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Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier:
NCT01084187
First received: March 9, 2010
Last updated: April 15, 2011
Last verified: April 2011
History of Changes

March 9, 2010
April 15, 2011
January 2010
December 2010   (final data collection date for primary outcome measure)
clinical response to vardenafil [ Time Frame: four weeks ] [ Designated as safety issue: No ]
SEP 2; SEP 3 and IIEF variation
Same as current
Complete list of historical versions of study NCT01084187 on ClinicalTrials.gov Archive Site
endothelial dysfunction [ Time Frame: four weeks ] [ Designated as safety issue: No ]
variation of FMD of brachial artery from baseline
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Erectile Dysfunction
  • Arterial Hypertension
  • Endothelial Dysfunction
Drug: Vardenafil
vardenafil 20 mg on demand or vardenafil daily or placebo
Other Name: Levitra
  • Active Comparator: vardenafil on demand
    four sexual attempts with 20 mg vardenafil during next four weeks
    Intervention: Drug: Vardenafil
  • Placebo Comparator: placebo
    placebo of vardenafil during four weeks
    Intervention: Drug: Vardenafil
  • Active Comparator: daily vardenafil
    10 mg of vardenafil each day during four weeks
    Intervention: Drug: Vardenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 2011
December 2010   (final data collection date for primary outcome measure)

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
Male
50 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01084187
EDAH2010
No
Valter Javaroni, Hospital Universitário Pedro Ernesto
Hospital Universitario Pedro Ernesto
Not Provided
Study Chair: Mario F Neves, MD, PhD. Hospital Universitário 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
Hospital Universitario Pedro Ernesto
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP