DiabetesPhase 3NCT00420901
Effect of Chronic PDE5-Inhibition on Endothelial Function in Diabetics
A Phase 3 study testing sildenafil in people with Diabetes, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
chronic PDE5-Inhibition improves endothelial function in diabetics Read more about this study
- Who is it for?
- Ages 35 to 75 years, men only
- Conditions the study is for
- Diabetes
- What is being tested?
- sildenafil
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jan 1999to Feb 2000
- Phase
- Phase 3
- 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 35 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- males
Who cannot join
- females, nitrate use, PDE5-Inhibitors intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Chronic Administration of Sildenafil on Endothelial Function in Men With Diabetes
chronic PDE5-Inhibition improves endothelial function in diabetics
Read the detailed description
Evaluation of endothelial function at baseline and after chronic administration of sildenafil in male subjects with diabetes
- Conditions
- Diabetes
- Being tested
- sildenafil
- Keywords
- function, inhibition
- Medical subject headings
- Diabetes Mellitus, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function responders - Improvement in endothelial function
Secondary outcomes (1)
Changes in vascular inflammatory markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startJan 1999
- Study completionFeb 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- giuseppe rosano, md, Study director, San Raffaele EUR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420901
- Sponsor's protocol ID
- HSRRM1999/4
- Status last verified
- Jan 2007
- First submitted
- 9 Jan 2007
- Last updated
- 11 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chronic Administration of Sildenafil on Endothelial Function in Men With Diabetes
- ClinicalTrials.gov ID
- NCT00420901
- Acronym / sponsor ID
- HSRRM1999/4
- Conditions
- Diabetes
- Keywords
- function, inhibition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jan 1999
- Study completion
- Feb 2000
- First posted
- 11 Jan 2007 (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.
chronic PDE5-Inhibition improves endothelial function in diabetics
Detailed description
Evaluation of endothelial function at baseline and after chronic administration of sildenafil in male subjects with diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetes
- males
Key exclusion criteria (1 listed)
- females, nitrate use, PDE5-Inhibitors intolerance
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 |
|---|---|---|
| sildenafil | Drug | – |
Primary outcome
Endothelial function responders - Improvement in endothelial function
1 secondary outcome
Changes in vascular inflammatory markers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2007.
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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.
giuseppe rosano, md study director
San Raffaele EUR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sildenafil in people with Diabetes, run by IRCCS San Raffaele at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 11 Jan 2007. 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 Italy. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 responders - Improvement in endothelial function. 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 11 Jan 2007.