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