A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia - LVHJ
- Conditions
- Men with benign prostatic hyperplasiaMedDRA version: 9.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasia
- Registration Number
- EUCTR2008-002841-21-IT
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 521
1.Present with benign prostatic hyperplasia (BPH; also referred to as BPH LUTS based on the disease diagnostic criteria at V1. 2.Are men 45 years of age or older at V1. 3.Provide signed informed consent at V1. 4.Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder, or erectile dysfunction treatments, including alpha blockers, 5-alpha reductase inhibitors (5 ARIs), antimuscarinics, phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at any time during the study. 5.Have not taken the following treatments within the indicated duration: Finasteride therapy for at least 3 months prior to V2,Dutasteride therapy for at least 6 months prior to V2,All other BPH therapy for at least 4 weeks prior to V2.OAB therapy for at least 4 weeks prior to V2, ED therapy for at least 4 weeks prior to V2. 6.Have LUTS with a Total International Prostate Symptom Score (IPSS) >/=13 at V2. 7.Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of >/=4 to /=70% of prescribed doses, confirmed by documentation that the subject returned 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
9.PSA>10.0 ng/mL at V1.10.PSA >/=4.0 to /=300 mL by ultrasound determination at V1.12.History of any of the following pelvic conditions:Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection;Pelvic radiotherapy;Any pelvic surgical procedure of the urinary tract, including minimally invasive BPH LUTS therapies and penile implant surgery.Lower urinary tract malignancy or trauma.13.Lower urinary tract instrumentation (including prostate biopsy) within 30 days of V1.14.History of urinary retention or lower urinary tract (bladder) stones within 6 months of V1.15.History of urethral obstruction due to stricture, valves, sclerosis, or tumor.16.Clinical evidence of any of the following bladder conditions:Mullerian duct cysts,Atonic, decompensated, or hypocontractile bladder,Detrusor-sphincter dyssynergia, Intravesical obstruction,Interstitial cystitis.17.Clinical evidence of any of the following urinary tract conditions at V1:Urinary tract infection,Urinary tract inflammation,Current antibiotic therapy for urinary tract infection.18.Clinical evidence of prostate cancer.19Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson?s disease, multiple sclerosis).20.History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <30 mL/minute at V121.Clinical evidence of severe hepatic impairment at V1.22.History of any of the following cardiac conditions:Angina requiring treatment with long-acting nitrates,Angina requiring treatment with short-acting nitrates within 90 days of V1,Unstable angina within 90 days of V1,Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention.23.History of any of the following coronary conditions within 90 days of V1:Myocardial infarction,Coronary artery bypass graft surgery,Percutaneous coronary intervention. 24.Any evidence of heart disease (New York Heart Association [NYHA] >/= Class III within 6 months of V1.25.Systolic blood pressure >160 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at V1 or malignant hypertension.26.Scheduled or planned surgery during the course of the study. 27.History of significant central nervous system injuries within 6 months of V1.28.History of drug, alcohol, or substance abuse within 6 months of V1.29.Any condition that would interfere with subject ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results.30.Current treatment with nitrates, androgens, antiandrogens, estrogens, luteinizing hormone releasing hormone agonists/antagonists, or anabolic steroids.31.Current systemic treatment with any of the following:Potent cytochrome P450 3A4 (CYP3A4) inhibitors,CYP3A4 inducer rifampicin.32.Glycosylated hemoglobin >9% at V1. 33.Known or suspected hypersensitivity to tadalafil or any study drug components.34.Are investigator site personnel directly affiliated with this study and/or their immediate families.35.Are Lilly employees.36.Previously completed or withdrawn from this study or any other study investigating tadalafil.37.Have received treatment within the last 30 days with a drug that has not received regulatory approval
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method