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VIRTUOSE : Efficiency of Sildenafil on the Absolute Claudication Distance of Peripheral Arterial Disease Patients With Intermittent Claudication.

Study acronym: VIRTUOSE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 24, 2025 (before its estimated November 24, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Nov 24, 2024 to Nov 24, 2025v10 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 220 to confirmed 106
    • Study sites: 13 to 11
    • Study completion date: Jun 24, 2025 to Jun 24, 2026
  2. Primary completion date: Nov 16, 2022 to Nov 24, 2024v9 Show 5 more changesShow less
    • Study sites: 12 to 13
    • Study completion date: Jun 16, 2023 to Jun 24, 2025
    • Start date: Nov 16, 2021 to Nov 24, 2021
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 4 words
  3. Site details revised at 7 of 12 sitesv8
  4. Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Primary completion date: Oct 28, 2022 to Nov 16, 2022
    • Study completion date: May 28, 2023 to Jun 16, 2023
    • Start date changed from estimate of Oct 28, 2021 to Nov 16, 2021
    • Site details revised at 12 of 12 sites
  5. Start date: May 1, 2021 to Oct 28, 2021v6 Show 6 more changesShow less
    • Primary completion date: Aug 1, 2022 to Oct 28, 2022
    • Study completion date: Aug 1, 2023 to May 28, 2023
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: 10 to 15
    • Study sites revised (12)
    • Study description expanded, about 2 words
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Mar 1, 2021 to May 1, 2021v5 Show 6 more changesShow less
    • Study sites: 1 to 12
    • Primary completion date: Jun 1, 2022 to Aug 1, 2022
    • Study completion date: Jun 1, 2023 to Aug 1, 2023
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints: 9 to 10
    • Study description shortened, about 13 words
  2. Start date: Dec 1, 2020 to Mar 1, 2021
    • Primary completion date: Mar 1, 2022 to Jun 1, 2022
    • Study completion date: Mar 1, 2023 to Jun 1, 2023
    v4
  3. Start date: Mar 1, 2020 to Dec 1, 2020v3
  4. Start date: Dec 1, 2018 to Mar 1, 2020
    • Primary completion date: Dec 1, 2021 to Mar 1, 2022
    • Study completion date: Jun 1, 2022 to Mar 1, 2023
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million people around the world and about 7 million people in France. Morbi-mortality from cardiovascular events is increased in this population. Intermittent claudication is defined as a discomfort and/or pain in the legs during walking. It is the most common clinical feature of PAD. In claudication, primary therapeutic approach is medical treatment and advice to walk. Revascularization is only proposed when medical treatment and advice to walk for at least 3 to 6 months have failed to improve symptoms and walking ability. Optimal medical treatment includes Antiplatelet, Lipid Lowering Drugs, AT2 antagonists / ACE Inhibitors and advice to walk. To date, no other drug has provided consistent evidence for functional improvement in claudication, except for Cilostazol, a type-3 phospho-diesterase inhibitor (PDEi). This compound has been scarcely used in France due to cost and frequent side effect (Headache, Flush, Diarrhea, etc.) and was withdrawn as a therapy in 2010. Sildenafil, a type 5 PDEi, is well tolerated, largely used in impotence and has interesting clinical delay and duration of action in the concept of a potential use in claudication. Preliminary data from the literature and unpublished case reports, suggest that this drug could efficiently improve symptoms and walking capacity in patients with stage 2 claudication.
Trial Details
NCT Number NCT03686306
Lead Sponsor Rennes University Hospital
Conditions
(from sponsor)		 Peripheral Artery Disease
Related terms Peripheral Arterial Disease
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov