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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03887520
Other study ID # CTQJ230A12001
Secondary ID 2018-003786-34
Status Completed
Phase N/A
First received
Last updated
Start date November 27, 2018
Est. completion date July 30, 2021

Study information

Verified date January 2022
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).


Recruitment information / eligibility

Status Completed
Enrollment 49001
Est. completion date July 30, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Signed informed consent - Established CVD defined as one of the following: - History of a myocardial infarction (MI) =3 months and =10 years before the study visit - History of ischemic stroke = 3 months and = 10 years before the study visit - Symptomatic PAD (intermitted claudication with ankle-brachial index =0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia Exclusion Criteria: - Patients currently enrolled in clinical studies with investigational drugs

Study Design


Intervention

Diagnostic Test:
Blood draw for Lp(a)
Collect sample for Lipoprotein(a) testing

Locations

Country Name City State
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Caba
Argentina Novartis Investigative Site Caba
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Cordoba
Argentina Novartis Investigative Site Cordoba
Argentina Novartis Investigative Site Corrientes
Argentina Novartis Investigative Site Formosa
Argentina Novartis Investigative Site Mar del Plata Buenos Aires
Argentina Novartis Investigative Site Ramos Mejia Buenos Aires
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site San Luis
Argentina Novartis Investigative Site San Miguel de Tucuman Tucuman
Argentina Novartis Investigative Site Santa Fe
Argentina Novartis Investigative Site Tucuman San Miguel De Tucuman
Australia Novartis Investigative Site Camperdown New South Wales
Australia Novartis Investigative Site Chemside Queensland
Australia Novartis Investigative Site Clayton Victoria
Australia Novartis Investigative Site Liverpool New South Wales
Australia Novartis Investigative Site Perth Western Australia
Australia Novartis Investigative Site Woolloongabba Queensland
Austria Novartis Investigative Site Graz
Austria Novartis Investigative Site Innsbruck
Austria Novartis Investigative Site Linz
Austria Novartis Investigative Site Salzburg
Austria Novartis Investigative Site Vienna
Austria Novartis Investigative Site Wien
Belgium Novartis Investigative Site Aalst
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Dendermonde
Belgium Novartis Investigative Site Genk
Belgium Novartis Investigative Site Gent
Belgium Novartis Investigative Site Huy
Belgium Novartis Investigative Site Mechelen
Belgium Novartis Investigative Site Tienen
Brazil Novartis Investigative Site Aracaju SE
Brazil Novartis Investigative Site Belo Horizonte MG
Brazil Novartis Investigative Site Belo Horizonte MG
Brazil Novartis Investigative Site Blumenau Santa Catarina
Brazil Novartis Investigative Site Brasilia DF
Brazil Novartis Investigative Site Campinas SP
Brazil Novartis Investigative Site Campinas SP
Brazil Novartis Investigative Site Campinas SP
Brazil Novartis Investigative Site Canoas RS
Brazil Novartis Investigative Site Caxias do Sul Porto Alegre
Brazil Novartis Investigative Site Curitiba PR
Brazil Novartis Investigative Site Curitiba Parana
Brazil Novartis Investigative Site Juiz de Fora MG
Brazil Novartis Investigative Site Maceio AL
Brazil Novartis Investigative Site Maringa PR
Brazil Novartis Investigative Site Porto Alegre RS
Brazil Novartis Investigative Site Porto Alegre RS
Brazil Novartis Investigative Site Ribeirao Preto SP
Brazil Novartis Investigative Site Rio de Janeiro
Brazil Novartis Investigative Site Salvador BA
Brazil Novartis Investigative Site Santo Andre SP
Brazil Novartis Investigative Site Santo Andre SP
Brazil Novartis Investigative Site Sao Jose do Rio Preto SP
Brazil Novartis Investigative Site Sao Jose do Rio Preto SP
Brazil Novartis Investigative Site Sao Paulo SP
Brazil Novartis Investigative Site Sao Paulo SP
Brazil Novartis Investigative Site Sao Paulo SP
Brazil Novartis Investigative Site Sao Paulo SP
Brazil Novartis Investigative Site Sao Paulo
Brazil Novartis Investigative Site São Paulo SP
Brazil Novartis Investigative Site Uberlandia Minas Gerais
Brazil Novartis Investigative Site Vitoria ES
Bulgaria Novartis Investigative Site Blagoevgrad
Bulgaria Novartis Investigative Site Burgas
Bulgaria Novartis Investigative Site Kardzhali
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Bulgaria Novartis Investigative Site Pernik
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Bulgaria Novartis Investigative Site Sofia
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Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Veliko Tarnovo
Canada Novartis Investigative Site Calgary Alberta
Canada Novartis Investigative Site Chicoutimi Quebec
Canada Novartis Investigative Site Gatineau Quebec
Canada Novartis Investigative Site Greenfield Park Quebec
Canada Novartis Investigative Site Levis Quebec
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Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Oakville Ontario
Canada Novartis Investigative Site Ottawa Ontario
Canada Novartis Investigative Site Quebec
Canada Novartis Investigative Site Quebec
Canada Novartis Investigative Site Quebec
Canada Novartis Investigative Site Sainte Foy Quebec
Canada Novartis Investigative Site Scarborough Ontario
Canada Novartis Investigative Site Sherbrooke Quebec
Canada Novartis Investigative Site Terrebonne Quebec
Canada Novartis Investigative Site Toronto Ontario
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Canada Novartis Investigative Site Vancouver British Columbia
Canada Novartis Investigative Site Vancouver British Columbia
Canada Novartis Investigative Site Victoria British Columbia
Canada Novartis Investigative Site Winnipeg Manitoba
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Chile Novartis Investigative Site Santiago RM
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Chile Novartis Investigative Site Vina del Mar Valparaiso
China Novartis Investigative Site Baotou Inner Mongolia
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Czechia Novartis Investigative Site Kromeriz Czech Republic
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Czechia Novartis Investigative Site Ostrava
Czechia Novartis Investigative Site Ostrava Czech Republic
Czechia Novartis Investigative Site Pardubice Czech Republic
Czechia Novartis Investigative Site Plzen Czech Republic
Czechia Novartis Investigative Site Prague 4 Czech Republic
Czechia Novartis Investigative Site Prague 5
Czechia Novartis Investigative Site Praha 10
Czechia Novartis Investigative Site Praha 2
Czechia Novartis Investigative Site Prerov
Czechia Novartis Investigative Site Svitavy Czech Republic
Czechia Novartis Investigative Site Trebic Czech Republic
Czechia Novartis Investigative Site Trutnov CZE
Czechia Novartis Investigative Site Uherske Hradiste
Czechia Novartis Investigative Site Usti nad Labem Czech Republic
Czechia Novartis Investigative Site Valasske Mezirici
Czechia Novartis Investigative Site Znojmo Czech Republic
Denmark Novartis Investigative Site Aalborg
Denmark Novartis Investigative Site Arhus N
Denmark Novartis Investigative Site Esbjerg
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Egypt Novartis Investigative Site Alexandria
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France Novartis Investigative Site Auxerre
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France Novartis Investigative Site Compiègne
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France Novartis Investigative Site Grenoble Cedex 9
France Novartis Investigative Site Le Chesnay
France Novartis Investigative Site Le Coudray
France Novartis Investigative Site Lille
France Novartis Investigative Site Limoges cedex
France Novartis Investigative Site Lyon Cedex 03
France Novartis Investigative Site Marseille Cedex 8
France Novartis Investigative Site Nice
France Novartis Investigative Site Nimes Cedex 09
France Novartis Investigative Site Orleans
France Novartis Investigative Site Paris
France Novartis Investigative Site Paris
France Novartis Investigative Site Paris
France Novartis Investigative Site Paris cedex 18
France Novartis Investigative Site Pessac
France Novartis Investigative Site Toulouse
France Novartis Investigative Site Tourcoing
France Novartis Investigative Site Valenciennes
Germany Novartis Investigative Site Aachen
Germany Novartis Investigative Site Bad Homburg
Germany Novartis Investigative Site Bad Oeynhausen
Germany Novartis Investigative Site Bamberg
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Bielefeld
Germany Novartis Investigative Site Bremen
Germany Novartis Investigative Site Bremen
Germany Novartis Investigative Site Chemnitz
Germany Novartis Investigative Site Chemnitz
Germany Novartis Investigative Site Chemnitz Saxony
Germany Novartis Investigative Site Dessau-Roßlau
Germany Novartis Investigative Site Dortmund
Germany Novartis Investigative Site Dresden
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Germany Novartis Investigative Site Dresden Sachsen
Germany Novartis Investigative Site Elsterwerda
Germany Novartis Investigative Site Erfurt
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Frankfurt am Main
Germany Novartis Investigative Site Fulda
Germany Novartis Investigative Site Gelnhausen
Germany Novartis Investigative Site Goch
Germany Novartis Investigative Site Greifswald
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover Niedersachsen
Germany Novartis Investigative Site Jena
Germany Novartis Investigative Site Kassel
Germany Novartis Investigative Site Kleve
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Germany Novartis Investigative Site Kuenzing
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Loehne
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Germany Novartis Investigative Site Lutherstadt Wittenberg
Germany Novartis Investigative Site Magdeburg
Germany Novartis Investigative Site Mannheim
Germany Novartis Investigative Site Mannheim Baden-Wuerttemberg
Germany Novartis Investigative Site Meißen
Germany Novartis Investigative Site Memmingen
Germany Novartis Investigative Site Muehldorf
Germany Novartis Investigative Site Muehldorf Am Inn
Germany Novartis Investigative Site Muenchen
Germany Novartis Investigative Site Muenchen
Germany Novartis Investigative Site Muenster
Germany Novartis Investigative Site Northeim
Germany Novartis Investigative Site Potsdam
Germany Novartis Investigative Site Rüdersdorf
Germany Novartis Investigative Site Saint Ingbert - Oberwuerzbach
Germany Novartis Investigative Site Schwaebisch Hall
Germany Novartis Investigative Site Siegen
Germany Novartis Investigative Site Stuttgart
Germany Novartis Investigative Site Trier
Germany Novartis Investigative Site Ulm
Germany Novartis Investigative Site Wangen
Germany Novartis Investigative Site Warendorf
Germany Novartis Investigative Site Wedel
Germany Novartis Investigative Site Weiden
Germany Novartis Investigative Site Witten
Greece Novartis Investigative Site Athens GR
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Chalkida
Greece Novartis Investigative Site Heraklion Crete
Greece Novartis Investigative Site Larissa GR
Greece Novartis Investigative Site Thessaloniki
Greece Novartis Investigative Site Voula GR
Guatemala Novartis Investigative Site Guatemala
Guatemala Novartis Investigative Site Guatemala
Guatemala Novartis Investigative Site Guatemala City
Guatemala Novartis Investigative Site Guatemala City
Guatemala Novartis Investigative Site Guatemala City
Guatemala Novartis Investigative Site Guatemala City
Guatemala Novartis Investigative Site Quetzaltenango
Hong Kong Novartis Investigative Site Hongkong
Hong Kong Novartis Investigative Site Pokfulam
Hungary Novartis Investigative Site Baja
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
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Hungary Novartis Investigative Site Szeged
Hungary Novartis Investigative Site Szeged
Hungary Novartis Investigative Site Szekesfehervar
Iceland Novartis Investigative Site Kopavogur
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India Novartis Investigative Site Ahmedabad Gujarat
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Israel Novartis Investigative Site Tel Giborim, Holon
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Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czechia,  Denmark,  Egypt,  France,  Germany,  Greece,  Guatemala,  Hong Kong,  Hungary,  Iceland,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Malaysia,  Mexico,  Netherlands,  Norway,  Peru,  Philippines,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with normal and elevated Lipoprotein(a) (Lp(a)) levels in patients with established Cardiovascular Disease (CVD) Prevalence of normal and elevated Lp(a) levels in patients with established CVD At screening
Secondary Lipoprotein(a) (Lp(a)) values Evaluate the median and other relevant statistics describing the distribution of Lp(a) within the normal range and elevated Lp(a) levels At screening
Secondary Lp(a) values by region and country Evaluate the median and other relevant statistics describing the distribution of Lp(a) by region and country At screening
Secondary Low-density lipoprotein cholesterol (LDL(C)) values (corrected and uncorrected) Evaluate the median and other relevant statistics describing the distribution of LDL-C (corrected and uncorrected) within the normal range and with elevated Lp(a) levels At screening
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04023552 - Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD Phase 3