EUCTR2006-004633-15-DE进行中（未招募）不适用
A randomized, double-blind, parallel group prospective pilot study to assess the effect of vardenafil on clinical outcome and on procedure duration after green light laser-ablation of the prostate gland for therapy of benign prostate hypertrophy (BPH)
适应症
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
- 60
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
- •Men with benign prostate hypertrophy (BPH) requiring surgical treatment. Irrespective of the study, the decision has been made by the investigator in conjunction with the patient that the surgery will be executed by means of Greenlight laser ablation.
- •Age up to 80 years.
- •Documented, dated, written Informed Consent.
- •Anesthesiologist´s agreement with swallowing one tablet approximately one hour before laser ablation commences.
- •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
- •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.
- •History of previous prostatectomy (transurethral intervention).
- •Patients suspect of prostate cancer.
- •Hereditary degenerative retinal disorders such as retinitis pigmentosa.
- •History of previous episode(s) of NAION or unilateral impairment of vision.
- •Any severe cardiovascular condition including unstable angina pectoris and congestive heart failure (NYHA III, IV).
- •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).
- •Severe chronic or acute liver disease (Child-Pugh B and C).
- •Chronic haematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma and leukemia.
- •Bleeding disorder.
- •Significant active peptic ulceration.
- •Resting hypotension (a resting systolic blood pressure of < 90 mm Hg) or hypertension (a resting systolic blood pressure > 170 mm Hg or a resting diastolic blood pressure > 110 mm Hg).
- •History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.
- •Symptomatic postural hypotension within 6 months of Visit 1.
- •Patients who subjectively or in the opinion of the investigator did not tolerate the initial dose of study medication well (10 mg of oral vardenafil or placebo as taken the evening before ablation of prostate) will be withdrawn from the study and not receive the second dose of study medication.
- •B) Concomitant medication
- •Subjects who are taking nitrates or nitric oxide donors.
- •Subjects who are taking oral or injectable androgens or anti-androgens.
- •Subjects who are taking the following potent inhibitors of cytochrome P450 3A4: HIV protease inhibitors such as ritonavir or indinavir, the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin.
- •Subjects who have received any investigational drug (including placebo) within 30 days of Visit 1.
- •Use of alpha-blockers during two days prior to first dosing of study medication and after ablation of prostate
- •Use of inhibitors of 5-alpha reductase after ablation of prostate
- •C) Abnormal laboratory values
- •Subjects with a serum creatinine clearance (calculated) < 30.0 mL/min.
- •Elevation of AST and/or ALT > 3 times the upper limit of normal.
- •D) Other exclusion criteria
- •Subjects with known hypersensitivity to Vardenafil, BAY 38-9456 or any component of the investigational medication.
- •Subjects who are illiterate or unable to understand subject diaries.
- •Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule of study procedures.
研究者
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