A Study to Assess the Efficacy and Safety of Vardenafil in the Treatment of Male Patients With Erectile Dysfunction
Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to assess the efficacy together with safety of a
flexible regimen, for a period of twelve weeks, of three doses (5 mg, 10mg and 20mg) of Bay
38-9456, a phosphodiesterase type V inhibitor, in males with erectile dysfunction treated
with sildenafil in the previous <6 months .At entry, once the Inclusion and Exclusion
criteria are confirmed, the study medication will be administered for twelve weeks in an open
label design. Vardenafil will be administered, as needed, at a fix dose of 10 mg once daily
for the first four weeks of treatment. At the Investigators' discretion, on the basis of
efficacy and safety evaluations, the patients may, then, receive the same dose strength of
their assigned study medication or, at the subsequent clinic visit(s), the next lower dose (5
mg vardenafil) or the next higher dose (20 mg vardenafil) for the subsequent four weeks of
treatment. Previous dose level of vardenafil is either maintained, increased or decreased by
one step according to the three applicable dose strengths (5 mg, 10 mg, 20 mg ). The highest
dosage of vardenafil (20 mg) per day will not be exceeded. After twelve weeks of treatment,
the patient will be contacted twenty four hours following the last visit in order to collect
data concerning serious adverse events.