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

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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

Tracking Information
First Submitted Date  ICMJE July 12, 2016
First Posted Date  ICMJE July 14, 2016
Last Update Posted Date November 1, 2017
Actual Study Start Date  ICMJE November 7, 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2016)
Walking duration [ Time Frame: 2 hours after treatment intake ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sildenafil Efficacy Study on Time Walk From Peripheral Arterial Desease Patients (Stade II) With Arterial Claudication
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Occlusive Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Sildenafil
    Single sildenafil oral intake (100 mg) approximately 2 hours before the treadmill test.
    Intervention: Drug: Sildenafil 100mg single oral dose
  • Placebo Comparator: Placebo
    Single placebo intake approximately 2 hours before the treadmill test.
    Intervention: Drug: Placebo, Oral intake single dose
Publications * 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, Mahé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2016)
14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02832570
Other Study ID Numbers  ICMJE AOI 2015-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Angers
Study Sponsor  ICMJE University Hospital, Angers
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Loukman OMARJEE, MD University Hospital, Angers
PRS Account University Hospital, Angers
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP