Status:
COMPLETED
BAY38-9456 - Pivotal Trial for Diabetes Patient
Lead Sponsor:
Bayer
Conditions:
Erectile Dysfunction
Diabetes Mellitus
Eligibility:
MALE
20-64 years
Phase:
PHASE3
Brief 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 diffe...
Eligibility Criteria
Inclusion
- Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
- Diabetes for more than 3 years
Exclusion
- Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
- Spinal cord injury
- History of surgical prostatectomy (excluding TURP)
- Patients with an HbA1c \> 12% at Visit 1
- Use of nitrates
- Use of potent CYP3a4 inhibitors
- Severe liver disease
- Presence of Peyronie's Disease
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
790 Patients enrolled
Trial Details
Trial ID
NCT00678704
Start Date
January 1 2004
End Date
November 1 2004
Last Update
December 19 2014
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