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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00668005

Collaborator

GlaxoSmithKline (Industry)

388

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

388 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2003

Actual Study Completion Date :

Sep 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) 5mg, 10mg or 20mg taken 1h before sexual intercourse
Placebo Comparator: Arm 2	Drug: Placebo Matching placebo

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Levitra (Vardenafil, BAY38-9456)

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

Placebo Comparator: Arm 2

Drug: Placebo

Matching placebo

Outcome Measures

Primary Outcome Measures

Sexual Encounter Profile (SEP), questions 2 and 3 [12 weeks]

Secondary Outcome Measures

International Index of Erectile Function (IIEF) - EF (Erectile Function) domain [12 weeks]
Global Assessment Questionnaire (GAQ) [12 weeks]
Safety and tolerability [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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