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Effect of Chronic PDE5-Inhibition on Endothelial Function in Diabetics

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ClinicalTrials.gov Identifier: NCT00420901
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : January 11, 2007
Information provided by:
IRCCS San Raffaele

Brief Summary:
chronic PDE5-Inhibition improves endothelial function in diabetics

Condition or disease Intervention/treatment Phase
Diabetes Drug: sildenafil Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Chronic Administration of Sildenafil on Endothelial Function in Men With Diabetes
Study Start Date : January 1999
Estimated Study Completion Date : February 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Endothelial function responders - Improvement in endothelial function

Secondary Outcome Measures :
  1. Changes in vascular inflammatory markers

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • type 2 diabetes
  • males

Exclusion Criteria:

  • females, nitrate use, PDE5-Inhibitors intolerance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420901

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

ClinicalTrials.gov Identifier: NCT00420901     History of Changes
Other Study ID Numbers: HSRRM1999/4
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: January 11, 2007
Last Verified: January 2007

Keywords provided by IRCCS San Raffaele:

Additional relevant MeSH terms:
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents