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

Phase 3

Completed

• Conditions: Peripheral Arterial Occlusive Disease
• Interventions: Drug: Placebo, Oral intake single dose; Drug: Sildenafil 100mg single oral dose

• Registration Number: NCT02832570
• Lead Sponsor: University Hospital, Angers

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)

Study Timeline

• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-14
• Study Start: 2016-11-07
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo, Oral intake single dose	Single placebo intake approximately 2 hours before the treadmill test.
Sildenafil	Sildenafil 100mg single oral dose	Single sildenafil oral intake (100 mg) approximately 2 hours before the treadmill test.

Primary Outcome Measures

Name	Time	Method
Walking duration on treadmill	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.