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NCT00937144 Clinical Trial

Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil

Sickle Cell Anemia Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00937144
Other study ID # SCA123-CTIL
Secondary ID
Status Withdrawn
Phase Phase 4
First received September 24, 2008
Last updated February 28, 2010
Start date September 2009
Est. completion date February 2010

Study information
Verified date July 2009
Source The Baruch Padeh Medical Center, Poriya
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 15
Est. completion date February 2010
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- patients with sickle cell anemia

Exclusion Criteria:

- patients with sickle cell anemia during acute crisis

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Viagra (Sildenafil)
Viagra treatment to patients with sickle cell anemia.
• placebo

Locations
Country Name City State
Israel Baruch Padeh Poria Medical Center Tiberias Lower Galilee

Sponsors (1)
Lead Sponsor Collaborator
The Baruch Padeh Medical Center, Poriya

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary endothelial function before and after viagra treatment to patients with sickle cell anemia without pulmonary hypertension January 2009 till January 2011 No
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