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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Sildenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014