Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

NCT ID: NCT01084187

Last Updated: 2011-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-02-28

Brief Summary

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The purpose of the study is to assess the correlation of FMD of brachial artery and carotid intima media thickness with ED severity and clinical response to vardenafil in hypertensive men.

Detailed Description

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To achieve this objective, a prospective study will be conducted, with hypertensive patients ranging from 50 to 70 years, presenting vasculogenic erectile dysfunction for over six months and sexually actives. All patients will be assessed for clinical and laboratorial data, endothelial dysfunction, endothelium independent vasodilation and carotid intima media thickness at the inclusion of the study. They will receive medical orientations from the same urologist and will return after four attempts with 20 mg of vardenafil.

Conditions

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Erectile Dysfunction Arterial Hypertension Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vardenafil on demand

four sexual attempts with 20 mg vardenafil during next four weeks

Group Type ACTIVE_COMPARATOR

Vardenafil

Intervention Type DRUG

vardenafil 20 mg on demand or vardenafil daily or placebo

placebo

placebo of vardenafil during four weeks

Group Type PLACEBO_COMPARATOR

Vardenafil

Intervention Type DRUG

vardenafil 20 mg on demand or vardenafil daily or placebo

daily vardenafil

10 mg of vardenafil each day during four weeks

Group Type ACTIVE_COMPARATOR

Vardenafil

Intervention Type DRUG

vardenafil 20 mg on demand or vardenafil daily or placebo

Interventions

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Vardenafil

vardenafil 20 mg on demand or vardenafil daily or placebo

Intervention Type DRUG

Other Intervention Names

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Levitra

Eligibility Criteria

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Inclusion Criteria

* arterial hypertension and erectile dysfunction of vascular origin for at least 6 month

Exclusion Criteria

* other condition that cause erectile dysfunction such as depression, hypogonadism, surgery, trauma, major cardiovascular event
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Pedro Ernesto

OTHER

Sponsor Role lead

Responsible Party

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Hospital Universitário Pedro Ernesto

Principal Investigators

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Mario F Neves, MD, PhD.

Role: STUDY_CHAIR

Hospital Universitario Pedro Ernesto

Valter Javaroni, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

State University of Rio de Janeiro

Wille Oigman, MD, PhD

Role: STUDY_DIRECTOR

State University of Rio de Janeiro

Locations

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Hospital Universitário Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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EDAH2010

Identifier Type: -

Identifier Source: org_study_id

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