Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil
Sponsors
Source
The Baruch Padeh Medical Center, Poriya
Oversight Info
Has Dmc
Yes
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).
Overall Status
Withdrawn
Start Date
2009-09-01
Completion Date
2010-02-01
Primary Completion Date
2009-09-01
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
endothelial function before and after viagra treatment to patients with sickle cell anemia without pulmonary hypertension |
January 2009 till January 2011 |
Enrollment
15
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Viagra treatment to patients with sickle cell anemia.
Arm Group Label
viagra
Eligibility
Criteria
Inclusion Criteria:
- patients with sickle cell anemia
Exclusion Criteria:
- patients with sickle cell anemia during acute crisis
Gender
All
Minimum Age
18 Years
Maximum Age
60 Years
Healthy Volunteers
No
Location
Facility |
|
Baruch Padeh Poria Medical Center Tiberias Lower Galilee 15208 Israel |
Location Countries
Country
Israel
Verification Date
2009-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Name Title
baruch padeh poria medical center
Organization
ministry of health, Israel
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Sildenafil Citrate
Arm Group
Arm Group Label
viagra
Arm Group Type
Experimental
Description
viagra versus placebo will be given to patients with sickle cell anemia
Arm Group Label
placebo
Arm Group Type
Placebo Comparator
Description
viagra versus placebo will be given to patients with sickle cell anemia
Firstreceived Results Date
N/A
Why Stopped
we didnt recieved the medicine
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Double (Care Provider, Investigator)
Study First Submitted
September 24, 2008
Study First Submitted Qc
July 9, 2009
Study First Posted
July 10, 2009
Last Update Submitted
February 28, 2010
Last Update Submitted Qc
February 28, 2010
Last Update Posted
March 2, 2010
ClinicalTrials.gov processed this data on November 29, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.