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

July 28, 2022 updated by: University Hospital, Angers

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sildenafil
Single sildenafil oral intake (100 mg) approximately 2 hours before the treadmill test.
Drug: Sildenafil 100mg single oral dose
Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)
Other Names:
  • Viagra verventi
Placebo Comparator: Placebo
Single placebo intake approximately 2 hours before the treadmill test.
Drug: Placebo, Oral intake single dose
Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)
Other Names:
  • Sugar pills manufactured to mimick Sildenafil 100 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking duration on treadmill
Time Frame: 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.
2 hours after treatment intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Loukman OMARJEE, MD, University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI 2015-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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