Peripheral Arterial Occlusive DiseasePhase 3ARTERIOFILNCT02832570
Sildenafil Efficacy Study on Time Walk From Peripheral Arterial Desease Patients (Stade II) With Arterial Claudication
A Phase 3 study testing Sildenafil 100mg single oral dose in people with Peripheral Arterial Occlusive Disease, run by University Hospital, Angers.
Trial summary
Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on treadmill of PAD patients with claudication 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 100mg single oral dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 7 Nov 2016to Oct 2017
- 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
- Patient with peripheral arterial desease stade II
- Patient with vascular claudication for at least 3 months
- Patient able to perform a treadmill walking test with time to walk < 5min
Who cannot join
- Patient suffering from ischemia
- Previous angina or myocardial
- Patient treated with nitrates drugs
- Patient with severe renal insufficiency
- Patient with severe hepatic insufficiency
- Patient with hypotension
About this study
Official title: Etude préliminaire Sur l'efficacité Aigue du Sildenafil Sur le Temps de Marche Chez Les Patients Atteints d'AOMI de Stade II présentant Une Claudication artérielle
Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on treadmill of PAD patients with claudication
Read the detailed description
Sildenafil 100mg or Placebo Oral intake 2 hours before the treadmill test Safety and security control throughout the period of drug efficacy (approx 4 hours) Evaluation of maximal walking distance for a constant load treadmill test (3.2 kml/h 10% slope)
- Conditions
- Peripheral Arterial Occlusive Disease
- Being tested
- Sildenafil 100mg single oral dose, Placebo, Oral intake single 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 100mg single oral doseDrug
Also called Viagra verventi
Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)
Placebo, Oral intake single doseDrug
Also called Sugar pills manufactured to mimick Sildenafil 100 mg
Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | Single sildenafil oral intake (100 mg) approximately 2 hours before the treadmill test. Receives: Drug: Sildenafil 100mg single oral dose |
| Placebo | Placebo comparator | Single placebo intake approximately 2 hours before the treadmill test. Receives: Drug: Placebo, Oral intake single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking duration on treadmill
Treadmill test with consttant load procedure 3.2 km/h H 10% slope up to 15 minutes followed by incremental load according tpo the Bruce protocole thereafter.
Measured: 2 hours after treatment intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start7 Nov 2016
- Primary completionOct 2017
- Study completionOct 2017
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Loukman OMARJEE, MD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832570
- Sponsor's protocol ID
- AOI 2015-07
- Acronym
- ARTERIOFIL
- Status last verified
- Oct 2017
- First submitted
- 12 Jul 2016
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Omarjee L, Le Pabic E, Custaud MA, Fontaine C, Locher C, Renault A, Jaquinandi V, Azzola V, Barbeau-Terrier C, Laporte I, Ripoche M, Onillon Y, Chretien JM, Daniel V, Chao de la Barca JM, Homedan C, Reynier P, Abraham P, Mahe G. Effects of sildenafil on maximum walking time in patients with arterial claudication: The ARTERIOFIL study. Vascul Pharmacol. 2019 Jul-Aug;118-119:106563. doi: 10.1016/j.vph.2019.05.003. Epub 2019 May 30.
PubMed 31152977
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude préliminaire Sur l'efficacité Aigue du Sildenafil Sur le Temps de Marche Chez Les Patients Atteints d'AOMI de Stade II présentant Une Claudication artérielle
- ClinicalTrials.gov ID
- NCT02832570
- Acronym / sponsor ID
- ARTERIOFIL / AOI 2015-07
- Conditions
- Peripheral Arterial Occlusive Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 14 Jul 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.
Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on treadmill of PAD patients with claudication
Detailed description
Sildenafil 100mg or Placebo Oral intake 2 hours before the treadmill test Safety and security control throughout the period of drug efficacy (approx 4 hours) Evaluation of maximal walking distance for a constant load treadmill test (3.2 kml/h 10% slope)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: Sildenafil 100mg single oral doseSingle sildenafil oral intake (100 mg) approximately 2 hours before the treadmill test. |
| Placebo | Placebo comparator | Drug: Placebo, Oral intake single doseSingle placebo intake approximately 2 hours before the treadmill test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with peripheral arterial desease stade II
- Patient with vascular claudication for at least 3 months
- Patient able to perform a treadmill walking test with time to walk < 5min
Key exclusion criteria (6 listed)
- Patient suffering from ischemia
- Previous angina or myocardial
- Patient treated with nitrates drugs
- Patient with severe renal insufficiency
- Patient with severe hepatic insufficiency
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 100mg single oral doseAlso: Viagra verventiMeasurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope) | Drug | Sildenafil |
| Placebo, Oral intake single doseAlso: Sugar pills manufactured to mimick Sildenafil 100 mgMeasurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope) | Drug | Placebo |
Primary outcome
Walking duration on treadmill
Time frame: 2 hours after treatment intake
Treadmill test with consttant load procedure 3.2 km/h H 10% slope up to 15 minutes followed by incremental load according tpo the Bruce protocole thereafter.
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 29 Jul 2022.
- Derived from this study: PubMed 31152977Omarjee L, Le Pabic E, Custaud MA, Fontaine C, Locher C, Renault A, Jaquinandi V, Azzola V, Barbeau-Terrier C, Laporte I, Ripoche M, Onillon Y, Chretien JM, Daniel V, Chao de la Barca JM, Homedan C, Reynier P, Abraham P, Mahe G. Effects of sildenafil on maximum walking time in patients with arterial claudication: The ARTERIOFIL study. Vascul Pharmacol. 2019 Jul-Aug;118-119:106563. doi: 10.1016/j.vph.2019.05.003. Epub 2019 May 30.
- Individual participant dataSharing planned: No
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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 principal investigator
University Hospital, Angers
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil 100mg single oral 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 3 inclusion and 6 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 29 Jul 2022. 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 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?
Walking duration on treadmill (time frame: 2 hours after treatment intake). 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 NCT02832570, 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 29 Jul 2022.