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

This study has been withdrawn prior to enrollment.
(we didnt recieved the medicine)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00937144
First Posted: July 10, 2009
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Baruch Padeh Medical Center, Poriya
  Purpose
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 Intervention Phase
Sickle Cell Anemia Drug: Viagra (Sildenafil) Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Baruch Padeh Medical Center, Poriya:

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

Estimated Enrollment: 15
Study Start Date: September 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: September 24, 2008
First Posted: July 10, 2009
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