A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men. (VICTOR)
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ClinicalTrials.gov Identifier: NCT00333112 |
Recruitment Status :
Completed
First Posted : June 2, 2006
Last Update Posted : September 18, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Incontinence | Drug: solifenacin succinate Drug: tamsulosin Drug: placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 398 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Safety and Efficacy, Phase 4 Study of VESIcare® (Solifenacin Succinate) or Placebo in Combination With Tamsulosin HCl for the Treatment of Residual OAB Symptoms of Urgency and Frequency in Men VICTOR: VESIcare® In Combination With Tamsulosin in OAB Residual Symptoms |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | January 2007 |
Actual Study Completion Date : | January 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: solifenacin succinate
Oral
Other Names:
Drug: tamsulosin oral |
Placebo Comparator: 2 |
Drug: tamsulosin
oral Drug: placebo oral |
- Change in micturitions per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ]
- Change in urgency episodes per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ]

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Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Symptoms of Overactive Bladder (OAB)
Exclusion Criteria:
- Current use of antimuscarinic therapy
- Evidence of a urinary tract infection

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): NCT00333112

Study Director: | Astellas US Medical Information | Astellas Pharma US, Inc. |
Publications:
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00333112 |
Other Study ID Numbers: |
905-UC-008 |
First Posted: | June 2, 2006 Key Record Dates |
Last Update Posted: | September 18, 2014 |
Last Verified: | September 2014 |
Treatment Outcome Urology Solifenacin succinate Urinary Incontinence |
Urinary Incontinence Enuresis Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders Tamsulosin Solifenacin Succinate |
Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |