CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
Sildenafil citrate +1 moredrug
Likely dose
Sildenafil citrate 50mgfrom 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/NCT01347008
NCT01347008Phase 3Completed
CompareCT.gov

Effect of Sildenafil on the Microcirculatory Blood Flow and on the Endothelial Progenitor Cells in Patients With Systemic Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial

Federal University of São Paulo·interventional·Posted May 4, 2011·Updated Dec 5, 2016

In Brief

A Phase 3 clinical trial evaluating Sildenafil citrate and Placebo (Sugar pill) for Scleroderma, Systemic and 3 related conditions. Completed, enrolled 41 participants across 1 site.

Detailed Summary

Early phases of systemic sclerosis is characterized by inflammatory and microvasculature alterations. Sildenafil citrate has been shown to have vasodilatory effects and to enhance vasculogenesis. The purpose of this study is to evaluate the effect of sildenafil citrate on hand blood flow of patients with systemic sclerosis, using Laser Doppler Imaging.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScleroderma, Systemic, Scleroderma, Diffuse, Scleroderma, Limited, Raynaud Phenomenon
CountriesBrazil
CollaboratorsFundação de Amparo à Pesquisa do Estado de São Paulo

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2011
Enrollment StartApr 1, 2011
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.2 years ago

Interventions

Sildenafil citratedrug

Oral sildenafil citratre, 50mg b.i.d., 8 weeks

Placebo (Sugar pill)drug

Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks