients must washout from other OAB medications for at least 7 days prior to receiving solifenacin succinate. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.

You may not qualify if…

• -Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
• Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
• Clinically significant outflow obstruction (benign prostatic hyperplasia)

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Decatur, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Oro Valley, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Buena Park, California, United States
• Study site — Corte Madera, California, United States
• Study site — Culver City, California, United States
• Study site — Fresno, California, United States
• Study site — Fullerton, California, United States
• Study site — Huntington Beach, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Modesto, California, United States
• Study site — Oceanside, California, United States
• Study site — Bay Minette, Alabama, United States

Full record on ClinicalTrials.gov

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