Benigne Prostatic Hyperplasia MedDRA version: 8.0 Level: LLT Classification code 10004446
Conditions
Interventions
Trade Name: Levitra 10 mg Filmtabletten
Product Name: Levitra 10 mg Filmtabletten
Product Code: Bay 38-9456
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Vardenafil-HCL
CAS Number: 2247
Sponsors
Bayer Healthcare AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: At SCREENING - Males 45 to (including) 64 years of age - Lower urinary tract symptoms (LUTS) for >= 6 months - Documented, signed and dated written Informed Consent At RANDOMIZATION - IPSS total score >= 12 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At SCREENING A) Previous or Current Medical Conditions - Any unstable medical, psychiatric, or substance abuse disorder that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study - Spinal cord injury - Hereditary degenerative retinal disorders such as retinitis pigmentosa - History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C - Severe chronic or acute liver disease, including history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment - Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia - Clinically significant bleeding disorder - Significant active peptic ulceration - Prostatitis (chronic or current) - Known vesical tumors (benign or malign) - History of prostate cancer - Clinically significant stricture of bladder or urethra - History of or current urinary retention - History of clinically significant pelvic trauma or surgery - Known stones or concrements in the urinary tract - Neurological diseases or symptoms that may interfere with voiding - Any underlying cardiovascular condition including unstable angina pectoris that would preclude sexual activity - History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months - Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 100 bpm) - Current macro-hematuria - Resting hypotension (a resting systolic blood pressure of 170 mm Hg or a resting diastolic blood pressure >110 mm Hg) - Symptomatic postural hypotension within 6 months of Visit 1 - History of malignancy within the past 5 years (other than squamous or basal cell skin cancer) - Life expectancy = 3 ng/ml - Creatinine Clearance = 3 x the Upper Limit of Normal - Micro-hematuria (assessment by means of dipsticks) D) Other Exclusions - Known hypersensitivity to vardenafil, Bay 38-9456 (also known as SB-782528) or any component of the investigational medication - Illiterate or are unable to understand the questionnaires - Unwilling or unable to complete the questionnaires At RANDAMIZATION - All SCREENING Exclusion Criteria - Residual urine volume > 100 mL (sonographic assessment) - Micro- or macro-hematuria - If alpha-blockers were withdrawn at Visit 1 (Screening): significant (in the opinion of the investigato
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy, tolerability and safety of vardenafil (10 mg BID) versus placebo in the two month treatment of men with symptomatic BPH.;Secondary Objective: Secondary variables of efficacy are - the Post-void residual urine volume (PVR), - the Quality-of-life questionnaire 9 (QoL-9) and - the erectile function domain of the International Index of Erectile Function (IIEF-EF). ;Primary end point(s): Primary endpoints of efficacy are - the International Prostate Symptoms Score (IPSS) and - the maximum urinary flow (Q max) which will be tested in a hierarchical order. | — |
Countries
Germany
Outcome results
None listed