EUCTR2010-020604-29-DE进行中（未招募）不适用
A Phase 3b,randomized,double-blind,placebo-controlled parallel-design study to evaluate the efficacy and safety of tadalafil coadministered with finasteride for 6 months in men with lower urinary tract symptoms(LUTS) and prostatic enlargement secondary to benign prostatic hyperplasia(BPH) - LVIW
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 646
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Subjects are eligible to be included in the study only if they meet all of the following criteria:
- •[1] Present with benign prostatic hyperplasia (BPH; also referred to as BPH-LUTS [lower urinary tract symptoms]) based on the disease diagnostic criteria at screening.
- •[2] Are men 45 years of age or older at screening.
- •[3] Provide signed informed consent at screening.
- •[4] Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments, including alpha blockers, additional 5 ARIs, antimuscarinics, PDE5 inhibitors, or herbal preparations, at any time during the study.
- •[6] Have not previously taken finasteride or dutasteride at any time prior to screening.
- •[7] Have not previously taken any other short-acting BPH therapy (including herbal preparations), OAB, or ED therapy for at least 4 weeks prior to the start of the placebo lead-in period, or any investigational BPH therapy with an anticipated prolonged effect, within 6 months of screening.
- •[8] Have LUTS with a total IPSS =13 at the start of the placebo lead-in period.
- •[9] 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 the start of the placebo lead-in period.
- •[10] Have prostate enlargement: prostate volume 30 cc or greater on TRUS at screening.
- •[11] Demonstrate compliance with study drug administration requirements during the placebo lead-in period by administering =70% of prescribed doses, confirmed by documentation that the subject returned =30% of prescribed doses at randomization.
- •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
排除标准
- •12] Prostate-specific antigen levels >10.0 ng/mL at screening.
- •13] Prostate-specific antigen levels =4.0 to =10.0 ng/mL at screening, if prostate malignancy has not been ruled out to the satisfaction of an urologist.
- •14] Bladder postvoid residual volume =300 mL by ultrasound determination at the start of the placebo lead-in period.
- •15] 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 of the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery. [d]Urologic malignancy or trauma.
- •16] Lower urinary tract instrumentation within 30 days of screening.
- •17] History of urinary retention or bladder stones within 6 months of screening
- •18] History of urethral obstruction due to stricture, valves, sclerosis, or tumor
- •19] Clinical evidence of any of the following bladder conditions:[a] Mullerian duct cysts [b] Atonic, decompensated, hypocontractile bladder [c] Detrusor-sphinctor dyssynergia [d] Intravesical obstruction [e] Interstitial cystitis
- •20] Clinical evidence of any of the following urinary tract conditions at screening: [a] Urinary tract infection [b] Urinary tract inflammation [c] Current antibiotic therapy for urinary tract infection. [d] Clinically significant microscopic hematuria
- •21] Clinical evidence of prostate cancer
- •22] Current neurologic disease or condition associated with neurogenic bladder
- •23] History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance of <30 mL/minute at screening, as calculated by the central laboratory using the Cockroft-Gault formula
- •24] Clinical evidence of severe hepatic impairment at screening.
- •25] History of any of the following cardiac conditions: [a] Angina requiring treatment with long-acting nitrates. [b] Angina requiring treatment with short-acting nitrates within 90 days of screening. [c] Unstable angina within 90 days of screening [d] Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention
- •26] History of any of the following coronary conditions within 90 days of screening: [a] Myocardial infarction [b] Coronary artery bypass graft surgery [c] Percutaneous coronary intervention
- •27] Any evidence of moderate to severe heart failure within 6 months of screening 28] Systolic blood pressure >160 or <90 mmHg, or diastolic blood pressure >100 or <50 mmHg at screening (if stress is suspected, retest under basal conditions), or malignant hypertension
- •29] Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study.
- •30] History of significant central nervous system injuries within 6 months of screening
- •31] History of drug, alcohol, or substance abuse within 6 months of screening.
- •32] Any condition that would interfere with the subject’s 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
- •33] Current treatment with nitrates, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone agonists/antagonists, anabolic steroids, antidiuretic hormone, atypical antipsychotics, cancer chemotherapy, serotonin norepinephrine reuptake inhibitors, or tricyclic antidepressants
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