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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
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Fernando Villela Andrigueti, Federal University of São Paulo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Limited
Raynaud Phenomenon
Interventions Drug: Sildenafil citrate
Drug: Placebo (Sugar pill)
Enrollment 41
Recruitment Details Patients recruited at the Outpatient Clinic of The Federal University of Sao Paulo, between August 2011 and November 2012
Pre-assignment Details  
Arm/Group Title Sildenafil Citrate Sugar Pill
Hide Arm/Group Description

Oral Sildenafil citrate, 50mg, b.i.d.

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

Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
Period Title: Overall Study
Started 21 20
Completed 21 20
Not Completed 0 0
Arm/Group Title Sildenafil Citrate Sugar Pill Total
Hide Arm/Group Description

Oral Sildenafil citrate, 50mg, b.i.d.

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

Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 21 20 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 20 participants 41 participants
47.2  (10.9) 41.6  (13.3) 44.5  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
Female
21
 100.0%
20
 100.0%
41
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 21 participants 20 participants 41 participants
21 20 41
Digital skin microvascular blood flow measured by Laser Doppler Imaging (LDI) before cold stimulus   [1] 
Mean (Standard Deviation)
Unit of measure:  Perfusion units
Number Analyzed 21 participants 20 participants 41 participants
213.1  (87.9) 241.9  (104.4) 234.6  (105.8)
[1]
Measure Description: 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.   [1] 
Mean (Standard Deviation)
Unit of measure:  Perfusion units
Number Analyzed 21 participants 20 participants 41 participants
178.8  (92.4) 218.6  (98.9) 200.2  (96.1)
[1]
Measure Description: Finger blood flow of the four medial fingers, measured by laser Doppler imaging and expressed in arbitrary perfusion units (p.u.). Measure taken after submersion of both hands in water at 15°C for 1 minute.
Daily frequency of Raynuad's Phenomenon attacks   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of attacks per day
Number Analyzed 21 participants 20 participants 41 participants
2.3  (2.5) 1.9  (2.0) 2.1  (2.3)
[1]
Measure Description: 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.
1.Primary Outcome
Title Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus
Hide Description Finger blood flow of the four medial fingers, measured by laser Doppler imaging and expressed in arbitrary perfusion units (p.u.).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sildenafil Citrate Sugar Pill
Hide Arm/Group Description:

Oral Sildenafil citrate, 50mg, b.i.d.

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

Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
Overall Number of Participants Analyzed 21 20
Mean (Standard Deviation)
Unit of Measure: perfusion units
260.0  (108.0) 246.3  (122.6)
2.Primary Outcome
Title Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus.
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sildenafil Citrate Sugar Pill
Hide Arm/Group Description:

Oral Sildenafil citrate, 50mg, b.i.d.

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

Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
Overall Number of Participants Analyzed 21 20
Mean (Standard Deviation)
Unit of Measure: perfusion units
257.7  (123.3) 220.5  (119.9)
3.Secondary Outcome
Title Daily Frequency of Raynaud's Phenomenon Attacks
Hide Description 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sildenafil Citrate Sugar Pill
Hide Arm/Group Description:

Oral Sildenafil citrate, 50mg, b.i.d.

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

Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
Overall Number of Participants Analyzed 21 20
Mean (Standard Deviation)
Unit of Measure: number of attacks per day
1.9  (2.4) 1.7  (2.2)
Time Frame 10 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sildenafil Citrate Sugar Pill
Hide Arm/Group Description

Oral Sildenafil citrate, 50mg, b.i.d.

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

Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
All-Cause Mortality
Sildenafil Citrate Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sildenafil Citrate Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sildenafil Citrate Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   7/21 (33.33%)   1/20 (5.00%) 
Nervous system disorders     
Headache *  7/21 (33.33%)  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
Small numbers of subjects analyzed; blood flow differences due to outside temperature variations
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Fernando Villela Andrigueti, MD
Organization: Federal University of Sao Paulo
Phone: +55 11 55764239
Responsible Party: Fernando Villela Andrigueti, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01347008     History of Changes
Other Study ID Numbers: FAPESP 2011/00012-3
First Submitted: May 2, 2011
First Posted: May 4, 2011
Results First Submitted: August 20, 2016
Results First Posted: December 5, 2016
Last Update Posted: December 5, 2016