Back to resultsEndothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil
Primary Purpose
Sickle Cell Anemia
Status
Withdrawn
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Viagra (Sildenafil)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Anemia focused on measuring endothelial function, endothelial progenitor stem cells
Eligibility Criteria
Inclusion Criteria:
- patients with sickle cell anemia
Exclusion Criteria:
- patients with sickle cell anemia during acute crisis
Sites / Locations
- Baruch Padeh Poria Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
viagra
placebo
Arm Description
viagra versus placebo will be given to patients with sickle cell anemia
viagra versus placebo will be given to patients with sickle cell anemia
Outcomes
Primary Outcome Measures
endothelial function before and after viagra treatment to patients with sickle cell anemia without pulmonary hypertension
Secondary Outcome Measures
Full Information
NCT ID
NCT00937144
First Posted
September 24, 2008
Last Updated
February 28, 2010
Sponsor
The Baruch Padeh Medical Center, Poriya
1. Study Identification
Unique Protocol Identification Number
NCT00937144
Brief Title
Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Withdrawn
Why Stopped
we didnt recieved the medicine
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
February 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The Baruch Padeh Medical Center, Poriya
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators would like to study the endothelial function in sickle cell patients without pulmonary hypertension in an in vivo method during a steady state condition before and after sildenafil treatment for 1 month, and to study the effects of this nitric oxide donor by measuring the Flow Mediated Dilatation, by measuring endothelial progenitor stem cells colonies, and by measuring the effect of therapy on markers of inflammation (cell adhesion molecules and cytokines).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Anemia
Keywords
endothelial function, endothelial progenitor stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
viagra
Arm Type
Experimental
Arm Description
viagra versus placebo will be given to patients with sickle cell anemia
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
viagra versus placebo will be given to patients with sickle cell anemia
Intervention Type
Drug
Intervention Name(s)
Viagra (Sildenafil)
Intervention Description
Viagra treatment to patients with sickle cell anemia.
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
endothelial function before and after viagra treatment to patients with sickle cell anemia without pulmonary hypertension
Time Frame
January 2009 till January 2011
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with sickle cell anemia
Exclusion Criteria:
patients with sickle cell anemia during acute crisis
Facility Information:
Facility Name
Baruch Padeh Poria Medical Center
City
Tiberias
State/Province
Lower Galilee
ZIP/Postal Code
15208
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil
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