Clinical trial NCT00224133: The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Keywords: benign prostatic hyperplasia, alpha blocker
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 661
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)

Eligibility criteria: Inclusion Criteria:

* Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adverse Events
timeFrame: 9 months
Secondary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 9 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Culver City
country: United States
state: California
city: Fresno
country: United States
state: California
city: Irvine
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Laguna Woods
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Diego
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Melrose Park
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Fort Wayne
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Overland Park
country: United States
state: Kansas
city: Greenbelt
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: St. Joseph
country: United States
state: Michigan
city: Edina
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Lawrenceville
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Bay Shore
country: United States
state: New York
city: Garden City
country: United States
state: New York
city: Kingston
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Concord
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Bethany
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Lancaster
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Greer
country: United States
state: South Carolina
city: Mt. Pleasant
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Lakewood
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Watson Pharmaceuticals
name: Lawrence Hill, Pharm D, RPh
role: STUDY_DIRECTOR
References:
citation: 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.