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

University Hospital, Angers14 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Peripheral Arterial Occlusive Disease

Interventions

Sildenafil 100mg single oral doseDRUG

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

Placebo, Oral intake single doseDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 2 hours after treatment intake

Data from ClinicalTrials.gov

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