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

Condition(s) targeted: Erectile Dysfunction

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

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

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

Primary outcome: Sexual Encounter Profile (SEP), questions 2 and 3

Secondary outcome:

International Index of Erectile Function (IIEF) - EF (Erectile Function) domain

Global Assessment Questionnaire (GAQ)

Safety and tolerability

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

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Starting date: February 2003
Ending date: September 2003
Last updated: April 27, 2008