Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
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|ClinicalTrials.gov Identifier: NCT01347008|
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Limited Raynaud Phenomenon||Drug: Sildenafil citrate Drug: Placebo (Sugar pill)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Active Comparator: Sildenafil citrate
Oral Sildenafil citrate, 50mg, b.i.d.
Drug: Sildenafil citrate
Oral sildenafil citratre, 50mg b.i.d., 8 weeks
Other Name: Sildenafil citrate, EMS Sigma Pharma, Ltd, Brazil
Placebo Comparator: Sugar pill
Placebo pill (identical to Sildenafil citrate 50mg), b.i.d.
Drug: Placebo (Sugar pill)
Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
Other Name: Placebo
- Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus [ Time Frame: 8 weeks ]Finger blood flow of the four medial fingers, measured by laser Doppler imaging and expressed in arbitrary perfusion units (p.u.).
- Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus. [ Time Frame: 8 weeks ]
- Daily Frequency of Raynaud's Phenomenon Attacks [ Time Frame: 8 weeks ]Daily frequency of RP attacks as self registered in a 1-week diary. Any episode of pallor or cyanosis of the hand/fingers was considered as a RP attack, and patients were supposed to register the daily amount of such episodes on a 1-week diary, previously to the medical visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347008
|Systemic Sclerosis Outpatient Clinic, Hospital Sao Paulo, UNIFESP|
|Sao Paulo, SP, Brazil|
|Principal Investigator:||Fernando V Andrigueti, MD||Federal University of Sao Paulo|