NCT02387450

Brief Summary

Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

March 2, 2015

Last Update Submit

March 12, 2015

Conditions

Peripheral Arterial Disease

Keywords

ClaudicationMaximal walking distanceMorbi-mortality

Outcome Measures

Primary Outcomes (1)

  • Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage)

    6 months

Secondary Outcomes (4)

  • Quality of life Questionnaire

    3, 6 and 9 months

  • Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event)

    3, 6 and 9 months

  • Walking capacity (treadmill test)

    3, 6 and 9 months

  • Proportion of revascularized patients

    6 and 9 months

Study Arms (2)

Treated group

ACTIVE COMPARATOR

Sildenafil, oral, 100mg per day

Drug: Sildenafil

Control group

PLACEBO COMPARATOR

placebo oral

Drug: Placebo

Interventions

SildenafilDRUG

100 mg per day

Also known as: Viagra or revatio
Treated group
PlaceboDRUG

Placebo with same presentation as the active drug

Control group

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ABI\<0.90
  • Vascular type claudication
  • stable walking impairment for at least 3 months
  • Optimal cardiovasc treatment (Anti-platelet, HMGCoA-Inh, ACE-Inh or AT2 inh)
  • Age \> 30 years

You may not qualify if:

  • Refuse to participate
  • Administrative protection
  • Severe renal (clearance \< 30 ml/min) or hepatic (Child-Pugh C) failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire

Angers, 49933, France

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseIntermittent Claudication

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • pierre Abraham, MD, PhD

    University Hospital in Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

pierre ABRAHAM, MD, PhD

CONTACT

+33 241353689piabraham@chu-angers.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 13, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations

FR(1)