NCT01110590已完成1 期
Randomized, Double-blind, Placebo-controlled, Group-comparison, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administration of Different Doses of Vardenafil (2 Dose Strengths) and BAY60-4552 (4 Dose Strengths) Given Once-daily (od) Over 14 Days in Patients With Erectile Dysfunction (ED).
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 37
- 主要终点
- Adverse Event reporting
研究概览
简要总结
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552 and vardenafil will be given with patients with erectile dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The informed consent must be signed before any study specific tests or procedures are done
- •Male patients with a history of erectile dysfunction (ED) for at least 6 months, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" by the NIH consensus report
- •The diagnosis of 'Erectile dysfunction' has to be confirmed by a physician
- •Age: 18 to 70 years (inclusive) at the first screening examination
- •Ethnicity: White
- •Body mass index (BMI): equal to or above 18 and below 32 kg / m²
- •Confirmation of the patient's health insurance coverage prior to the first screening examination / visit
- •Ability to understand and follow study-related instructions
排除标准
- •Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- •Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- •Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- •Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the NIH consensus report 1993
- •History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to screening
- •Bleeding disorder
- •History of prostatectomy because of prostate cancer, including nerve-sparing techniques. Clarification: Any surgical procedures for the treatment of Benign Prostate Hypertrophy (BPH) are permitted, with the exception of cryosurgery, cryotherapy or cryoablation
- •Hereditary degenerative retinal disorders such as retinitis pigmentosa
- •History of loss of vision because of NAION (Bayer Study 12912), temporary or permanent loss of vision, including unilateral loss of vision
- •History of uni- or bilateral hearing loss
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY60-4552 + Vardenafil (Drug)
Arm 2
Experimental
干预措施: BAY60-4552 + Vardenafil (Drug)
Arm 3
Experimental
干预措施: BAY60-4552 + Vardenafil (Drug)
Arm 4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Event reporting
时间窗: up to 6 weeks
次要结局
- Plasma concentration of study drugs; Pharmacokinetic parameters: AUC, Cmax, AUC/D, Cmax;norm, Cmax/D, t1/2, tmax(Day 0, 6, 13)
- Plasma concentration of cyclic guanosine monophosphate (cGMP)(Day 0, 6, 13)
研究者
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