Who is sponsoring NCT04306081?

NCT04306081 is sponsored by Leonardo Clavijo.

What condition does NCT04306081 study?

NCT04306081 studies Peripheral Arterial Disease.

Is NCT04306081 still recruiting?

NCT04306081 is currently status unknown. Last updated 12 March 2020.

Last reviewed 2020-03-12 · How we verify

NCT04306081: Evol-PAD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Evolocumab in Functional Status and LDL Oxidation of Patients With Peripheral Arterial Disease

Status unknown Phase 4 Last updated 12 March 2020

What this trial tests

Phase 4 trial testing Evolocumab 140 mg/mL Subcutaneous Injection 1 milliliter (mL) pre-filled injector Pen x 3 for a monthly dose of 420 mg for 6 months. in Peripheral Arterial Disease in 86 participants. Status unknown.

Timeline

14 December 2017

Primary endpoint
30 December 2020

30 March 2021

Quick facts

Lead sponsor	Leonardo Clavijo
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	86
Start date	14 December 2017
Primary completion	30 December 2020
Estimated completion	30 March 2021
Sites	1 location across United States

Drugs / interventions tested

Evolocumab 140 mg/mL Subcutaneous Injection 1 milliliter (mL) pre-filled injector Pen x 3 for a monthly dose of 420 mg for 6 months.
Placebo 1milliliter (mL) Subcutaneous Injection pre-filled injector Pen x 3 monthly for 6 months.

Conditions studied

Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →

Sponsor

Leonardo Clavijo — full company profile →

Who can join

Adults 40 to 85, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Peripheral arterial disease (PAD) is a manifestation of systemic atherosclerotic cardiovascular disease (ASCVD) and is associated with increase cardiovascular risk. PAD impairs quality of life due to symptoms of claudication, pain at rest or risk of limb loss. All major societies recognize the importance of LDL reduction in patients with PAD. Statin therapy improves cardiovascular end-points in patients with PAD and have been shown to improve symptoms of lower extremity intermittent claudication (pain free walking time), 6-minute walking time, ankle-brachial index (ABI), and endothelial function, while decreasing markers of atherosclerosis. This study aims to demonstrate that in patients with PAD on stable maximal tolerated lipid lowering regimen with a statin, further reduction of LDL with the pro protein converts subtilisin/kexin type 9 (PCSK-9) inhibitor Evolocumab, improves functional status (pain free walking time in particular, but also maximal walking time), lower extremity arterial perfusion and endothelial function (brachial endothelial reactivity).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Currently open trials in the same condition.

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Other Leonardo Clavijo trials

Trials by the same sponsor.

NCT04306471 — Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI) · Phase 4 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04306081 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Leonardo Clavijo
Last refreshed: 12 March 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04306081.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing