drugset / Trial / NCT00678704

BAY38-9456 - Pivotal Trial for Diabetes Patient

NCT00678704

Phase 3 Completed 790 enrolled Bayer
RandomizedParallel-groupDouble-blindTreatment

Summary

The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.

Timeline

Start
2004-01
Primary completion
Completion
2004-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Vardenafil Small molecule 10 mg
Subject Vardenafil Small molecule 20 mg