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BAY38-9456 - Pivotal Trial for Diabetes Patient

NCT00678704 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 790

Last updated 2014-12-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Levitra (Vardenafil, BAY38-9456)

BAY 38-9456 10 mg tablet prior to intercourse on demand

DRUG

Levitra (Vardenafil, BAY38-9456)

BAY 38-9456 20 mg tablet prior to intercourse on demand

DRUG

Placebo

Placebo tablet prior to intercourse on demand

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Completion
2004-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00678704 on ClinicalTrials.gov