CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 59 enrolled
Drug / intervention
Sildenafil +1 moredrug
Likely dose
Sildenafil 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00692237
NCT00692237Phase 4Completed
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Cardiovascular Effects of Chronic Sildenafil (Viagra) Treatment in Diabetic Subjects With Endothelial Dysfunction.

University of Roma La Sapienza·interventional·Posted Jun 6, 2008·Updated May 8, 2013

In Brief

A Phase 4 clinical trial evaluating Sildenafil and Placebo for Diabetes Mellitus, Type 2 and Endothelial Dysfunction. Completed, enrolled 59 participants across 1 site.

Detailed Summary

Type 2 Diabetes Mellitus (T2DM) represents a model of endothelial dysfunction, where chronic nitric oxide deprivation, hyperglycaemia and hyperinsulinemia and fibrogenic mediators lead to cardiovascular remodelling associated with diabetic cardiomyopathy and in consequence to secondary complications of diabetes. Specific anti-oxidative and anti-fibrotic therapies are not currently available. Sildenafil (Viagra) has demonstrated the capability of significantly improving endothelial dysfunction and cardiac fibrosis in experimental animal models. The purpose of the present study is performed to establish the effect of chronic high dose sildenafil treatment on heart performance in diabetic subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Endothelial Dysfunction
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2008
Enrollment StartJan 1, 2008
Primary CompletionSep 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.1 years ago

Interventions

Sildenafildrug

100 mg daily (3 capsules/day)

Placebodrug

Placebo 100 mg (3 capsules/day)