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

University Hospital, Angers

Status and phase: Completed; Phase 3

Conditions: Peripheral Arterial Occlusive Disease

Treatments: Drug: Sildenafil 100mg single oral dose; Drug: Placebo, Oral intake single dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02832570

AOI 2015-07

Details and patient eligibility

About

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

Full 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)

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

Sildenafil

Experimental group

Description:

Single sildenafil oral intake (100 mg) approximately 2 hours before the treadmill test.

Treatment:

Drug: Sildenafil 100mg single oral dose

Placebo

Placebo Comparator group

Description:

Single placebo intake approximately 2 hours before the treadmill test.

Treatment:

Drug: Placebo, Oral intake single dose