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Effect of Chronic PDE5-Inhibition on Endothelial Function in Diabetics
This study has been completed.
First Received: January 9, 2007   No Changes Posted
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

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

Resource links provided by NLM:


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

No publications provided

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

Keywords provided by IRCCS San Raffaele:
function
inhibition

Study placed in the following topic categories:
Vasodilator Agents
Phosphodiesterase Inhibitors
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Sildenafil
Cardiovascular Agents
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Vasodilator Agents
Phosphodiesterase Inhibitors
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Sildenafil
Cardiovascular Agents
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 09, 2009