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A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men. (VICTOR)
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00333112
First received: June 1, 2006
Last updated: September 17, 2014
Last verified: September 2014
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Purpose
A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.
| Condition | Intervention | Phase |
|---|---|---|
| Urinary Incontinence | Drug: solifenacin succinate Drug: tamsulosin Drug: placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Drug Information available for:
Succinic acid
Tamsulosin
Tamsulosin hydrochloride
Solifenacin succinate
U.S. FDA Resources
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Change in micturitions per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ]
Secondary Outcome Measures:
- Change in urgency episodes per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ]
| Enrollment: | 398 |
| Study Start Date: | May 2006 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: solifenacin succinate
Oral
Other Names:
Drug: tamsulosin
oral
|
| Placebo Comparator: 2 |
Drug: tamsulosin
oral
Drug: placebo
oral
|
Detailed Description:
A 2 arm study ( 1 Active, 1 Placebo) to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men
Eligibility| Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Symptoms of Overactive Bladder (OAB)
Exclusion Criteria:
- Current use of antimuscarinic therapy
- Evidence of a urinary tract infection
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00333112
Show 74 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333112
Show 74 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Astellas US Medical Information | Astellas Pharma US, Inc. |
More Information
Additional Information:
Publications:
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00333112 History of Changes |
| Other Study ID Numbers: |
905-UC-008 |
| Study First Received: | June 1, 2006 |
| Last Updated: | September 17, 2014 |
Keywords provided by Astellas Pharma Inc:
|
Treatment Outcome Urology Solifenacin succinate Urinary Incontinence |
Additional relevant MeSH terms:
|
Urinary Incontinence Enuresis Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms 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 |
ClinicalTrials.gov processed this record on July 27, 2017