Urinary IncontinencePhase 4VICTORNCT00333112
A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.
A Phase 4 study testing solifenacin succinate and tamsulosin in people with Urinary Incontinence, run by Astellas Pharma Inc at 74 sites in United States.
Trial summary
A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- solifenacin succinate and tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 398 participants
- Where
- 74 sitesUnited States
- Study dates
- May 2006to Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of Overactive Bladder (OAB)
Who cannot join
- Current use of antimuscarinic therapy
- Evidence of a urinary tract infection
Trial locations and contacts
74 sites in 1 country.
74 sites in 1 country
United States74 sites
Study site
Atherton, California, 94027
Study site
Atlanta, Georgia, 30342
Study site
Aurora, Colorado, 80012
Study site
Bala-Cynwyd, Pennsylvania, 19004
Study site
Bensalem, Pennsylvania, 19020
Study site
Bethany, Oklahoma, 73008
Study site
Beverly Hills, California, 90211
Study site
Birmingham, Alabama, 35209
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Blue Ridge, Georgia, 30513
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Boston, Massachusetts, 02115
Study site
Buena, California, 90620
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Buena Park, California, 90320
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Camp Hill, Pennsylvania, 17011
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Carmichael, California, 95608
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Cincinnati, Ohio, 45212
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Cincinnati, Ohio, 45249
Study site
Clearwater, Florida, 33761
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Coeur d'Alene, Idaho, 83814
Study site
Concord, North Carolina, 28025
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Culver City, California, 90232
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Danbury, Connecticut, 06708
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Daytona Beach, Florida, 32114
Study site
Denver, Colorado, 80210
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Endwell, New York, 13760
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Evansville, Indiana, 47714
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Fort Myers, Florida, 33908
Study site
Fresno, California, 93720
Study site
Garden City, New York, 11530
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Grand Rapids, Michigan, 49544
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Hickory, North Carolina, 28601
Study site
Houston, Texas, 77024
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Jackson, Mississippi, 39202
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Lancaster, Pennsylvania, 17604
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Marietta, Georgia, 30060
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Mission Hills, California, 92084
Study site
Modesto, California, 95350
Study site
Mountain Lake Terrace, Washington, 98043
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Nashville, Tennessee, 37203
Study site
New Port Richey, Florida, 34652
Study site
New York, New York, 10016
Study site
New York, New York, 10021
Study site
Norman, Oklahoma, 73071
Study site
Ogden, Utah, 84403
Study site
Orange, California, 92869
Study site
Orchard Park, New York, 14127
Study site
Orlando, Florida, 32803
Study site
Orlando, Florida, 32806
Study site
Pembroke Pines, Florida, 33027
Study site
Pembroke Pines, Florida, 33028
Study site
Phoenix, Arizona, 85050
Study site
Poughkeepsie, New York, 12601
Study site
Rochester, New York, 14642
Study site
Roswell, Georgia, 30076
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Salt Lake City, Utah, 84121
Study site
San Bernardino, California, 92404
Study site
San Diego, California, 92108
Study site
Sandy Springs, Georgia, 30328
Study site
Shreveport, Louisiana, 71106
Study site
Simpsonville, South Carolina, 29681
Study site
Snellville, Georgia, 30078
Study site
Spokane, Washington, 99202
Study site
Springfield, Oregon, 97477
Study site
Tallahassee, Florida, 32308
Study site
Torrance, California, 90505
Study site
Tuscon, Arizona, 85712
Study site
Uniontown, Pennsylvania, 15401
Study site
Virginia Beach, Virginia, 23454
Study site
Watertown, Massachusetts, 02472
Study site
Wellington, Florida, 33414
Study site
West Orange, New Jersey, 07052
Study site
Wheat Ridge, Colorado, 80033
Study site
Wichita, Kansas, 67207
Study site
Winston-Salem, North Carolina, 27103
About this study
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
A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.
Read the 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
- Conditions
- Urinary Incontinence
- Being tested
- solifenacin succinate, tamsulosin, placebo
- Keywords
- Treatment Outcome, Urology, Solifenacin succinate, Urinary Incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacin succinateDrug
Also called Vesicare®, YM905
Oral
tamsulosinDrug
oral
placeboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: solifenacin succinate; Drug: tamsulosin |
| 2 | Placebo comparator | Not described Receives: Drug: tamsulosin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in micturitions per 24 hours from baseline to end of treatment
Measured: 18 weeks
Secondary outcomes (1)
Change in urgency episodes per 24 hours from baseline to end of treatment
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Astellas US Medical Information, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333112
- Sponsor's protocol ID
- 905-UC-008
- Acronym
- VICTOR
- Status last verified
- Sep 2014
- First submitted
- 1 Jun 2006
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. J Urol. 2009 Dec;182(6):2825-30. doi: 10.1016/j.juro.2009.08.023. Epub 2009 Oct 17.
PubMed 19837435
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00333112
- Acronym / sponsor ID
- VICTOR / 905-UC-008
- Conditions
- Urinary Incontinence
- Keywords
- Treatment Outcome, Urology, Solifenacin succinate, Urinary Incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 2 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: solifenacin succinate, Drug: tamsulosin |
| 2 | Placebo comparator | Drug: tamsulosin, Drug: placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptoms of Overactive Bladder (OAB)
Key exclusion criteria (2 listed)
- Current use of antimuscarinic therapy
- Evidence of a urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| solifenacin succinateAlso: Vesicare®, YM905Oral | Drug | 1 |
| tamsulosinoral | Drug | 1, 2 |
| placebooral | Drug | 2 |
Primary outcome
Change in micturitions per 24 hours from baseline to end of treatment
Time frame: 18 weeks
1 secondary outcome
Change in urgency episodes per 24 hours from baseline to end of treatment
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
- Background: PubMed 19837435Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. J Urol. 2009 Dec;182(6):2825-30. doi: 10.1016/j.juro.2009.08.023. Epub 2009 Oct 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astellas US Medical Information study director
Astellas Pharma US, Inc.
74 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing solifenacin succinate and tamsulosin in people with Urinary Incontinence, run by Astellas Pharma Inc at 74 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in micturitions per 24 hours from baseline to end of treatment (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00333112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.