Sildenafil Efficacy Study on Time Walk From Peripheral Arterial Desease Patients (Stade II) With Arterial Claudication

Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on treadmill of PAD patients with claudication

Completed

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Key information

Conditions

Peripheral Arterial Occlusive Disease Peripheral Arterial Occlusive Disease 1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil 100mg single oral dose

Drug

Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)

Other names: Viagra verventi

Placebo, Oral intake single dose

Drug

Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)

Other names: Sugar pills manufactured to mimick Sildenafil 100 mg

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study 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

Acronym: ARTERIOFIL

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jul 14, 2016
Registry last updated: Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed