Peripheral Arterial Occlusive DiseasePhase 3VALSTARNCT02930811
Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication
A Phase 3 study testing Sildenafil 100 mg oral morning dose in people with Peripheral Arterial Occlusive Disease, run by University Hospital, Angers.
Trial summary
Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million people around the world and about 7 million people in France. Morbi-mortality from cardiovascular events is increased in this population. Intermittent claudication is the most common clinical feature of PAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- What is being tested?
- Sildenafil 100 mg oral morning dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Oct 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade I cat 2 or 3 claudication despite optimal medical treatment
- Reporting a vascular claudication history for at least 3 months
- Able to achieve a walking treadmill test, Walking time on treadmill (3.2km/h, 10% slope) less than 5 minutes
- Having no cons Sildenafil indication
- Must be on optimal medical therapy (ACE Inhibitors / AT2 Antagonist + Antiplatelet + Lipid Lowering drugs) for at least 1 month
Who cannot join
- Critical ischemia
- Previous history of myocardial infarction or angina not stabilized
- Amblyopia
- Treated with nitrates (nitroglycerin ...) or drugs interfering with the action of the Sildenafil
- Pregnant woman and woman in labor
- Major Person subject to reinforced protection, deprived of their liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than research
- Being in an exclusion period for another biomedical study
About this study
Official title: Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication. A National, Multicentre, Prospective, Randomised, Double-Blind, Placebo-Controlled Trial.
Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million people around the world and about 7 million people in France. Morbi-mortality from cardiovascular events is increased in this population. Intermittent claudication is the most common clinical feature of PAD.
Primary therapeutic approach is medical treatment and advice to walk. Sildenafil, a PDEi type 5, is well tolerated, largely used in impotence and has interesting clinical delay and duration of action in the concept of a potential use in claudication.
For patients agreeing and signing informed consent, randomisation of treatment (placebo/sildenafil) will be done. Treatment will be proposed in addition to usual treatment. The experimental drug will be delivered for a 1 month treatment. First follow up visit at month one will focus on tolerance, compliance and eventual side effects. If no major side effect is found the study drug will then be delivered for an additional 2 months. Patients will be evaluated at month 3 (second follow-up visit) for persistent or non-persistent indication for revascularisation and addressed for revascularization if needed. In parallel focus on tolerance, compliance and eventual side effects will be done. If no major side effect is found, the study drug will be delivered for an additional 3 months treatment. Third and fourth follow-up visit are scheduled at month 6 (end of treatment) and month 9 (3 months after the end of experimental drugs).
- Conditions
- Peripheral Arterial Occlusive Disease
- Being tested
- Sildenafil 100 mg oral morning dose, Placebo oral morning dose
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 100 mg oral morning doseDrug
Also called Experimental: Sildenafil
Measurement of maximal walking distance on a constant load treadmill test, SF-36 questionnaire, and Edimburg questionnaire at inclusion, 1 month, 3 month and 6 month.
Events occurence questionnaires, Tolerance and adverse events questionnaire, Welch questionnaire and walk recommendation at inclusion, 7 days, 14 days, 1-2-3-4-5-6 and 9 months
Placebo oral morning doseDrug
Also called Placebo Comparator: Placebo
Measurement of maximal walking distance on a constant load treadmill test, SF-36 questionnaire, and Edimburg questionnaire at inclusion, 1 month, 3 month and 6 month.
Events occurence questionnaires, Tolerance and adverse events questionnaire, Welch questionnaire and walk recommendation at inclusion, 7 days, 14 days, 1-2-3-4-5-6 and 9 months
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | Single Sildenafil oral morning intake (100mg/day) per day for a total duration of 6 months (Sildenafil 100 mg oral morning dose) Receives: Drug: Sildenafil 100 mg oral morning dose |
| Placebo | Placebo comparator | Single Placebo oral morning intake per day for a total duration of 6 months (Placebo oral morning dose) Receives: Drug: Placebo oral morning dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Event free survival rate
Event free survival is defined as the time between inclusion date and the date of event occurrence. If no event is observed at the follow-up period, event free survival is defined as the delay of follow-up
Measured: 6 months after the treatment begining
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Primary completionOct 2022 (estimated)
Why it stopped: The Investigator-Coordinator has moved to Rennes University Hospital. It will be done under the sponsor of Rennes University Hospital : NCT03686306
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial Occlusive 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Loukman OMARJEE, MD, Study director, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930811
- Sponsor's protocol ID
- PHRC-N-2015
- Acronym
- VALSTAR
- Status last verified
- Nov 2018
- First submitted
- 10 Oct 2016
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Omarjee L, Camarzana A, Henni S, Abraham P. Nonrevascularizable buttock claudication improved with Sildenafil: A case report. Medicine (Baltimore). 2017 Feb;96(8):e6186. doi: 10.1097/MD.0000000000006186.
PubMed 28225505
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication. A National, Multicentre, Prospective, Randomised, Double-Blind, Placebo-Controlled Trial.
- ClinicalTrials.gov ID
- NCT02930811
- Acronym / sponsor ID
- VALSTAR / PHRC-N-2015
- Conditions
- Peripheral Arterial Occlusive Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Investigator-Coordinator has moved to Rennes University Hospital. It will be done under the sponsor of Rennes University Hospital : NCT03686306
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Primary completion
- Oct 2022 (estimated)
- First posted
- 12 Oct 2016 (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.
Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million people around the world and about 7 million people in France. Morbi-mortality from cardiovascular events is increased in this population. Intermittent claudication is the most common clinical feature of PAD.
Primary therapeutic approach is medical treatment and advice to walk. Sildenafil, a PDEi type 5, is well tolerated, largely used in impotence and has interesting clinical delay and duration of action in the concept of a potential use in claudication.
For patients agreeing and signing informed consent, randomisation of treatment (placebo/sildenafil) will be done. Treatment will be proposed in addition to usual treatment. The experimental drug will be delivered for a 1 month treatment. First follow up visit at month one will focus on tolerance, compliance and eventual side effects. If no major side effect is found the study drug will then be delivered for an additional 2 months. Patients will be evaluated at month 3 (second follow-up visit) for persistent or non-persistent indication for revascularisation and addressed for revascularization if needed. In parallel focus on tolerance, compliance and eventual side effects will be done. If no major side effect is found, the study drug will be delivered for an additional 3 months treatment. Third and fourth follow-up visit are scheduled at month 6 (end of treatment) and month 9 (3 months after the end of experimental drugs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: Sildenafil 100 mg oral morning doseSingle Sildenafil oral morning intake (100mg/day) per day for a total duration of 6 months (Sildenafil 100 mg oral morning dose) |
| Placebo | Placebo comparator | Drug: Placebo oral morning doseSingle Placebo oral morning intake per day for a total duration of 6 months (Placebo oral morning dose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Grade I cat 2 or 3 claudication despite optimal medical treatment
- Reporting a vascular claudication history for at least 3 months
- Able to achieve a walking treadmill test, Walking time on treadmill (3.2km/h, 10% slope) less than 5 minutes
- Having no cons Sildenafil indication
- Must be on optimal medical therapy (ACE Inhibitors / AT2 Antagonist + Antiplatelet + Lipid Lowering drugs) for at least 1 month
Key exclusion criteria (7 listed)
- Critical ischemia
- Previous history of myocardial infarction or angina not stabilized
- Amblyopia
- Treated with nitrates (nitroglycerin ...) or drugs interfering with the action of the Sildenafil
- Pregnant woman and woman in labor
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 100 mg oral morning doseAlso: Experimental: SildenafilMeasurement of maximal walking distance on a constant load treadmill test, SF-36 questionnaire, and Edimburg questionnaire at inclusion, 1 month, 3 month and 6 month. Events occurence questionnaires, Tolerance and adverse events questionnaire, Welch questionnaire and walk recommendation at inclusion, 7 days, 14 days, 1-2-3-4-5-6 and 9 months | Drug | Sildenafil |
| Placebo oral morning doseAlso: Placebo Comparator: PlaceboMeasurement of maximal walking distance on a constant load treadmill test, SF-36 questionnaire, and Edimburg questionnaire at inclusion, 1 month, 3 month and 6 month. Events occurence questionnaires, Tolerance and adverse events questionnaire, Welch questionnaire and walk recommendation at inclusion, 7 days, 14 days, 1-2-3-4-5-6 and 9 months | Drug | Placebo |
Primary outcome
Improvement of Event free survival rate
Time frame: 6 months after the treatment begining
Event free survival is defined as the time between inclusion date and the date of event occurrence. If no event is observed at the follow-up period, event free survival is defined as the delay of follow-up
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 6 Nov 2018.
- Derived from this study: PubMed 28225505Omarjee L, Camarzana A, Henni S, Abraham P. Nonrevascularizable buttock claudication improved with Sildenafil: A case report. Medicine (Baltimore). 2017 Feb;96(8):e6186. doi: 10.1097/MD.0000000000006186.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Occlusive Disease
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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.
Loukman OMARJEE, MD study director
University Hospital, Angers
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil 100 mg oral morning dose in people with Peripheral Arterial Occlusive Disease, run by University Hospital, Angers.
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 7 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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 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?
Improvement of Event free survival rate (time frame: 6 months after the treatment begining). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02930811, which also lists 1 linked publication.
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 6 Nov 2018.