- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07919405
A Research Study to Investigate How Well the Medicine CagriSema Lowers High Blood Pressure in People Living With High Blood Pressure and Obesity (REDEFINE)
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) in Participants With Hypertension and Obesity
This study is testing whether CagriSema is safe and works well in adults with high blood pressure and excess body weight. Participants will receive CagriSema, semaglutide, cagrilintide, or placebo, and treatment will be assigned by chance. CagriSema and cagrilintide are investigational medicines, while semaglutide is already available by prescription.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Novo Nordisk
- Puhelinnumero: (+1) 866-867-7178
- Sähköposti: clinicaltrials@novonordisk.com
Opiskelupaikat
-
-
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Deventer, Alankomaat, 7416 SE
- Deventer Ziekenhuis - Interne geneeskunde
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Dordrecht, Alankomaat, 3318 AT
- Albert Schweitzer Zkh, Dordwijk - Nefrologie
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Eindhoven, Alankomaat, 5623 EJ
- Catharina Zkh Eindhoven - Interne geneeskunde
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Haarlem, Alankomaat, 2035 RC
- Spaarne Gasthuis Haarlem - Interne
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Heerlen, Alankomaat, 6419 PC
- Zuyderland ziekenhuis - Interne
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Hoogeveen, Alankomaat, 7909 AA
- Bethesda Diabetes Research Center
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Nijmegen, Alankomaat, 6525 GA
- RadboudUMC - Vasculaire geneeskunde
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Utrecht, Alankomaat, 3584 CX
- UMC Utrecht - Vasculaire geneeskunde
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Buenos Aires, Argentiina, C1425AGC
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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CABA, Argentiina, C1060ABA
- CEDIC Centro de Investigación Clínica
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CABA, Argentiina, C1120AAC
- Centro Médico Viamonte SRL
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Rosario, Argentiina, S2000PBJ
- CAICI
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Santiago del Estero, Argentiina, G4200
- Sanatorio Norte
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Buenos Aires
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CABA, Buenos Aires, Argentiina, C1128 AAF
- Mautalen Salud e investigación
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CABA, Buenos Aires, Argentiina, C1440CFD
- CEMEDIC
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Capital Federal, Buenos Aires, Argentiina, C1056ABI
- Centro de Investigaciones Metabólicas
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La Pampa Province
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Santa Rosa, La Pampa Province, Argentiina, 6300
- Fundación CESIM
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Mendoza Province
-
Godoy Cruz, Mendoza, Mendoza Province, Argentiina, 5501
- Hospital Español de Mendoza
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New South Wales
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Castle Hill, New South Wales, Australia, 2154
- Castle Hill Medical Centre
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Darlinghurst, New South Wales, Australia, 2010
- Momentum Clinical Research Darlinghurst
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Maroubra, New South Wales, Australia, 2035
- Australian Clinical Research Network
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Sydney, New South Wales, Australia, 2148
- Roger Chih Yu Chen
-
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Queensland
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Douglas, Queensland, Australia, 4814
- Townsville University Hospital
-
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Victoria
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Torquay, Victoria, Australia, 3228
- Clinical Trials Institute
-
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Western Australia
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Bunbury, Western Australia, Australia, 6230
- Brecken Health Clinical Trials
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Perth, Western Australia, Australia, 6000
- Dobney Hypertension Centre
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Alken, Belgia, 3570
- Anima Research Center
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Bonheiden, Belgia, 2820
- Imelda
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Genk, Belgia, 3600
- Ziekenhuis Oost-Limburg
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Ghent, Belgia, 9000
- Universitair Ziekenhuis Gent
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Leuven, Belgia, 3000
- Uz Leuven
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Mons, Belgia, 7000
- CHU Helora - Hôpital de Mons - Site Constantinople
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilia, 30455-610
- Centro Universitário de Belo Horizonte (UNIBH)
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Paraná
-
Curitiba, Paraná, Brasilia, 80230-130
- PUCPR - Pontificia Universidade Catolica do Parana
-
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São Paulo
-
Bragança Paulista, São Paulo, Brasilia, 12916-542
- Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista
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Campinas, São Paulo, Brasilia, 13092-133
- i9 Pesquisas Clínicas
-
Campinas, São Paulo, Brasilia, 13060-803
- PUCCAMP - Hospital e Maternidade Celso Pierro
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Campinas, São Paulo, Brasilia, 13083-887
- Centro de Pesquisa Clínica da Faculdade de Ciências Médicas - Unicamp
-
São Paulo, São Paulo, Brasilia, 05403-000
- Instituto do Coração - HCFMUSP
-
São Paulo, São Paulo, Brasilia, 04038-032
- IBTED Tecnologia e Educação em Diabetes - EPP
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São Paulo, São Paulo, Brasilia, 01228-000
- CPQuali Pesquisa Clínica Ltda
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Burgas, Bulgaria, 8000
- Medical center Medconsult Burgas OOD
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Panagyurishte, Bulgaria, 4500
- MHAT - Uni Hospital OOD, Clinic of Cardiology
-
Pernik, Bulgaria, 2308
- MHAT Rahila Angelova AD, Research Center
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Plovdiv, Bulgaria, 4002
- Dr. Ilcho Ilchev - AIPSMC - Cardiology EOOD
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Shumen, Bulgaria, 9700
- MHAT Shumen AD
-
Sliven, Bulgaria, 8800
- GPSMC - Inacor OOD
-
Sofia, Bulgaria, 1202
- DCC Ascendent OOD
-
Sofia, Bulgaria, 1231
- MC Dr. Atanasov EOOD
-
Sofia, Bulgaria, 1510
- MC Hera EOOD - Sofia
-
Sofia, Bulgaria, 1431
- UMHAT Aleksandrovska EAD, Clinic of Cardiology
-
Sofia, Bulgaria, 1750
- MHAT Sveta Anna Sofia AD, Clinic of Cardiology
-
Sofia, Bulgaria, 1527
- UMHAT Tsaritsa Yoanna - ISUL EAD, Cardiology
-
Sofia, Bulgaria, 1612
- Nevrovita - Medical Center OOD
-
Varna, Bulgaria, 9010
- UMHAT Sveta Marina EAD, Clinic of Internal Diseases
-
Varna, Bulgaria, 9009
- SHATC - Cardiolife OOD - Varna
-
-
-
-
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Badajoz, Espanja, 06080
- Hospital Universitario de Badajoz
-
Barcelona, Espanja, 08022
- Centro Médico Quirón-Teknon
-
Barcelona, Espanja, 08036
- Clinic Barcelona_Endocrinología
-
León, Espanja, 24008
- H. de León_Endocrinología
-
Madrid, Espanja, 28016
- Hospital Universitario Sanitas Virgen del Mar
-
Madrid, Espanja, 28009
- H.G.Marañón_Endocrino-Obesidad
-
Santander, Espanja, 39008
- H. Univ. Marqués de Valdecilla_Endocrinología
-
Santiago de Compostela, Espanja, 15702
- Clínica Gaias Santiago
-
-
-
-
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Busan, Etelä -Korea, 49201
- Dong-A University Hospital_Family Medicine
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Daegu, Etelä -Korea, 41944
- Kyungpook National University Hospital_Family Medicine
-
Daegu, Etelä -Korea, 42601
- Keimyung University Dongsan Hospital_Endocrinology
-
Daejeon, Etelä -Korea, 35365
- Konyang University Hospital_Family Medicine
-
Seoul, Etelä -Korea, 03722
- Severance Hospital, Yonsei University Health System_Family Medicine
-
Seoul, Etelä -Korea, 04763
- Hanyang University Seoul Hospital_Family Medicine
-
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Gyeonggi-do
-
Anyang-si, Gyeonggi-do, Etelä -Korea, 14068
- Hallym University Sacred Heart Hospital_Family Medicine
-
Bucheon-si, Gyeonggi-do, Etelä -Korea, 14647
- The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
-
Seongnam-si, Gyeonggi-do, Etelä -Korea, 13620
- Seoul National University Bundang Hospital_Family Medicine
-
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Gyeongsangnam-do
-
Yangsan, Gyeongsangnam-do, Etelä -Korea, 50612
- Pusan National University Yangsan Hospital_Family Medicine
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Gauteng
-
Johannesburg, Gauteng, Etelä-Afrikka, 2013
- Wits Bara Clinical Trial Site
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Johannesburg, Gauteng, Etelä-Afrikka, 1818
- Soweto Clinical Trial Centre
-
Midrand, Gauteng, Etelä-Afrikka, 1685
- Dr A Jacovides and Partners Inc
-
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KwaZulu-Natal
-
Durban, KwaZulu-Natal, Etelä-Afrikka, 4091
- Dr Vawda's site
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eMkhomazi, KwaZulu-Natal, Etelä-Afrikka, 4170
- Dr T Padayachee
-
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Lenasia
-
Gauteng, Lenasia, Etelä-Afrikka, 1827
- Dr Moosa's Rooms
-
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Apulia
-
Bari, Apulia, Italia, 70124
- AUO Consorziale Policlinico Bari - UOC Medicina Interna Universitaria (Cesare Frugoni)
-
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Calabria
-
Catanzaro, Calabria, Italia, 88100
- AOU Renato Dulbecco - Unità Operativa Complessa Medicina Interna
-
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Emilia-Romagna
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Ferrara, Emilia-Romagna, Italia, 44124
- Arcispedale Sant'Anna (Cona) - Medicina Interna Universitaria
-
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Lazio
-
Rome, Lazio, Italia, 00189
- Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Cardiologia
-
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Lombardy
-
Brescia, Lombardy, Italia, 25123
- Spedali Civili Brescia - U.O. Medicina Generale 2
-
Milan, Lombardy, Italia, 20162
- Grande Ospedale Metropolitano Niguarda - Dipartimento di Cardiologia Clinica
-
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Molise
-
Pozzilli (IS), Molise, Italia, 86077
- NeuroMed S.p.A. - Dipartimento di Angio-Cardio-Neurologia
-
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RM
-
Rome, RM, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCS
-
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Sicily
-
Palermo, Sicily, Italia, 90127
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
-
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The Marches
-
Ancorna, The Marches, Italia, 60127
- INRCA Ancona - UOC Clinica Medica e Geriatrica
-
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Tuscany
-
Siena, Tuscany, Italia, 53100
- Azienda Ospedaliero Universitaria Senese - Endocrinologia
-
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Veneto
-
Padova, Veneto, Italia, 35128
- Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica
-
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Arakawa-ku, Tokyo, Japani, 116-0012
- Kumanomae Nishimura Naika Clinic_Internal Medicine
-
Okayama, Japani, 700-8558
- Okayama University Hospital_Neph. and Diabetes, Metabolism
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Sendai-shi, Miyagi, Japani, 983-0039
- Shinden Higashi Clinic_Internal medicine
-
Tokyo, Japani, 103-0027
- Tokyo-Eki Center-building Clinic_Internal Medicine
-
Tokyo, Japani, 104-0031
- Fukuwa Clinic_Internal Medicine
-
Tokyo, Japani, 160-0004
- Clinical Research Hospital Tokyo_Internal medicine
-
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Kanagawa
-
Yamato-shi, Kanagawa, Japani, 242-0004
- Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
-
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Québec, Kanada, G1V 4T3
- Diex Recherche Quebec
-
Québec, Kanada, G1V 4G5
- IUCPQ - Universite Laval
-
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British Columbia
-
Vancouver, British Columbia, Kanada, V6Z 2T1
- Spectrum Health Clinic
-
Victoria, British Columbia, Kanada, V8V 4A1
- Dr. M.B. Jones Inc
-
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New Brunswick
-
Moncton, New Brunswick, Kanada, E1G 1A7
- G.A. Research Associates Ltd.
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3H 1V7
- Nova Scotia Health Authority
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8L 5G4
- Premier Clinical Trial Research Network (PCTRN)
-
Hamilton, Ontario, Kanada, L8L 5G4
- Hamilton Medical Research Group
-
London, Ontario, Kanada, N5W 6A2
- Milestone Research
-
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Quebec
-
Trois-Rivières, Quebec, Kanada, G9A 4P3
- Diex Recherche Trois-Rivieres
-
-
-
-
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Ponce, Puerto Rico, 00716
- Ponce Med School Found Inc
-
-
-
-
-
Elblag, Puola, 82-300
- Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
-
Gdansk, Puola, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Gdansk, Puola, 80-462
- Copernicus Podmiot Leczniczy Sp. z o.o.
-
Krakow, Puola, 30-721
- Linden sp. z o.o. sp. k.
-
Krakow, Puola, 31-322
- Gyncentrum Sp. z o. o.
-
Lodz, Puola, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
-
Rzeszów, Puola, 35-205
- EMED Centrum Usług Medycznych Ewa Smialek
-
Siedlce, Puola, 08-110
- Lukmed 2 Sp. z o.o.
-
Starachowice, Puola, 27-200
- Star Badania Kliniczne Sp. z o.o
-
Warsaw, Puola, 04-628
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
-
Świnoujście, Puola, 72-600
- Balticmed Świnoujście Sp. z o. o.
-
-
Masovian Voivodeship
-
Grodzisk Mazowiecki, Masovian Voivodeship, Puola, 05-825
- Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II
-
Ostrów Mazowiecka, Masovian Voivodeship, Puola, 07-300
- Kresmed Sp. z o. o.
-
Warsaw, Masovian Voivodeship, Puola, 04-635
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
-
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Pomeranian Voivodeship
-
Gdynia, Pomeranian Voivodeship, Puola, 81-157
- Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
-
-
-
-
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Berlin, Saksa, 13405
- KARDIA - Dr. Hashemi
-
Duisburg, Saksa, 47269
- MVZ Hausärzte Großenbaum GmbH Duisburg
-
Elsterwerda, Saksa, 04910
- Zentrum für klinische Studien Südbrandenburg GmbH
-
Frankfurt, Saksa, 60590
- Uniklinik FFM - Nephrologie
-
Hamburg, Saksa, 22607
- Wendisch - Dahl Hamburg - DZHW
-
Münster, Saksa, 48145
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
-
Oldenburg in Holstein, Saksa, 23758
- RED-Institut für medizinische Forschung und Fortbildung GmbH
-
-
-
-
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Herning, Tanska, 7400
- Regionshospitalet Gødstrup - Universitetsklinikken for Nyresygdomme og Blodtryksforhøjelse
-
Holbæk, Tanska, 4300
- Holbæk Sygehus - Forskningsenheden, Medicinsk Afdeling, afs. 44-4
-
Hvidovre, Tanska, 2650
- Hvidovre Hospital Endokrinologisk forsknings afsnit 159
-
Viborg, Tanska, 8800
- Viborg Sygehus
-
-
Region Syddanmark
-
Esbjerg, Region Syddanmark, Tanska, 6700
- Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
-
-
-
-
-
Budapest, Unkari, H-1141
- Cardiogeneral Kft.
-
Budapest, Unkari, 1046
- Újpesti Egészségközpont
-
Budapest, Unkari, H-1021
- Budapesti Szent Ferenc Kórház
-
Békéscsaba, Unkari, 5600
- Trial Pharma Kft.
-
Békéscsaba, Unkari, 5600
- Békés Vármegyei Központi Kórház
-
Szeged, Unkari, 6724
- KomplexLabor Diagnosztika Kft.
-
-
Bács-Kiskun county
-
Kalocsa, Bács-Kiskun county, Unkari, 6300
- Stúdium Egészségház Kft.
-
-
Hajdú-Bihar
-
Debrecen, Hajdú-Bihar, Unkari, 4032
- Debreceni Egyetem
-
-
-
-
-
Bristol, Yhdistynyt kuningaskunta, BS37 4AX
- West Walk Surgery
-
Cambridge, Yhdistynyt kuningaskunta, CB2 0QQ
- Addenbrooke's Hospital_Cambridge
-
Chippenham, Yhdistynyt kuningaskunta, SN14 6GT
- Hathaway Medical Centre
-
Harrow, Yhdistynyt kuningaskunta, HA3 7LT
- Belmont Health Centre
-
Hounslow, Yhdistynyt kuningaskunta, TW4 7NJ
- HMC Health - Heston - The Meadows Centre for Health
-
London, Yhdistynyt kuningaskunta, EC1M 6BQ
- William Harvey Research Institute
-
London, Yhdistynyt kuningaskunta, SW1P 2PF
- Healthcare Central London - South Westminster Centre for Health
-
-
Cambridgeshire
-
Wisbech, Cambridgeshire, Yhdistynyt kuningaskunta, PE13 3UZ
- Trinity Surgery
-
-
Cornwall
-
Newquay, Cornwall, Yhdistynyt kuningaskunta, TR7 1RU
- Newquay Health Centre
-
-
Hertfordshire
-
Bushey, Hertfordshire, Yhdistynyt kuningaskunta, WD23 2NN
- Attenborough Surgery
-
-
-
-
California
-
Concord, California, Yhdysvallat, 94520
- John Muir Physicians Network
-
Costa Mesa, California, Yhdysvallat, 92627
- Aurora FDRC Inc.
-
Fullerton, California, Yhdysvallat, 92835
- Providence Medical Foundation
-
Montclair, California, Yhdysvallat, 91763
- Catalina Research Institute, LLC
-
Palm Springs, California, Yhdysvallat, 92262
- Desert Oasis Hlthcr Med Group
-
San Dimas, California, Yhdysvallat, 91773
- N America Res Inst - San Dimas
-
-
Connecticut
-
Waterbury, Connecticut, Yhdysvallat, 06708
- Chase Medical Research LLC
-
-
Florida
-
Clearwater, Florida, Yhdysvallat, 33765
- Clinical Res Of W Florida Inc
-
Ocala, Florida, Yhdysvallat, 34470
- Renstar Medical Research
-
Orlando, Florida, Yhdysvallat, 32825
- Florida Institute for Clinical research
-
-
Georgia
-
Albany, Georgia, Yhdysvallat, 31707
- Javara Inc. / Privia Medical Group Georgia LLC
-
Conyers, Georgia, Yhdysvallat, 30094
- Hope Clin Res & Wellness
-
Roswell, Georgia, Yhdysvallat, 30076
- Endocrine Research Solutions, Inc
-
Savannah, Georgia, Yhdysvallat, 31406
- Javara Inc. / Privia Medical Group Georgia LLC
-
-
Illinois
-
Chicago, Illinois, Yhdysvallat, 60640
- Great Lakes Clinical Trials
-
Morton, Illinois, Yhdysvallat, 61550
- Koch Research
-
Skokie, Illinois, Yhdysvallat, 60077
- Evanston Premier Hlthcr Res
-
Skokie, Illinois, Yhdysvallat, 60077
- Endeavor Health
-
Springfield, Illinois, Yhdysvallat, 62702
- SIU Medicine
-
-
Indiana
-
Indianapolis, Indiana, Yhdysvallat, 46260
- Midwest Inst For Clin Res
-
-
Iowa
-
West Des Moines, Iowa, Yhdysvallat, 50266
- Iowa Diabetes Research
-
-
Kentucky
-
Bowling Green, Kentucky, Yhdysvallat, 42101
- Graves Gibert Clinic
-
Louisville, Kentucky, Yhdysvallat, 40213
- Monroe Biomedical Research, LLC
-
-
Michigan
-
Buckley, Michigan, Yhdysvallat, 49620
- Northern Pines Hlth Ctr, PC
-
Flint, Michigan, Yhdysvallat, 48504
- Aa Mrc Llc
-
-
Missouri
-
City of Saint Peters, Missouri, Yhdysvallat, 63303
- StudyMetrix Research LLC
-
St Louis, Missouri, Yhdysvallat, 63128
- Amicis Centers of Clinical Research
-
-
New Hampshire
-
Portsmouth, New Hampshire, Yhdysvallat, 03801
- Seacoast Kidney & Htn Specialists
-
-
New York
-
West Seneca, New York, Yhdysvallat, 14224
- Southgate Medical Group, LLP
-
Westfield, New York, Yhdysvallat, 14787
- Great Lakes Medical Research
-
-
North Carolina
-
Raleigh, North Carolina, Yhdysvallat, 27609
- Medication Management, LLC
-
Raleigh, North Carolina, Yhdysvallat, 27609
- Accellacare_NC
-
Statesville, North Carolina, Yhdysvallat, 28625
- Piedmont Healthcare, Inc.
-
-
Ohio
-
Canton, Ohio, Yhdysvallat, 44718
- Diab & Endo Assoc of Stark Co
-
Wadsworth, Ohio, Yhdysvallat, 44281-9236
- Family Practice Center of Wadsworth Inc.
-
-
Oklahoma
-
Norman, Oklahoma, Yhdysvallat, 73072
- Lynn Institute of Norman
-
-
Rhode Island
-
Cumberland, Rhode Island, Yhdysvallat, 02864
- Clinical Res Collaborative
-
-
South Carolina
-
North Charleston, South Carolina, Yhdysvallat, 29405
- Coastal Carolina Res Ctr
-
Spartanburg, South Carolina, Yhdysvallat, 29303
- Spartanburg Medical Research
-
-
Tennessee
-
Bristol, Tennessee, Yhdysvallat, 37620
- Holston Medical Group Pc
-
Kingsport, Tennessee, Yhdysvallat, 37660
- Holston Medical Group
-
Nashville, Tennessee, Yhdysvallat, 37203
- Clinical Research Associates
-
-
Texas
-
Amarillo, Texas, Yhdysvallat, 79124
- Amarillo Med Spec LLP
-
Austin, Texas, Yhdysvallat, 78731
- Texas Diabetes & Endocrinology
-
Austin, Texas, Yhdysvallat, 78749
- Texas Diabetes & Endocrinology, P.A._Austin
-
Bellaire, Texas, Yhdysvallat, 77401
- Juno Research, LLC
-
Dallas, Texas, Yhdysvallat, 75231
- North Texas Endocrine Center
-
Dallas, Texas, Yhdysvallat, 75226
- Baylor Jack and Jane Hamilton
-
Dallas, Texas, Yhdysvallat, 75230
- Velocity Clin Res, Dallas
-
Houston, Texas, Yhdysvallat, 77079
- The Endocrine Center
-
Houston, Texas, Yhdysvallat, 77036
- Discovery MM Services Inc
-
Lampasas, Texas, Yhdysvallat, 76550
- Radiance Clinical Research
-
Longview, Texas, Yhdysvallat, 75605
- DCOL Ctr for Clin Res
-
San Antonio, Texas, Yhdysvallat, 78212
- Clinical Advancement Center
-
San Antonio, Texas, Yhdysvallat, 78233
- Northeast Clinical Research of San Antonio
-
Shavano Park, Texas, Yhdysvallat, 78231
- Consano Clinical Research, LLC
-
-
Washington
-
Renton, Washington, Yhdysvallat, 98057
- Rainier Clin Res Ctr Inc
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- Resting in-office SBP of 140-160 mmHg (both inclusive) at screening (V1-Optional/V1) and the Run-in visit. Systolic blood pressure will be calculated as the mean of the second and third consecutive readings of triplicated blood pressure readings collected at 2-minute intervals with the blood pressure monitor provided by the Sponsor.
- Body mass index greater than or equal to (>=) 30.0 kilograms per metre square (kg/m^2) at screening.
- Not receiving Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) or antihypertensive medication or on stable (i.e., same drug(s), dose and dosing frequency) SGLT2i or antihypertensive treatment >= 30 days prior to screening.
For participants with Type 2 Diabetes (T2D)
The following inclusion criteria apply at screening in addition to the inclusion criteria listed above:
- Diagnosed with T2D >= 90 days before screening.
- Glycated Haemoglobin (HbA1c) 6.5-10.0% (48-86 millimoles per mole (mmol/mol)) (both inclusive) as measured by the central laboratory at screening.
- Treatment with either lifestyle intervention only, or treatment with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors, glinides, SGLT2i or thiazolidinediones, as a single agent or in combination) according to local label.
- Treatment with antidiabetic medication should be stable (i.e., same drug(s), dose and dosing frequency) for at least 90 days before screening.
Exclusion Criteria:
- Known orthostatic hypotension or orthostatic hypotension at screening (V1-Optional/V1).
- Known secondary hypertension due to renovascular hypertension (renal artery stenosis), primary aldosteronism, Cushing's syndrome, pheochromocytoma, acromegaly, coarctation of the aorta, or any other identifiable cause of secondary hypertension.
- Currently under medical investigation for any cause of secondary hypertension.
- Hospitalisation within the last 90 days before screening for hypertension or hypertensive crisis.
- Atrial fibrillation at the Run-in visit or history of frequent intermittent or chronic atrial fibrillation.
- Moderate-to-severe anaemia with Hgb lesser than (<) 10.9 grams per decilitre (g/dL) as measured by the central lab at screening.
- A change in body weight greater than (>) 5% within 90 days before screening irrespective of medical records.
- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.
- Use of any Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin agonists, within 90 days before screening.
For participants without T2D
- HbA1c greater than or equal to >= 6.5 % (48 mmol/mol) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: CagriSema
Participants will receive CagriSema subcutaneously once weekly. |
CagriSema will be administered subcutaneously. |
|
Active Comparator: Semaglutide
Participants will receive semaglutide subcutaneously once weekly. |
Semaglutide will be administered subcutaneously. |
|
Active Comparator: Cagrilintide
Participants will receive cagrilintide subcutaneously once weekly. |
Cagrilintide will be administered subcutaneously. |
|
Placebo Comparator: Placebo
Participants will receive placebo subcutaneously once weekly. |
Placebo will be administered subcutaneously. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP)
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in millimeters of mercury (mmHg). |
From baseline (week 0) to week 32
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
CagriSema versus Semaglutide and Cagrilintide : Change in in-office systolic blood pressure
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in mmHg. |
From baseline (week 0) to week 32
|
|
Change in Home blood pressure monitoring (HBPM) -based systolic blood pressure
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in mmHg. |
From baseline (week 0) to week 32
|
|
Number of participants who achieve a target goal of in-office systolic blood pressure lesser than or equal to (≤) 130 mmHg
Aikaikkuna: At Week 32
|
Measured as Count of participants. |
At Week 32
|
|
Number of participants who achieve American College of Cardiology and the American Heart Association (ACC/AHA) guidelines based blood pressure targets lesser than (<) 130/80 mmHg
Aikaikkuna: At Week 32
|
Measured as Count of participants. |
At Week 32
|
|
Change in body weight (%)
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in percentage (%). |
From baseline (week 0) to week 32
|
|
Change in body weight (Kg)
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in Kilograms (kg). |
From baseline (week 0) to week 32
|
|
Change in waist circumference
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in centimetre (cm). |
From baseline (week 0) to week 32
|
|
Change in ACC/AHA 10-year atherosclerotic cardiovascular disease (ASCVD) risk score
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in percentage of risk. ACC/AHA risk estimator calculates 10 year risk of ASCVD using a formula which includes age, sex, race, total cholesterol, high density lipoprotein (HDL) cholesterol, systolic blood pressure, blood pressure medication use, diabetes status, smoking status; minimum score 0, maximum score 100 where higher score indicates higher risk of 10-year risk of ASCVD. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Total cholesterol
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: HDL cholesterol
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Low Density Lipoprotein (LDL) cholesterol
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Very Low Density Lipoprotein (VLDL) cholesterol
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Non-HDL cholesterol
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Triglycerides
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of high-sensitivity C-reactive protein (hsCRP)
Aikaikkuna: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- NN9838-8768
- U1111-1338-1943 (Muu tunniste: World Health Organization (WHO))
- 2026-526360-21 (Muu tunniste: European Medical Agency (EMA))
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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