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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 October 2017
Main ID:  NCT01347008
Date of registration: 02/05/2011
Prospective Registration: Yes
Primary sponsor: Federal University of São Paulo
Public title: Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
Scientific title: 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
Date of first enrolment: April 2011
Target sample size: 41
Recruitment status: Completed
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Name:     Fernando V Andrigueti, MD
Affiliation:  Federal University of Sao Paulo
Key inclusion & exclusion criteria

Inclusion Criteria:

- Systemic sclerosis according to the classification criteria of the American College of
Rheumatology (1980) with no more than 4 years since diagnosis

- Early systemic sclerosis as defined by LeRoy and Medsger (2001)

- 6 or more Raynaud's crisis per week

- Written informed consent provided by the subjects prior to initiating study procedures

Exclusion Criteria:

- Smoking

- Peripheral or central vasculopathy other than Systemic sclerosis

- Uncontrolled Diabetes

- Liver disease

- Pregnant or lactating woman

- Current use of cyclosporin, prostanoids, bosentan or any PDE-5 inhibitors (including
current Sildenafil use during randomization)

- History of stroke, myocardial infarction or life threatening cardiac condition within
the last 6 months

- History of surgical sympathectomy

- Systolic blood pressure < 85mm Hg

- History of scleroderma renal crisis

- Known hypersensitivity to Sildenafil or any of the excipients

- History of Retinitis Pigmentosa

- Current use of Nitrates

Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Raynaud Phenomenon
Scleroderma, Diffuse
Scleroderma, Limited
Scleroderma, Systemic
Drug: Placebo (Sugar pill)
Drug: Sildenafil citrate
Primary Outcome(s)
Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus. [Time Frame: 8 weeks]
Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus [Time Frame: 8 weeks]
Secondary Outcome(s)
Daily Frequency of Raynaud's Phenomenon Attacks [Time Frame: 8 weeks]
Secondary ID(s)
FAPESP 2011/00012-3
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Fundação de Amparo à Pesquisa do Estado de São Paulo
Ethics review
Results available: Yes
Date Posted: 05/12/2016
Date Completed:
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