Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction
Correlation of Flow Mediated Dilation of Brachial Artery and Carotid Intima Media Thickness With Erectile Dysfunction Severity and Clinical Response to PDE 5 Inhibitor in Hypertensive Men
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 9, 2010
CompletedFirst Posted
Study publicly available on registry
March 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedApril 18, 2011
April 1, 2011
11 months
March 9, 2010
April 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical response to vardenafil
SEP 2; SEP 3 and IIEF variation
four weeks
Secondary Outcomes (1)
endothelial dysfunction
four weeks
Study Arms (3)
vardenafil on demand
ACTIVE COMPARATORfour sexual attempts with 20 mg vardenafil during next four weeks
placebo
PLACEBO COMPARATORplacebo of vardenafil during four weeks
daily vardenafil
ACTIVE COMPARATOR10 mg of vardenafil each day during four weeks
Interventions
vardenafil 20 mg on demand or vardenafil daily or placebo
Eligibility Criteria
You may qualify if:
- arterial hypertension and erectile dysfunction of vascular origin for at least 6 month
You may not qualify if:
- other condition that cause erectile dysfunction such as depression, hypogonadism, surgery, trauma, major cardiovascular event
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitário Pedro Ernesto
Rio de Janeiro, Rio de Janeiro, 20551030, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mario F Neves, MD, PhD.
Hospital Universitario Pedro Ernesto
- PRINCIPAL INVESTIGATOR
Valter Javaroni, MD, MSc
State University of Rio de Janeiro
- STUDY DIRECTOR
Wille Oigman, MD, PhD
State University of Rio de Janeiro
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 9, 2010
First Posted
March 10, 2010
Study Start
January 1, 2010
Primary Completion
December 1, 2010
Study Completion
February 1, 2011
Last Updated
April 18, 2011
Record last verified: 2011-04