drugset / Trial / NCT00678704
BAY38-9456 - Pivotal Trial for Diabetes Patient
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vardenafil | Small molecule | 10 mg | — |
| Subject | Vardenafil | Small molecule | 20 mg | — |