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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This study has been withdrawn prior to enrollment.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:
Information provided by:
The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT00937144
First received: September 24, 2008
Last updated: February 28, 2010
Last verified: July 2009
History of Changes
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937144

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

No publications provided

Responsible Party: baruch padeh poria medical center, ministry of health, Israel
ClinicalTrials.gov Identifier: NCT00937144     History of Changes
Other Study ID Numbers: SCA123-CTIL
Study First Received: September 24, 2008
Last Updated: February 28, 2010
Health Authority: Israel: Ministry of Health

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
 Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013