Sickle Cell AnemiaPhase 4NCT00937144
Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil
A Phase 4 study testing Viagra (Sildenafil) in people with Sickle Cell Anemia, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sickle Cell Anemia
- What is being tested?
- Viagra (Sildenafil)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Feb 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with sickle cell anemia
Who cannot join
- patients with sickle cell anemia during acute crisis
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Viagra (Sildenafil), placebo
- Keywords
- endothelial function, endothelial progenitor stem cells
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viagra (Sildenafil)Drug
Viagra treatment to patients with sickle cell anemia.
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| viagra | Experimental | viagra versus placebo will be given to patients with sickle cell anemia Receives: Drug: Viagra (Sildenafil) |
| placebo | Placebo comparator | viagra versus placebo will be given to patients with sickle cell anemia Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function before and after viagra treatment to patients with sickle cell anemia without pulmonary hypertension
Measured: January 2009 till January 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2009 (estimated)
- Study completionFeb 2010 (estimated)
Why it stopped: we didnt recieved the medicine
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937144
- Sponsor's protocol ID
- SCA123-CTIL
- Status last verified
- Jul 2009
- First submitted
- 24 Sep 2008
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil
- ClinicalTrials.gov ID
- NCT00937144
- Acronym / sponsor ID
- SCA123-CTIL
- Conditions
- Sickle Cell Anemia
- Keywords
- endothelial function, endothelial progenitor stem cells
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: we didnt recieved the medicine
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Sep 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| viagra | Experimental | Drug: Viagra (Sildenafil)viagra versus placebo will be given to patients with sickle cell anemia |
| placebo | Placebo comparator | Drug: placeboviagra versus placebo will be given to patients with sickle cell anemia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with sickle cell anemia
Key exclusion criteria (1 listed)
- patients with sickle cell anemia during acute crisis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viagra (Sildenafil)Viagra treatment to patients with sickle cell anemia. | Drug | viagra |
| placebo | Drug | placebo |
Primary outcome
endothelial function before and after viagra treatment to patients with sickle cell anemia without pulmonary hypertension
Time frame: January 2009 till January 2011
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Viagra (Sildenafil) in people with Sickle Cell Anemia, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial function before and after viagra treatment to patients with sickle cell anemia without pulmonary hypertension (time frame: January 2009 till January 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010; AzTrials last refreshed its copy on 31 Oct 2026.