Status:
COMPLETED
Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia
Lead Sponsor:
Bayer
Conditions:
Erectile Dysfunction
Eligibility:
MALE
20-65 years
Phase:
PHASE4
Brief Summary
To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)
Eligibility Criteria
Inclusion
- Age: 20 years and older- Males with erectile dysfunction
- Stable heterosexual relationship
Exclusion
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use
- Other exclusion criteria apply according to the Summary of Product Characteristics
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT00668135
Start Date
March 1 2003
End Date
April 1 2004
Last Update
December 17 2014
Active Locations (13)
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1
Hong Kong, Hong Kong
2
Jakarta, Jakarta Special Capital Region, Indonesia, 10430
3
Petlaing Jaya, Salangor, Malaysia, 47500
4
Kuching, Sarawak, Malaysia