Trial Condition(s):
Erectile Dysfunction
Evaluating the efficacy and safety of vardenafil in subjects with erectile dysfunction and hypertension
Study Completed
Trial Purpose
Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure
Inclusion Criteria
- Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, - Arterial hypertension adequately controlled - Stable sexual relationship for > 6 month
Exclusion Criteria
- Primary hypoactive sexual desire - History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month - Nitrate therapy
Trial Summary
Enrollment Goal
388
Trial Dates
Phase
3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No
Where to Participate
Locations
Status
| Locations | Status |
|---|
Trial Design
A randomized, double-blind, parallel-group, plac-controlled study evaluating the efficacy and safety of vardenafil administration for 12 weeks in a flexible-dose regimen compared to placebo in men with arterial hypertension and erectile dysfunction
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Sexual Encounter Profile (SEP), questions 2 and 3Timeframe: 12 weeks
Secondary Outcome
- International Index of Erectile Function (IIEF) - EF (Erectile Function) domainTimeframe: 12 weeks
- Global Assessment Questionnaire (GAQ)Timeframe: 12 weeks
- Safety and tolerabilityTimeframe: 12 weeks
Additional Information
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