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

NCT02832570 | Completed Phase 3

• 1 other identifier: AOI 2015-07
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sildenafil

EXPERIMENTAL

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

Drug: Sildenafil 100mg single oral dose

Placebo

PLACEBO COMPARATOR

Single placebo intake approximately 2 hours before the treadmill test.

Drug: Placebo, Oral intake single dose

Interventions

Sildenafil 100mg single oral dose DRUG

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

Also known as: Viagra verventi

Sildenafil

Placebo, Oral intake single dose DRUG

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

Also known as: Sugar pills manufactured to mimick Sildenafil 100 mg

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Related Publications (1)

• Omarjee L, Le Pabic E, Custaud MA, Fontaine C, Locher C, Renault A, Jaquinandi V, Azzola V, Barbeau-Terrier C, Laporte I, Ripoche M, Onillon Y, Chretien JM, Daniel V, Chao de la Barca JM, Homedan C, Reynier P, Abraham P, Mahe G. Effects of sildenafil on maximum walking time in patients with arterial claudication: The ARTERIOFIL study. Vascul Pharmacol. 2019 Jul-Aug;118-119:106563. doi: 10.1016/j.vph.2019.05.003. Epub 2019 May 30.

  PMID: 31152977 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Loukman OMARJEE, MD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: November 7, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 29, 2022

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share