Official Title: “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”

Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • 5mg, 10mg or 20mg taken 1h before sexual intercourse
• Drug: Placebo
  • Matching placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Placebo Comparator: Arm 2

Primary Measures

• Sexual Encounter Profile (SEP), questions 2 and 3
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• International Index of Erectile Function (IIEF) - EF (Erectile Function) domain
  • Time Frame: 12 weeks
    Safety Issue?: No
• Global Assessment Questionnaire (GAQ)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668005

Study ID Number: 100539

ClinicalTrials.gov Identifier: NCT00668005

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Click here to find results for studies related to marketed products

Click here and search for drug information provided by the FDA

Click here and search for information on any recalls, market or product safety alerts by the FDA