A prospective, randomized, double-blind, double-dummy, placebo- and active controlled, multicenter study assessing the efficacy and safety of the combination BAY 60 4552 / vardenafil compared to vardenafil (20 mg) for the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 inhibitors - ND

Bayer HealthCare AG0 个研究点目标入组 267 人开始时间: 2010年7月13日最近更新: 2012年3月19日

试验速览

暂无简介。

•Open-label run-in phase (first four weeks) •Written informed consent signed before any study-specific procedure •History of ED for at least 6 months prior to screening, defined as ``the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse``; the diagnosis of ED has to be confirmed by a physician •Stable, heterosexual relationship for at least 6 months prior to screening •Aged 18 to 64 years (inclusive) at the first screening examination •History of previous use of at least 1 marketed PDE5 inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose Double-blind treatment phase (last four weeks) •At least 4 attempts at sexual intercourse on 4 separate days during the open-label run-in phase with use of 20 mg vardenafil approximately 1 hour before attempting intercourse •IIEF EF score <17 •At least 50% of attempts at sexual intercourse during the open-label run-in phase were unsuccessful.
•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) no
•F.1.3.1 Number of subjects for this age range

•Contraindication to use of vardenafil •History of prostatectomy due to prostate cancer, including nerve-sparing techniques. •Concomitant use of adrenergic blockers •History of spinal cord injury •Resting hypotension, i.e. SBP <100 mmHg at rest •Moderate / severe hypertension, i.e. SBP >170 mmHg or DBP >110 mmHg at rest •Symptomatic orthostatic hypotension with a decrease in SBP >20 mmHg or in DBP >10 mmHg subsequent to change from the supine to standing position.

发起方