Back to resultsSildenafil Efficacy Study on Time Walk From Peripheral Arterial Desease Patients (Stade II) With Arterial Claudication (ARTERIOFIL)
Primary Purpose
Peripheral Arterial Occlusive Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sildenafil 100mg single oral dose
Placebo, Oral intake single dose
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Occlusive Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sildenafil
Placebo
Arm Description
Single sildenafil oral intake (100 mg) approximately 2 hours before the treadmill test.
Single placebo intake approximately 2 hours before the treadmill test.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02832570
First Posted
July 12, 2016
Last Updated
July 28, 2022
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT02832570
Brief Title
Sildenafil Efficacy Study on Time Walk From Peripheral Arterial Desease Patients (Stade II) With Arterial Claudication
Acronym
ARTERIOFIL
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 7, 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil
Arm Type
Experimental
Arm Description
Single sildenafil oral intake (100 mg) approximately 2 hours before the treadmill test.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single placebo intake approximately 2 hours before the treadmill test.
Intervention Type
Drug
Intervention Name(s)
Sildenafil 100mg single oral dose
Other Intervention Name(s)
Viagra verventi
Intervention Description
Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)
Intervention Type
Drug
Intervention Name(s)
Placebo, Oral intake single dose
Other Intervention Name(s)
Sugar pills manufactured to mimick Sildenafil 100 mg
Intervention Description
Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)
Primary Outcome Measure Information:
Title
Walking duration on treadmill
Description
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.
Time Frame
2 hours after treatment intake
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loukman OMARJEE, MD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31152977
Citation
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.
Results Reference
derived
Learn more about this trial
Sildenafil Efficacy Study on Time Walk From Peripheral Arterial Desease Patients (Stade II) With Arterial Claudication
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