Trial Condition(s):

Erectile Dysfunction

BAY38-9456 (Vardenafil HCL tablet) in ED treatment for China registration.

Bayer Identifier:

10690

ClinicalTrials.gov Identifier:

NCT00668057

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

Inclusion Criteria
-  Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
 - Stable heterosexual relationship
Exclusion Criteria
- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
 - Nitrate use
 - Other exclusion criteria apply

Trial Summary

Enrollment Goal
624
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Beijing, China, 100191

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200001

Status
Completed
 
Locations

Investigative Site

HangZhou, China, 310003

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100034

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100044

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100853

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200040

Status
Completed
 

Trial Design