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Effect of Chronic PDE5-Inhibition on Endothelial Function in Diabetics
This study has been completed.
Sponsored by: IRCCS San Raffaele
Information provided by: IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT00420901
  Purpose

chronic PDE5-Inhibition improves endothelial function in diabetics


Condition Intervention Phase
Diabetes
Drug: sildenafil
Phase III

MedlinePlus related topics: Diabetes
Drug Information available for: Sildenafil citrate Sildenafil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Effect of Chronic Administration of Sildenafil on Endothelial Function in Men With Diabetes

Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • Endothelial function responders - Improvement in endothelial function

Secondary Outcome Measures:
  • Changes in vascular inflammatory markers

Estimated Enrollment: 30
Study Start Date: January 1999
Estimated Study Completion Date: February 2000
Detailed Description:

Evaluation of endothelial function at baseline and after chronic administration of sildenafil in male subjects with diabetes

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes
  • males

Exclusion Criteria:

  • females, nitrate use, PDE5-Inhibitors intolerance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420901

Locations
Italy
San Raffaele EUR
Roma, Italy, 00144
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Study Director: giuseppe rosano, md San Raffaele EUR
  More Information

Study ID Numbers: HSRRM1999/4
Study First Received: January 9, 2007
Last Updated: January 9, 2007
ClinicalTrials.gov Identifier: NCT00420901  
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS San Raffaele:
function
inhibition

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Sildenafil
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009