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Therapeutic Areas: Nephrology/Urology
Disease Category: Benign Prostatic Hyperplasia (Enlarged Prostate)

Trial Information

A Research Study to Evaluate the Efficacy, Dose Response, and Safety of Study Drug for 12 Weeks in Men with Benign Prostate Hyperplasia

This study is to investigate the efficacy, dose response, and safety of the study drug given once daily as the primary treatment for the signs and symptoms of benign prostate hyperplasia. Signs and symptoms include urinary frequency, urgency, intermittancy, nocturia, straining, incomplete emtying, and weak stream. This is a placebo controlled study and the objective is to test whether the study drug is superior to placebo in relieving the signs and symptoms of benign prostate hyperplasia over a 12 week treatment period.

Patient Inclusion Criteria

• Men age 45 or older with signs and symptoms of benign prostate hyperplasia, lower urinary tract symptoms and low urinary peak flow rate.

Patient Exclusion Criteria

• PSA greateer that 10
• PSA between 4 and 10 without documetation of a histologic biopsy of the prostate negative for cancer within the past 12 months
• History of pelvic surgery, pelvic radiation, or urinary tract malignancy or trauma
• Urinary tract infection or inflammation
• Prostate cancer
• Neurogenic Bladder
• Intravesicular Obstruction
• Hepatic impairment
• Significant renal insufficiency

For more information,

Southeastern Research Group, Inc.
2000 Centre Pointe Boulevard
Tallahassee, FL 32308
Phone: 850-201-0411
Fax: 850-205-2775
EMail: rschasst@seuc.com

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