NCT00730418已完成不适用
A Prospective Study for the Effects of Chronic Use of Doxazosin on Alpha 1-adrenergic Receptors in Men With Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Expression of alpha-1 adrenoceptor
研究概览
简要总结
In this study, we investigate the changes of the expression of alpha adrenergic receptor in the prostate tissue during 2-yr medication period in the man with benign prostatic hyperplasia. And we also evaluate the efficacy and safety of 24 mo-treatment with doxazosin (4mg, 8mg)
详细描述
To compare the expression of alpha-1 adrenergic receptors, we will use various methodologies such as
- Real-time RT-PCR
- Radioligand receptor binding
- Western blot
- Immunohistochemistry
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •50 yrs or greater
- •International prostatic symptom score >= 8
- •Maximal flow rate < 15mL/sec
- •baseline PSA 2.5-10 ng/mL
- •Pathologically proven BPH
- •No medication history for BPH
- •Able to give fully informed consent
排除标准
- •Previous use of alpha-blocker, 5-alpha reductase inhibitor
- •Previous surgery for BPH
- •Urologic cancer history
- •Urethral stricture
- •baseline PSA > 10ng/mL
- •BP < 90/70 mmHg
- •Orthotopic hypotension with syncope
- •Serum Cr > 2.0 mg/dl, alanine aminotransferase > 1.5 times of normal limit
- •Bacterial prostatitis within 1 year
- •Urinary tract infection(UTI) more than 2 times within 1 year
- •Active UTI or prostate biopsy within 1 month
- •Unable to void
- •Ped use because of incontinence
- •Hypersensitivity to alpha-blocker that include quinazoline
- •Unstable angina, Myocardial infarction, or cerebrovascular accident within 6 months
- •Neurogenic bladder dysfunction (ex. multiple sclerosis, Parkinson's disease, Spinal injury etc.)
- •Psychiatric problem
- •Alcohol abuse or other drug abuse history
- •Severe comorbidities unable to perform long-term trial
- •seems not to be appropriate to this study because of any other reasons
研究组 & 干预措施
doxazosin 4mg
Experimental
doxazosin 4mg group
干预措施: Doxazosin (Drug)
doxazosin 8mg
Experimental
doxazosin 8mg group
干预措施: Doxazosin (Drug)
结局指标
主要结局
Expression of alpha-1 adrenoceptor
时间窗: before treatment and 12mos and 24 mos after treatment
次要结局
- International Prostate Symptom Score, Patient perception of bladder condition, Maximal flow rate of urine, Postvoid Residual, Prostate volume, Serum PSA level, Adverse events(before treatment and 3mos, 12mos, and 24mos after treatment)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
2 期
Terazosin and Parkinson's Disease Extension StudySymptomatic Parkinson DiseaseREM Sleep Behavior DisorderPre-motor Parkinson's DiseaseNCT05109364Cedars-Sinai Medical Center15
已完成
不适用
Impact of Chronic Treatment by β1-adrenergic Antagonists on Nociceptive-Level (NOL) Index Variation After a Standardized Noxious Stimulus Under General AnesthesiaNociception During Anesthesia in Patients Taking β1-adrenergic Antagonist Chronic TreatmentNCT04060095Ciusss de L'Est de l'Île de Montréal33
Enrolling By Invitation
2 期
Cardiac Changes in Early Parkinson's Disease: a Follow Up StudyREM Sleep Behavior DisorderPre-motor Parkinson DiseaseSymptomatic Parkinson DiseaseNCT04218968Cedars-Sinai Medical Center15
终止
不适用
Observational Natural History Study of Autosomal Dominant Retinitis Pigmentosa (adRP)Retinitis PigmentosaNCT02926092Shire1
Enrolling By Invitation
不适用
A Prospective Cohort Study for Patients With Adrenal DiseasesAdrenal AdenomaAdrenal IncidentalomaPheochromocytomaPrimary HyperaldosteronismCushing SyndromeAdrenocortical CarcinomaNCT03474237Seoul National University Hospital1,500