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Onderzoek naar de veiligheid en veiligheid bij adolescenten met heterozygote familiale hypercholesterolemie

Tweevoudige Inclisiran versus placebo [jaar 1] gevolgde door open-label Inclisiran [jaar 2]) gerandomiseerde multicenter studie om de veiligheid, verdraagbaarheid enheid van inclisiran te openen bij adolescenten (12 tot minder dan 18 jaar) met heterozygote familiale Hypercholesterolemie en later LDL- cholesterol (ORION-16)

Sponsors

Hoofdsponsor: Novartis Pharmaceuticals

Bron Novartis
Korte samenvatting

Dit is een cruciale fase III-studie die is ontworpen om veiligheid, draagbaarheid en werking van inclisiran bij adolescenten met heterozygote familiaire hypercholesterolemie (HeFH) en verhoogde lipoproteïne-cholesterol met lage dichtheid (LDL-C).

gedetailleerde beschrijving

Dit is een tweedelig (1 jaar dubbelblind inclisiran versus placebo / 1 jaar open-label) inclisiran) multicenter onderzoek ontworpen om de veiligheid, verdraagbaarheid en werkzaamheid van inclisiran bij adolescenten met heterozygote familiaire hypercholesterolemie (HeFH) en verhoogde lipoproteïne-cholesterol met lage dichtheid (LDL-C) op stabiele zorgstandaard lipidenverlagende therapie. Het primaire doel is om superioriteit van inclisiran. aan te tonen met placebo bij het verlagen van LDL-C (procentuele verandering) op dag 330.

Algemene status Rekruteren
Startdatum 2021-01-27
einddatum 2023-12-07
Primaire voltooiingsdatum 2022-11-14
Fase Fase 3
Studietype Interventionele
Primaire uitkomst
Meten Tijdsspanne
Percentage (%) verandering in low-density lipoproteïne-cholesterol (LDL-C) vanaf baseline tot dag 330 Basislijn en dag 330
Secundair resultaat
Meten Tijdsspanne
Time-adjusted % change in LDL-C from baseline after Day 90 and up to Day 330 Baseline, after Day 90 up to Day 330
Absolute verandering in LDL-C vanaf baseline tot dag 330 Basislijn en dag 330
% verandering in apolipoproteïne B (Apo B), lipoproteïne (a) [Lp(a)], non-high-density lipoproteïnecholesterol (niet-HDL-C) en totaal cholesterol vanaf baseline tot dag 330 Basislijn en dag 330
% verandering en absolute verandering in LDL-C vanaf baseline tot dag 720 Basislijn, tot dag 720
% verandering en absolute verandering in andere lipoproteïnen en lipideparameters vanaf baseline tot dag 720 Basislijn, tot dag 720
% verandering en absolute verandering in proproteïne convertase subtilisine/kexine type 9 (PCSK9) vanaf baseline tot dag 720 Basislijn, tot dag 720
Inschrijving 150
Staat
Interventie

Type interventie: Drug

Interventienaam: Inclisiran

Omschrijving: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL solution for subcutaneous injection

Armgroeplabel: Inclisiran

Andere naam: KJX839

Type interventie: verdovende middelen

Interventienaam: Placebo

Omschrijving: Steriele normale zoutoplossing (0,9% natriumchloride in water voor onderhuidse injectie)

Armgroeplabel: Placebo

Andere naam: Zoutoplossing

Geschiktheid

Criteria:

Inclusiecriteria: - Heterozygote familiaire hypercholesterolemie (HeFH) door middel van genetische tests van op fenotypische criteria - Nuchter LDL-C >130 mg/dL (3,4 mmol/L) bij screening - Nuchtere triglyceriden

Geslacht:

Alle

Minimum leeftijd:

12 jaar

Maximale leeftijd:

17 jaren

Gezonde vrijwilligers:

Nee

Algemeen ambtenaar
Achternaam Rol Verbondenheid
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Algemeen contact

Achternaam: Novartis Pharmaceuticals

Telefoon: 1-888-669-6682

E-mail: [email protected]

Plaats
Faciliteit: Toestand: Contact: Onderzoeker:
Excel Medical Clinical Trials LLC | Boca Raton, Florida, 33434, United States Recruiting 561-756-8206 [email protected] Seth Baum, MD Principal Investigator
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Recruiting 314-362-8681 [email protected] Anne Goldberg, MD Principal Investigator
Icahn School of Medicine at Mount Sinai | New York, New York, 10029, United States Recruiting 212-659-9174 [email protected] Robert Rosenson, MD Principal Investigator
University of Tennessee Health Science Center | Memphis, Tennessee, 38163, United States Recruiting 901-448-4166 [email protected] John Jefferies, MD Principal Investigator
Novartis Investigative Site | Woolloongabba, Queensland, 4102, Australia Recruiting
Novartis Investigative Site | Fortaleza, Ceara, 60430275, Brazil Recruiting
Nucleo de Pesquisa Clinica do Rio Grande do Sul | Porto Alegre, RS, 90430-001, Brazil Recruiting Luis Canani, MD +555137796400 [email protected]
Novartis Investigative Site | Sao Paulo, SP, 04023-900, Brazil Recruiting
Heart Institute (InCOr) HCMFUSP | Sao Paulo, SP, 05403 000, Brazil Recruiting Raul Santos Filho, Prof. Dr. +55 11994822460 [email protected]
Novartis Investigative Site | Vancouver, British Columbia, V6Z 1Y6, Canada Recruiting
Novartis Investigative Site | London, Ontario, N6A 5A5, Canada Recruiting
Novartis Investigative Site | Quebec, G1V 4W2, Canada Recruiting
Novartis Investigative Site | Zagreb, 10000, Croatia Recruiting
Novartis Investigative Site | Bron Cedex, 69677, France Recruiting
Novartis Investigative Site | Toulouse Cedex, 31059, France Recruiting
Universitaetsmedizin Mannheim | Mannheim, Baden-Wuerttemberg, 68305, Germany Recruiting Claudia Foellinger +49 (0) 623 832751 [email protected]
Novartis Investigative Site | Frankfurt, 60590, Germany Recruiting
Novartis Investigative Site | Freiburg, 79106, Germany Recruiting
Novartis Investigative Site | Ioannina, GR, 455 00, Greece Recruiting
Hippokrateion General Hospital of Athens Greece | Athens, 115 27, Greece Recruiting Charalambos Vlachopoulos, Professor +30 6972272727 [email protected]
Metropolitan Hospital | Athens, 18547, Greece Recruiting Genovefa Kolovou, Director Cardiologist +30 210 4807139 [email protected]
Hippokratiou Hospital, Thessaloniki, Greece | Thessaloniki, 54642, Greece Recruiting Michael Doumas, Assoc Prof Internal Medicine +30 2310 892070 [email protected]
Novartis Investigative Site | Budapest, 1085, Hungary Recruiting
Novartis Investigative Site | Pecs, 7623, Hungary Recruiting
Lipid Research | Jerusalem, 9112001, Israel Recruiting Shoshi Shpitzen, Trial Coordinator +9722 6776897 [email protected]
Lipids Center Sheba Medical Center, Israel | Ramat Gan, 52621, Israel Recruiting 972 35303492 [email protected] Hofit Cohen Principal Investigator
Novartis Investigative Site | Milano, MI, 20162, Italy Recruiting
Novartis Investigative Site | Modena, MO, 41124, Italy Recruiting
Novartis Investigative Site | Roma, RM, 00100, Italy Recruiting
Novartis Investigative Site | Ashrafieh, 166830, Lebanon Recruiting
Novartis Investigative Site | Sungai Buloh, Selangor Darul Ehsan, 47000, Malaysia Recruiting
Novartis Investigative Site | Kuala Lumpur, 59100, Malaysia Recruiting
Novartis Investigative Site | Amsterdam, 1105 AZ, Netherlands Recruiting
Novartis Investigative Site | Rotterdam, 3015 GD, Netherlands Recruiting
Novartis Investigative Site | Oslo, 0514, Norway Recruiting
Novartis Investigative Site | Lodz, 93-338, Poland Recruiting
Novartis Investigative Site | Kazan, 420012, Russian Federation Recruiting
Research Institute for Complex Issues of Cardiovascular Disease | Kemerovo, 650002, Russian Federation Recruiting Vasily Kashtalap, Dr. +73842643153 [email protected]
Novartis Investigative Site | Moscow, 127412, Russian Federation Recruiting
Institute of Internal Prev. Med. | Novosibirsk, 630090, Russian Federation Recruiting Mikhail Voyevoda, Prof. +7 913 950 50 88 [email protected]
Novartis Investigative Site | Singapore, 229899, Singapore Recruiting
Novartis Investigative Site | Ljubljana, 1000, Slovenia Recruiting
Novartis Investigative Site | Bloemfontein, Free State, 9301, South Africa Recruiting
Novartis Investigative Site | Pretoria, Gauteng, 0184, South Africa Recruiting
Novartis Investigative Site | Somerset West, Western Cape, 7130, South Africa Recruiting
Novartis Investigative Site | Cape Town, 7925, South Africa Recruiting
Novartis Investigative Site | Cordoba, Andalucia, 14004, Spain Recruiting
Novartis Investigative Site | Malaga, Andalucia, 29010, Spain Recruiting
Novartis Investigative Site | Sevilla, Andalucia, 41013, Spain Recruiting
Novartis Investigative Site | Barcelona, Catalunya, 08036, Spain Recruiting
Novartis Investigative Site | Pamplona, Navarra, 31008, Spain Recruiting
Novartis Investigative Site | A Coruna, 15001, Spain Recruiting
Novartis Investigative Site | Geneve 14, 1211, Switzerland Recruiting
Novartis Investigative Site | New Taipei, 22060, Taiwan Recruiting
Novartis Investigative Site | Taipei, 11217, Taiwan Recruiting
Novartis Investigative Site | Istanbul, TUR, 34098, Turkey Recruiting
Novartis Investigative Site | Ankara, 06490, Turkey Recruiting
Novartis Investigative Site | Ankara, 06500, Turkey Recruiting
Novartis Investigative Site | Istanbul, 34093, Turkey Recruiting
Novartis Investigative Site | Izmir, 35040, Turkey Recruiting
Novartis Investigative Site | Bromwich, B71 4HJ, United Kingdom Recruiting
Novartis Investigative Site | Middlesex, UB9 6JH, United Kingdom Recruiting
Locatie Landen

Australia

Brazil

Canada

Croatia

France

Germany

Greece

Hungary

Israel

Italy

Lebanon

Malaysia

Netherlands

Norway

Poland

Russian Federation

Singapore

Slovenia

South Africa

Spain

Switzerland

Taiwan

Turkey

United Kingdom

United States

Verificatiedatum

2021-10-01

Verantwoordelijke partij

Type: Sponsor

Sleutelwoorden
Heeft uitgebreide toegang Nee
Aantal wapens 2
Arm groep

Label: Inclisiran

Type: Experimental

Omschrijving: Year 1 - inclisiran sodium 300 mg subcutaneous injection (given at Days 1, 90, and 270) Day 360 only - placebo subcutaneous injection Year 2 - inclisiran sodium 300 mg subcutaneous injection (given at Days 450 and 630)

Label: Placebo

Type: Placebo-vergelijker

Omschrijving: Jaar 1 - placebo subcutane injectie (gegeven op dag 1, 90 en 270) Jaar 2 - inclisiran natrium 300 mg subcutane injectie (gegeven op dag 360, 450 en 630)

Acroniem ORION-16
Bestudeer ontwerpinformatie

Toewijzing: Gerandomiseerd

Interventiemodel: Parallelle toewijzing

Interventiemodel Beschrijving: Parallel (jaar 1) naar enkele groep (jaar 2)

Primair doel: behandeling

Maskeren: Dubbel (deelnemer, onderzoeker)

Masking Beschrijving: Gemaskeerd (jaar 1) tot geen maskering (jaar 2)

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