Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02832570
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Occlusive Disease Drug: Sildenafil 100mg single oral dose Drug: Placebo, Oral intake single dose Phase 3

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 7, 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Sugar pills manufactured to mimick Sildenafil 100 mg




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832570


Sponsors and Collaborators
University Hospital, Angers
Investigators
Layout table for investigator information
Principal Investigator: Loukman OMARJEE, MD University Hospital, Angers

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02832570    
Other Study ID Numbers: AOI 2015-07
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents