Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder (VERSUS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00454740 |
Recruitment Status
:
Completed
First Posted
: April 2, 2007
Last Update Posted
: September 18, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Bladder, Overactive | Drug: solifenacin succinate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 441 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients Who Wish to Switch From Detrol LA® (Tolterodine Tartrate Extended Release) for the Treatment of Overactive Bladder Symptoms Versus: VESIcare® Efficacy and Research Study US |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | August 2005 |
Actual Study Completion Date : | August 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: solifenacin succinate
Oral
Other Name: VESIcare(R), YM905
|
- Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome. [ Time Frame: Weeks 1, 4, 8 and 12 ]
- To assess the improvement in urge incontinence, frequency,nocturia, and urgency [ Time Frame: Weeks 1, 4, 8 and 12 ]
- Number of patients satisfied with treatment [ Time Frame: Weeks 1, 4, 8 and 12 ]
- Assessment of efficacy [ Time Frame: End of study ]
- Evaluation of the safety and tolerability [ Time Frame: Baseline to end of study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with OAB who have been treated with tolterodine tartrate extended release for at least 4 weeks immediately preceding entry into the study, and wish to switch to solifenacin succinate due to lack of sufficient improvement in urgency episodes.
- Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to Screening and is continued throughout the study.
- At least 3 urinary urgency episodes/24 hours while receiving tolterodine tartrate extended release documented in a 3-day patient diary in the pre-washout assessments on tolterodine tartrate extended release with or without urge incontinence described as OAB syndrome.
- Prior to treatment with tolterodine tartrate extended release, patients must have had OAB syndrome for 3 or more months.
Exclusion Criteria:
- Previous treatment with darifenacin
- Treatment with tolterodine tartrate extended release for less than 4 weeks prior to enrollment in the study.
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
- Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones.
- Clinically significant outflow obstruction as determined by the Investigator
- Uncontrolled narrow angle glaucoma, urinary or gastric retention.
- All patients with severe renal or hepatic impairment will be excluded
- Patients with chronic severe constipation or history of diagnosed gastrointestinal obstructive disease.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454740

Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00454740 History of Changes |
Other Study ID Numbers: |
905-UC-006 |
First Posted: | April 2, 2007 Key Record Dates |
Last Update Posted: | September 18, 2014 |
Last Verified: | September 2014 |
Keywords provided by Astellas Pharma Inc:
Urinary Bladder, Overactive Urgency VESIcare® Solifenacin succinate |
Additional relevant MeSH terms:
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Solifenacin Succinate Tolterodine Tartrate |
Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |