Status:
COMPLETED
BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
Lead Sponsor:
Bayer
Conditions:
Erectile Dysfunction
Eligibility:
MALE
22+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT00668057
Start Date
December 1 2002
End Date
September 1 2003
Last Update
March 6 2015
Active Locations (7)
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1
Hangzhou, Zhejiang, China, 310003
2
Beijing, China, 100034
3
Beijing, China, 100044
4
Beijing, China, 100083