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

INTERVENTION: Product Name: Tadalafil Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Tadalafil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Men with benign prostatic hyperplasia ; MedDRA version: 9.1 Level: LLT Classification code 10004446 Term: Benign prostatic hyperplasia PRIMARY OUTCOME: Main Objective: The primary objective of Study LVHJ is to evaluate the efficacy of tadalafil 5 mg daily for 12 weeks compared with placebo in improving the International Prostate Symptom Score (IPSS) in men with signs and symptoms of benign prostatic hyperplasia (BPH; also referred to as BPH‐LUTS [lower urinary tract symptoms]). Primary end point(s): Change from baseline after 12 weeks Secondary Objective: Evaluate the change of tadalafil 5 mg daily for 12 weeks compared with placebo daily for 12 weeks in the treatment of men with BPH‐LUTS as assessed by the following measures:IPSS storage, voiding and nocturnia?s subscore,IPSS Quality of Life Index,BPH Impact Index,Patient Global Impression of Improvement,Clinician Global Impression of Improvement,Voiding dribble diary‐To evaluate the change of tadalafil 5 mg daily compared with placebo after 1 week of treatment in men with BPH‐LUTS as assessed by the Modified IPSS‐To evaluate the change of tadalafil 5 mg compared with placebo after 4 weeks of treatment in men with BPH‐LUTS as assessed by the following measures:IPSS,BII. To examine the impact of tadalafil 5 mg for 12 weeks on erectile function in men with both BPH‐LUTS and erectile dysfunction as assessed by the IIEF EF Domain.To assess the safety of tadalafil 5 mg for 12 weeks in the treatment of men with BPH‐LUTS as examined by:Adverse events,Vital signs,Clinical laboratory tests,PRV INCLUSION CRITERIA: 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