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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2017-10-31

Brief Summary

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Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on treadmill of PAD patients with claudication

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Detailed Description

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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)

Conditions

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Peripheral Arterial Occlusive Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sildenafil

Single sildenafil oral intake (100 mg) approximately 2 hours before the treadmill test.

Group Type EXPERIMENTAL

Sildenafil 100mg single oral dose

Intervention Type DRUG

Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)

Placebo

Single placebo intake approximately 2 hours before the treadmill test.

Group Type PLACEBO_COMPARATOR

Placebo, Oral intake single dose

Intervention Type DRUG

Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)

Interventions

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Sildenafil 100mg single oral dose

Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)

Intervention Type DRUG

Placebo, Oral intake single dose

Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)

Intervention Type DRUG

Other Intervention Names

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Viagra verventi Sugar pills manufactured to mimick Sildenafil 100 mg

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No