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Effect of Chronic PDE5-Inhibition on Endothelial Function in Diabetics

This study has been completed.
Sponsor:
Information provided by:
IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00420901
First received: January 9, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

chronic PDE5-Inhibition improves endothelial function in diabetics


Condition Intervention Phase
Diabetes
 Drug: sildenafil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Chronic Administration of Sildenafil on Endothelial Function in Men With Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

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

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

Keywords provided by IRCCS San Raffaele:
function
inhibition

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sildenafil
Vasodilator Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013