Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication

NCT02930811 | Withdrawn Phase 3 DMC

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

Brief Summary

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 the most common clinical feature of PAD. Primary therapeutic approach is medical treatment and advice to walk. Sildenafil, a PDEi type 5, 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. For patients agreeing and signing informed consent, randomisation of treatment (placebo/sildenafil) will be done. Treatment will be proposed in addition to usual treatment. The experimental drug will be delivered for a 1 month treatment. First follow up visit at month one will focus on tolerance, compliance and eventual side effects. If no major side effect is found the study drug will then be delivered for an additional 2 months. Patients will be evaluated at month 3 (second follow-up visit) for persistent or non-persistent indication for revascularisation and addressed for revascularization if needed. In parallel focus on tolerance, compliance and eventual side effects will be done. If no major side effect is found, the study drug will be delivered for an additional 3 months treatment. Third and fourth follow-up visit are scheduled at month 6 (end of treatment) and month 9 (3 months after the end of experimental drugs).

Conditions

Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• Improvement of Event free survival rate

  Event free survival is defined as the time between inclusion date and the date of event occurrence. If no event is observed at the follow-up period, event free survival is defined as the delay of follow-up

  6 months after the treatment begining

Study Arms (2)

Sildenafil

EXPERIMENTAL

Single Sildenafil oral morning intake (100mg/day) per day for a total duration of 6 months (Sildenafil 100 mg oral morning dose)

Drug: Sildenafil 100 mg oral morning dose

Placebo

PLACEBO COMPARATOR

Single Placebo oral morning intake per day for a total duration of 6 months (Placebo oral morning dose)

Drug: Placebo oral morning dose

Interventions

Sildenafil 100 mg oral morning dose DRUG

Measurement of maximal walking distance on a constant load treadmill test, SF-36 questionnaire, and Edimburg questionnaire at inclusion, 1 month, 3 month and 6 month. Events occurence questionnaires, Tolerance and adverse events questionnaire, Welch questionnaire and walk recommendation at inclusion, 7 days, 14 days, 1-2-3-4-5-6 and 9 months

Also known as: Experimental: Sildenafil

Sildenafil

Placebo oral morning dose DRUG

Measurement of maximal walking distance on a constant load treadmill test, SF-36 questionnaire, and Edimburg questionnaire at inclusion, 1 month, 3 month and 6 month. Events occurence questionnaires, Tolerance and adverse events questionnaire, Welch questionnaire and walk recommendation at inclusion, 7 days, 14 days, 1-2-3-4-5-6 and 9 months

Also known as: Placebo Comparator: Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Grade I cat 2 or 3 claudication despite optimal medical treatment
• Reporting a vascular claudication history for at least 3 months
• Able to achieve a walking treadmill test, Walking time on treadmill (3.2km/h, 10% slope) less than 5 minutes
• Having no cons Sildenafil indication
• Must be on optimal medical therapy (ACE Inhibitors / AT2 Antagonist + Antiplatelet + Lipid Lowering drugs) for at least 1 month

You may not qualify if:

• Critical ischemia
• Previous history of myocardial infarction or angina not stabilized
• Amblyopia
• Treated with nitrates (nitroglycerin ...) or drugs interfering with the action of the Sildenafil
• Pregnant woman and woman in labor
• Major Person subject to reinforced protection, deprived of their liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than research

Sponsors & Collaborators

• University Hospital, Angers: lead

Related Publications (1)

• Omarjee L, Camarzana A, Henni S, Abraham P. Nonrevascularizable buttock claudication improved with Sildenafil: A case report. Medicine (Baltimore). 2017 Feb;96(8):e6186. doi: 10.1097/MD.0000000000006186.

  PMID: 28225505 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

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Primary Completion: October 1, 2022
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share