Peripheral Arterial DiseasePhase 2/3NCT02387450
Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
A Phase 2/3 study testing Sildenafil in people with Peripheral Arterial Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Sep 2017
- Phase
- Phase 2/3
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ABI<0.90
- Vascular type claudication
- stable walking impairment for at least 3 months
- Optimal cardiovasc treatment (Anti-platelet, HMGCoA-Inh, ACE-Inh or AT2 inh)
- Age > 30 years
Who cannot join
- Refuse to participate
- Administrative protection
- Severe renal (clearance < 30 ml/min) or hepatic (Child-Pugh C) failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil
Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study.
Read the detailed description
Eligible patients will ask to participate after oral and written information. Evaluation of walking capacity (self reported and treadmill measured), co-morbid condition and quality of life (WELCH, SF-36, Edinburg) will be performed at inclusion, after the first dose and at 3 months of oral treatment through sildenafil 100mg/day or placebo from inclusion to 3 months.
Indication for revascularisation will be evaluated at 3 months according to symptoms and walking capacity according to the Rutherford classification.
Primary endpoint is the proportion of patients showing either a fatal events (cardio-vascular or noncardiovascular) or hospitalisation for non fatal cardiovascular events at 6 and 9 months follow up from inclusion.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Sildenafil, Placebo
- Keywords
- Claudication, Maximal walking distance, Morbi-mortality
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Viagra or revatio
100 mg per day
PlaceboDrug
Placebo with same presentation as the active drug
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Active comparator | Sildenafil, oral, 100mg per day Receives: Drug: Sildenafil |
| Control group | Placebo comparator | placebo oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage)
Measured: 6 months
Secondary outcomes (4)
Quality of life Questionnaire
Measured: 3, 6 and 9 months
Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event)
Proportion of Participants with Adverse Events (sildenafil vs. placebo)
Measured: 3, 6 and 9 months
Walking capacity (treadmill test)
treadmill test
Measured: 3, 6 and 9 months
Proportion of revascularized patients
Revascularisation
Measured: 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- pierre Abraham, MD, PhD, Principal investigator, University Hospital in Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387450
- Sponsor's protocol ID
- Ongoing recording
- Status last verified
- Mar 2015
- First submitted
- 2 Mar 2015
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil
- ClinicalTrials.gov ID
- NCT02387450
- Acronym / sponsor ID
- Ongoing recording
- Conditions
- Peripheral Arterial Disease
- Keywords
- Claudication, Maximal walking distance, Morbi-mortality
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Sep 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 13 Mar 2015 (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.
Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study.
Detailed description
Eligible patients will ask to participate after oral and written information. Evaluation of walking capacity (self reported and treadmill measured), co-morbid condition and quality of life (WELCH, SF-36, Edinburg) will be performed at inclusion, after the first dose and at 3 months of oral treatment through sildenafil 100mg/day or placebo from inclusion to 3 months.
Indication for revascularisation will be evaluated at 3 months according to symptoms and walking capacity according to the Rutherford classification.
Primary endpoint is the proportion of patients showing either a fatal events (cardio-vascular or noncardiovascular) or hospitalisation for non fatal cardiovascular events at 6 and 9 months follow up from inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group | Active comparator | Drug: SildenafilSildenafil, oral, 100mg per day |
| Control group | Placebo comparator | Drug: Placeboplacebo oral |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ABI<0.90
- Vascular type claudication
- stable walking impairment for at least 3 months
- Optimal cardiovasc treatment (Anti-platelet, HMGCoA-Inh, ACE-Inh or AT2 inh)
- Age > 30 years
Key exclusion criteria (3 listed)
- Refuse to participate
- Administrative protection
- Severe renal (clearance < 30 ml/min) or hepatic (Child-Pugh C) failure
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 |
|---|---|---|
| SildenafilAlso: Viagra or revatio100 mg per day | Drug | Treated group |
| PlaceboPlacebo with same presentation as the active drug | Drug | Control group |
Primary outcome
Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage)
Time frame: 6 months
4 secondary outcomes
Quality of life Questionnaire
Time frame: 3, 6 and 9 months
Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event)
Time frame: 3, 6 and 9 months
Walking capacity (treadmill test)
Time frame: 3, 6 and 9 months
Proportion of revascularized patients
Time frame: 6 and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
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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.
pierre Abraham, MD, PhD principal investigator
University Hospital in Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sildenafil in people with Peripheral Arterial Disease, run by University Hospital, Angers at 1 site in France.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Mar 2015. 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 France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact pierre ABRAHAM, MD, PhD (+33 241353689, piabraham@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage) (time frame: 6 months). 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 13 Mar 2015.