Effect of Chronic PDE5-Inhibition on Endothelial Function in Diabetics

Diabetes Clinical Trial

Official title:

Effect of Chronic Administration of Sildenafil on Endothelial Function in Men With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420901
• Other study ID #: HSRRM1999/4
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2007
• Last updated: January 9, 2007
• Start date: January 1999
• Est. completion date: February 2000

Study information

• Verified date: January 2007
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

chronic PDE5-Inhibition improves endothelial function in diabetics

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2000
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• type 2 diabetes

• males

Exclusion Criteria:

• females, nitrate use, PDE5-Inhibitors intolerance

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• sildenafil

Locations

Country	Name	City	State
Italy	San Raffaele EUR	Roma

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function responders - Improvement in endothelial function
Secondary	Changes in vascular inflammatory markers