drugset / Trial / NCT01110590

Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552

NCT01110590

Phase 1 Completed 37 enrolled Bayer
RandomizedParallel-groupQuadruple-blind

Summary

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.

Timeline

Start
2010-01
Primary completion
2010-04
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject BAY60-4552 Unknown 5.25 mg
Subject BAY60-4552 Unknown 21 mg
Subject Vardenafil Small molecule 140 mg
Subject Vardenafil Small molecule 280 mg

Indications