Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and Hypertension

Verified by: Bayer, June 2009
First Received: April 24, 2008 | Last Updated: June 16, 2009 | Phase: Phase 3 | Start Date: February 2003
Overall Status: Completed | Estimated Enrollment: 430
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Assess efficacy of Vardenafil in patients erectile dysfunction and high blood...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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