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

Phase 3CompletedNCT00668005

Bayer388 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

388

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

5mg, 10mg or 20mg taken 1h before sexual intercourse

PlaceboDRUG

Matching placebo

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Sexual Encounter Profile (SEP), questions 2 and 3

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 12 weeks

Global Assessment Questionnaire (GAQ)

Time frame: 12 weeks

Safety and tolerability

Time frame: 12 weeks

Data from ClinicalTrials.gov

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