A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia - ND

ELI LILLY0 sites1,265 target enrollmentJuly 2, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: ELI LILLY
Enrollment: 1265
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 2, 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

ELI LILLY

Eligibility Criteria

Inclusion Criteria

•\[1] Present with BPH\-LUTS based on the disease diagnostic criteria at Visit 1\. \[2] Are men 45 years of age or older at Visit 1\. \[3] Provide signed ICD at Visit 1\. \[4] Agree not to use any other approved or experimental pharmacologic BPH or ED treatments or herbal preparations at any time during the study. \[5] Have not taken the following treatments within the indicated duration:\[a] Finasteride therapy for at least 3 months prior to Visit 2\.\[b] Dutasteride therapy for at least 12 months prior to Visit 2\.\[c] All other BPH therapy (including herbal preparations) for at least 4 weeks prior to Visit 2\.\[d] ED therapy for at least 4 weeks prior to Visit 2\. \[6] Have LUTS with a total IPSS \>\=13 at Visit 2\. \[7] Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of \>\=4 to \<\=15 mL/second (from a prevoid total bladder volume \[assessed by ultrasound] of \>\=150 to \<\=550 mL and a minimum voided volume of 125 mL) at Visit 2\. \[8] Demonstrate compliance with study drug administration requirements during the placebo run\-in period by administering \>\=70% of prescribed doses, confirmed by documentation that the subject returned \<\=30% of prescribed doses at Visit 3\.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•\[1] PSA \>10\.0 ng/mL at Visit 1\. \[2] PSA \>\=4\.0 to \<\=10\.0 ng/mL at Visit 1 without documentation of a histologic biopsy of the prostate negative for cancer within 12 months of Visit 1\. \[3] Bladder PVR \>\=300 mL by ultrasound determination at Visit 1\. \[4] History of any of the following pelvic conditions:\[a] Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection.\[b] Pelvic radiotherapy.\[c] Any pelvic surgical procedure on the urinary tract, including penile implant surgery.\[d] Lower urinary tract malignancy or trauma. \[5] Lower urinary tract instrumentation (including prostate biopsy) within 30 days of Visit 1\. \[6] History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1\. \[7] History of urethral obstruction due to stricture, sclerosis, or tumor. \[8] Clinical evidence of any of the following bladder conditions:\[a] Mullerian duct cysts. \[b] Bladder calculi.\[c] Atonic or hypocontractile bladder.\[d] Detrusor\-sphincter dyssynergia. \[9] Clinical evidence of any of the following urinary tract conditions at Visit 1:\[a] Urinary tract infection.\[b] Urinary tract inflammation.\[c] Current antibiotic therapy for urinary tract infection. \[10] History of intravesical obstruction. \[11] Clinical evidence of prostate cancer. \[12] Current neurologic disease or condition associated with neurogenic bladder. \[13] History of significant renal insufficiency. \[14] Clinical evidence of hepatic impairment at Visit 1\. \[15] History of Angina or positive cardiac stress test. \[16] History of any of the following coronary conditions within 90 days of Visit 1:\[a] Myocardial infarction.\[b] Coronary artery bypass graft surgery. \[c] Percutaneous coronary intervention (for example, angioplasty or stent placement). \[17] Any evidence of heart disease within 6 months of Visit 1\. \[18] Systolic blood pressure \>180 or \<90 mm Hg or diastolic blood pressure \>110 or \<50 mm Hg at Visit 1 (if stress is suspected, retest under basal conditions), or malignant hypertension. \[19] Scheduled or planned surgery (or any procedure requiring general anesthesia) during the course of the study. \[20] History of significant central nervous system (CNS) injuries within 6 months of Visit 1\. \[21] History of drug, alcohol, or substance abuse within 6 months of Visit 1\. \[22] Current treatment with nitrates, cancer chemotherapy, androgens, antiandrogens,estrogens, LHRH agonists/antagonists, or anabolic steroids. \[23] Current systemic treatment with a potent cytochrome P450 3A4 inhibitor \[24] Glycosylated hemoglobin (HbA1c) \>11% at Visit 1\. \[25]History of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.