Trial Condition(s):
Erectile Dysfunction
Evaluating the efficacy and safety of vardenafil in subjects with erectile dysfunction and hypertension
Bayer Identifier:
100539
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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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