Benign Prostatic HyperplasiaPhase 3NCT00224133
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
A Phase 3 study testing Silodosin in people with Benign Prostatic Hyperplasia, run by Watson Pharmaceuticals at 79 sites in United States.
Trial summary
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Silodosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 661 participants
- Where
- 79 sitesUnited States
- Study dates
- Sep 2005to Apr 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010.
Who cannot join
- Medical conditions that would confound the efficacy evaluation.
- Medical conditions in which it would be unsafe to use an alpha-blocker.
- The use of concomitant drugs that would confound the efficacy evaluation.
- The use of concomitant drugs that would be unsafe with this alpha-blocker.
Trial locations and contacts
79 sites in 1 country.
79 sites in 1 country
United States79 sites
Study site
Albany, New York
Study site
Albuquerque, New Mexico
Study site
Anaheim, California
Study site
Aurora, Colorado
Study site
Austin, Texas
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Aventura, Florida
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Bay Shore, New York
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Bethany, Oklahoma
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Birmingham, Alabama
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Boston, Massachusetts
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Carmichael, California
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Charlotte, North Carolina
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Chicago, Illinois
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Cincinnati, Ohio
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Clearwater, Florida
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Concord, North Carolina
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Coral Gables, Florida
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Culver City, California
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Dallas, Texas
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Des Moines, Iowa
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Edina, Minnesota
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Evansville, Indiana
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Fort Wayne, Indiana
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Fresno, California
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Garden City, New York
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Greenbelt, Maryland
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Greer, South Carolina
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Huntsville, Alabama
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Irvine, California
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Jackson, Mississippi
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Kansas City, Missouri
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Kingston, New York
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La Jolla, California
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Laguna Woods, California
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Lakewood, Washington
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Lancaster, Pennsylvania
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Las Vegas, Nevada
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Lawrenceville, New Jersey
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Long Beach, California
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Madison, Wisconsin
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Manhasset, New York
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Marietta, Georgia
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Melrose Park, Illinois
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Milwaukee, Wisconsin
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Missoula, Montana
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Mt. Pleasant, South Carolina
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Myrtle Beach, South Carolina
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New Port Richey, Florida
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New York, New York
Study site
Newport Beach, California
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Norfolk, Virginia
Study site
Ocala, Florida
Study site
Orlando, Florida
Study site
Overland Park, Kansas
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Pensacola, Florida
Study site
Peoria, Illinois
Study site
Plantation, Florida
Study site
Portland, Oregon
Study site
Poughkeepsie, New York
Study site
Providence, Rhode Island
Study site
Saint Joseph, Michigan
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Salisbury, North Carolina
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Salt Lake City, Utah
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San Antonio, Texas
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San Bernardino, California
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San Diego, California
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Seattle, Washington
Study site
Staten Island, New York
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Tacoma, Washington
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Tampa, Florida
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Tarzana, California
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Torrance, California
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Tucson, Arizona
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Voorhees Township, New Jersey
Study site
Waterbury, Connecticut
Study site
West Palm Beach, Florida
Study site
Wheat Ridge, Colorado
Study site
Williamsville, New York
Study site
Winston-Salem, North Carolina
About this study
Official title: A Multi-Center, Open-Label Evaluation of the Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
Read the detailed description
This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance.
All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Silodosin
- Keywords
- benign prostatic hyperplasia, alpha blocker
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilodosinDrug
Also called Rapaflo
8 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Silodosin | Experimental | Silodosin 8 mg per day with food Receives: Drug: Silodosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.
Measured: 9 months
Secondary outcomes (1)
International Prostate Symptom Score (IPSS)
The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lawrence Hill, Pharm D, RPh, Study director, Watson Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224133
- Sponsor's protocol ID
- SI04011
- Status last verified
- Apr 2010
- First submitted
- 14 Sep 2005
- Last updated
- 27 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study. Urology. 2009 Dec;74(6):1318-22. doi: 10.1016/j.urology.2009.06.072. Epub 2009 Oct 7.
PubMed 19815265
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label Evaluation of the Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00224133
- Acronym / sponsor ID
- SI04011
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- benign prostatic hyperplasia, alpha blocker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 27 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
Detailed description
This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance.
All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silodosin | Experimental | Drug: SilodosinSilodosin 8 mg per day with food |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010.
Key exclusion criteria (4 listed)
- Medical conditions that would confound the efficacy evaluation.
- Medical conditions in which it would be unsafe to use an alpha-blocker.
- The use of concomitant drugs that would confound the efficacy evaluation.
- The use of concomitant drugs that would be unsafe with this alpha-blocker.
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 |
|---|---|---|
| SilodosinAlso: Rapaflo8 mg daily | Drug | Silodosin |
Primary outcome
Adverse Events
Time frame: 9 months
All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.
1 secondary outcome
International Prostate Symptom Score (IPSS)
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19815265Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study. Urology. 2009 Dec;74(6):1318-22. doi: 10.1016/j.urology.2009.06.072. Epub 2009 Oct 7.
- FDA approval summary and product labelLink provided by the sponsor.
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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.
Lawrence Hill, Pharm D, RPh study director
Watson Pharmaceuticals
79 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silodosin in people with Benign Prostatic Hyperplasia, run by Watson Pharmaceuticals at 79 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 4 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 27 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events (time frame: 9 months). 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 NCT00224133, 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 27 Apr 2010.