Status:
COMPLETED
Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
ICOS Corporation
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men w...
Eligibility Criteria
Inclusion
- Males, 45 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
- Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study
- Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 2.
- Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.
Exclusion
- History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study
- History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor.
- History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
- Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.
- Nitrate use
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
1058 Patients enrolled
Trial Details
Trial ID
NCT00384930
Start Date
August 1 2006
End Date
October 1 2008
Last Update
September 2 2009
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Greenwood, Indiana, United States