A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
Launched by WATSON PHARMACEUTICALS · Nov 18, 2008
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH and nocturia (\>=2 episodes per night)
- 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.
About Watson Pharmaceuticals
Watson Pharmaceuticals, now part of Teva Pharmaceuticals, is a global leader in the development and commercialization of generic and specialty pharmaceuticals. With a strong commitment to innovation and quality, Watson focuses on delivering affordable healthcare solutions while advancing therapeutic options across various medical fields. The company is dedicated to conducting rigorous clinical trials that adhere to the highest regulatory standards, ensuring the safety and efficacy of its products. Through its extensive research and development efforts, Watson Pharmaceuticals aims to improve patient outcomes and expand access to vital medications worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Diego, California, United States
West Des Moines, Iowa, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Bethany, Oklahoma, United States
Huntsville, Alabama, United States
Laguna Hills, California, United States
Aventura, Florida, United States
Clearwater, Florida, United States
Orlando, Florida, United States
Marietta, Georgia, United States
Sandy Springs, Georgia, United States
Coeur D'alene, Idaho, United States
Paducah, Kentucky, United States
Greenbelt, Maryland, United States
Troy, Michigan, United States
Missoula, Montana, United States
Las Vegas, Nevada, United States
Lawrenceville, New Jersey, United States
Bay Shore, New York, United States
Williamsville, New York, United States
Concord, North Carolina, United States
Salisbury, North Carolina, United States
Bala Cynwyd, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
Burien, Washington, United States
Patients applied
Trial Officials
Kim Caramelli, MS
Study Director
Watson Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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