Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and Hypertension
Phase 3
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00668005
- Lead Sponsor
- Bayer
- Brief Summary
Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 388
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Placebo - Arm 1 Levitra (Vardenafil, BAY38-9456) -
- Primary Outcome Measures
Name Time Method Sexual Encounter Profile (SEP), questions 2 and 3 12 weeks
- Secondary Outcome Measures
Name Time Method Global Assessment Questionnaire (GAQ) 12 weeks Safety and tolerability 12 weeks International Index of Erectile Function (IIEF) - EF (Erectile Function) domain 12 weeks