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

NCT00937144 | Withdrawn Phase 4 DMC

• 1 other identifier: SCA123-CTIL
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Sickle Cell Anemia

Keywords

endothelial function; endothelial progenitor stem cells

Outcome Measures

Primary Outcomes (1)

• endothelial function before and after viagra treatment to patients with sickle cell anemia without pulmonary hypertension

  January 2009 till January 2011

Study Arms (2)

viagra

EXPERIMENTAL

viagra versus placebo will be given to patients with sickle cell anemia

Drug: Viagra (Sildenafil)

placebo

PLACEBO COMPARATOR

viagra versus placebo will be given to patients with sickle cell anemia

Drug: placebo

Interventions

Viagra (Sildenafil) DRUG

Viagra treatment to patients with sickle cell anemia.

viagra

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with sickle cell anemia

You may not qualify if:

• patients with sickle cell anemia during acute crisis

Sponsors & Collaborators

• The Baruch Padeh Medical Center, Poriya: lead

Study Sites (1)

Baruch Padeh Poria Medical Center

Tiberias, Lower Galilee, 15208, Israel

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: July 10, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2010
• Last Updated: March 2, 2010

Record last verified: 2009-07

Locations

IL (1)