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

Peripheral Arterial Occlusive Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832570
• Other study ID #: AOI 2015-07
• Status: Completed
• Phase: Phase 3
• Start date: November 7, 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Occlusive Disease

Intervention

Drug:
• Sildenafil 100mg single oral dose
Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)
• Placebo, Oral intake single dose
Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 hours after treatment intake