Correlation Study of Vascular Parameters in Hypertensive... | NCT01084187

Studies
Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

NCT01084187

Sponsor

Hospital Universitario Pedro Ernesto

Status

Completed

Last Update Posted

Apr 18, 2011Estimated

Enrollment

100Actual

Phase

Phase 4

Conditions

Erectile Dysfunction
Arterial Hypertension
Endothelial Dysfunction

Interventions

Vardenafil

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Feb 2011Actual

First Submitted Date

Mar 9, 2010

First Submission Date that Met QC Criteria

Mar 9, 2010

First Posted Date

Mar 10, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2011

Last Update Posted Date

Apr 18, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vardenafil on demand	Active Comparator	four sexual attempts with 20 mg vardenafil during next four weeks	Drug: Vardenafil
placebo	Placebo Comparator	placebo of vardenafil during four weeks	Drug: Vardenafil
daily vardenafil	Active Comparator	10 mg of vardenafil each day during four weeks	Drug: Vardenafil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vardenafil	Drug	vardenafil 20 mg on demand or vardenafil daily or placebo	daily vardenafil placebo vardenafil on demand

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical response to vardenafil	SEP 2; SEP 3 and IIEF variation	four weeks

Secondary Outcomes

Measure	Description	Time Frame
endothelial dysfunction	variation of FMD of brachial artery from baseline	four weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mario F Neves, MD, PhD.	Hospital Universitario Pedro Ernesto	Study Chair
Valter Javaroni, MD, MSc	State University of Rio de Janeiro	Principal Investigator
Wille Oigman, MD, PhD	State University of Rio de Janeiro	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitário Pedro Ernesto		Rio de Janeiro	Rio de Janeiro	20551030	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction
D006973	Hypertension

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069058	Vardenafil Dihydrochloride

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided