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Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis

NCT01347008 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2016-12-05

Study results available
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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.

Conditions

  • Scleroderma, Systemic
  • Scleroderma, Diffuse
  • Scleroderma, Limited
  • Raynaud Phenomenon

Interventions

DRUG

Sildenafil citrate

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

DRUG

Placebo (Sugar pill)

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

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Fernando V Andrigueti, MD · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01347008 on ClinicalTrials.gov