EUCTR2007-004321-15-PT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia - LVHK
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 190
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
- •[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 informed consent document at Visit 1.
- •[4] Agree not to use any other approved or experimental pharmacologic treatments for BPH LUTS, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
- •[5] Have not taken the following treatments within the indicated duration:
- •[a] Finasteride or dutasteride therapy for at least 4 months prior to Visit 2.
- •[b] All other LUTS therapy (including herbal preparations) for at least 4 weeks prior to Visit 2.
- •[c] Any PDE5 inhibitor for at least 4 weeks prior to Visit 2.
- •[6] Have LUTS with a total IPSS greater than or equal to 13 under 1 of the following conditions:
- •[a] At Visit 1 if the subject does not require wash out of therapy for BPH LUTS.
- •[b] At Visit 2 if the subject requires wash out (4 weeks) of BPH LUTS therapy.
- •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
- •[1] PSA >10.0 ng/mL at Visit 1.
- •[2] PSA of 4.0 to 10.0 ng/mL inclusive at Visit 1 without documentation of a histologic biopsy of the prostate negative for cancer within 12 months of Visit 1.
- •[3] PVR measurement by ultrasound greater than or equal to 350 mL 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.
- •[d] Lower urinary tract malignancy or trauma.
- •[e] Chronic pelvic pain syndrome.
- •[5] Lower urinary tract instrumentation within 30 days of Visit 1.
- •[6] Any history of urinary retention or lower urinary tract stones within 6 months of Visit 1.
- •[7] History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
- •[8] Clinical evidence or history of any of the following bladder conditions:
- •[a] Bladder calculi.
- •[b] Intravesical obstruction.
- •[c] Atonic, decompensated, or hypocontractile bladder.
- •[d] Detrusor-sphincter dyssynergia.
- •[e] Interstitial cystitis.
- •[9] Evidence of any of the following urinary tract conditions:
- •[a] Urinary tract infection (UTI), defined as a positive urine culture at Visit 1, or a UTI that is not resolved at repeat testing following a course of antibiotic therapy.
- •[b] Urinary tract inflammation at Visit 1, defined as a positive result for leukocyte esterase from a urine dipstick or >5 white blood cells (WBC) per high powered field on urinalysis from a centrifuged, clean-catch, midstream urine specimen.
- •[c] Current antibiotic therapy for UTI at Visit 1.
- •[10] Clinical evidence of prostate cancer.
- •[11] Current neurologic disease or condition associated with neurogenic bladder.
- •[12] History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <50 mL/min at Visit 1 as calculated by the central laboratory using the Cockroft-Gault formula:
- •(140 - age [years]) × weight [kg] / (72 × serum creatinine [mg/dL])
- •[13] Active symptomatic hepatobiliary disease at Visit 1.
- •[14] 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 Visit 1.
- •[c] Unstable angina within 90 days of Visit 1.
- •[d] Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention.
- •[15] 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.
- •[16] Evidence of heart disease categorized as NYHA above or including Class III within 6 months of Visit 1.
- •[17] Systolic blood pressure >160 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at Visit 1 (if stress is suspected, retest under basal conditions), or malignant hypertension.
- •[18] Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study.
- •[19] History of significant central nervous system (CNS) injuries within 6 months of Visit 1.
- •[20] History of drug, alcohol, or substance abuse within 6 months of Visit 1.
- •[21] 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 interp
研究者
相似试验
进行中（未招募）
不适用
Study of the safety and effectiveness of two doses of investigational study drug EVP-6124 in subjects with Alzheimer’s DiseaseEUCTR2013-002653-30-ITEnVivo Pharmaceuticals, Inc.790
进行中（未招募）
不适用
Efficacy and Safety of REGN727/SAR236553 Versus Placebo in Patients with Heterozygous Familial Hypercholesterolemia Not Adequately Controlled with Their Lipid-Modifying TherapyEUCTR2012-001222-95-NLRegeneron Pharmaceuticals Inc.250
已完成
3 期
Once-A-Day Pregabalin For Partial SeizuresCTRI/2011/08/001976Pfizer Limited264
进行中（未招募）
1 期
Research study to evaluate SEP-4199 (the study drug) for the Treatment of Depressive Episodes in patients with Bipolar I Disorder.EUCTR2018-000103-16-BGSUNOVION PHARMACEUTICALS INC.341
进行中（未招募）
1 期
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With AlirocumabMedDRA version: 19.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersAcute coronary syndromeEUCTR2011-005698-21-EEsanofi-aventis Recherche & Développement18,600