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

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ClinicalTrials.gov Identifier: NCT00937144
Recruitment Status : Withdrawn (we didnt recieved the medicine)
First Posted : July 10, 2009
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
The Baruch Padeh Medical Center, Poriya

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).

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Drug: Viagra (Sildenafil) Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2009
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: viagra
viagra versus placebo will be given to patients with sickle cell anemia
Drug: Viagra (Sildenafil)
Viagra treatment to patients with sickle cell anemia.
Placebo Comparator: placebo
viagra versus placebo will be given to patients with sickle cell anemia
Drug: placebo



Primary Outcome Measures :
  1. endothelial function before and after viagra treatment to patients with sickle cell anemia without pulmonary hypertension [ Time Frame: January 2009 till January 2011 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with sickle cell anemia

Exclusion Criteria:

  • patients with sickle cell anemia during acute crisis

Information from the National Library of Medicine

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): NCT00937144


Locations
Israel
Baruch Padeh Poria Medical Center
Tiberias, Lower Galilee, Israel, 15208
Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya

Responsible Party: baruch padeh poria medical center, ministry of health, Israel
ClinicalTrials.gov Identifier: NCT00937144     History of Changes
Other Study ID Numbers: SCA123-CTIL
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: July 2009

Keywords provided by The Baruch Padeh Medical Center, Poriya:
endothelial function
endothelial progenitor stem cells

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents