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

This study has been completed.

First Received: April 24, 2008 Last Updated: June 16, 2009 History of Changes

Sponsor:	Bayer
Collaborator:	GlaxoSmithKline
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00668005

Purpose

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

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction High Blood Pressure

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Sexual Encounter Profile (SEP), questions 2 and 3 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

International Index of Erectile Function (IIEF) - EF (Erectile Function) domain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Global Assessment Questionnaire (GAQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	430
Study Start Date:	February 2003
Study Completion Date:	September 2003

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668005

Sponsors and Collaborators

Bayer

GlaxoSmithKline

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare AG ( Therapeutic Area Head )
Study ID Numbers:	100539
Study First Received:	April 24, 2008
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00668005 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Erectile Dysfunction
Arterial hypertension
Vardenafil

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Pharmacologic Actions

Sexual Dysfunction, Physiological
Vardenafil
Phosphodiesterase Inhibitors
Mental Disorders
Cardiovascular Diseases
Erectile Dysfunction
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010