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NCT06034743CompletedPhase 3

A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
796 (actual)
First submitted
6 Sept 2023
Start date
22 Nov 2023
Primary completion date
21 May 2025
Lead sponsor
AstraZeneca
NCT number
NCT06034743
EU CT number
2023-505499-32-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 796
  • From 22 Nov 2023 to the primary completion date, 21 May 2025
  • 251 sites in 29 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation
  • New York Heart Association functional heart failure class IV at Screening

Lab values

  • Serum sodium level \< 135 mmol/L at Screening

Other

  • Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg
  • Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg
  • Persistent atrial fibrillation

Who the study is looking for

  • Male or female participants must be ≥ 18 years old
  • Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and \< 170 mmHg at Screening
  • Fulfil at least 1 of the following 2 criteria:
    • uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
    • rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
  • Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening
  • Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening
  • Randomisation Criterion:
  • Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at the Baseline Visit

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (251)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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CABAArgentinaUnknown status
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Ciudad de Buenos AiresArgentinaUnknown status
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CórdobaArgentinaUnknown status
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Mar del PlataArgentinaUnknown status
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MendozaArgentinaUnknown status
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RosarioArgentinaUnknown status
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San Miguel de TucumánArgentinaUnknown status
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San NicolásArgentinaUnknown status
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San VicenteArgentinaUnknown status
A.O. Krankenhaus St. Josef Braunau GmbH
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Braunau Am InnAustriaCompleted
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaCompleted
Medical University of Vienna
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ViennaAustriaCompleted
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ClaytonAustraliaUnknown status
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DarlinghurstAustraliaUnknown status
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EppingAustraliaUnknown status
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GeelongAustraliaUnknown status
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LiverpoolAustraliaUnknown status
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New Lambton HeightsAustraliaUnknown status
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PerthAustraliaUnknown status
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WollongongAustraliaUnknown status
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WoolloongabbaAustraliaUnknown status
Onze-Lieve-Vrouwziekenhuis
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AalstBelgiumCompleted
Az Maria Middelares Gent
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GentBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
CHU de Liège
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LiègeBelgiumCompleted
CHU Helora
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MonsBelgiumCompleted
Medical Center Kordis OOD
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PlevenBulgariaCompleted
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
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SofiaBulgariaCompleted
Diagnostic Consultation Center XX-Sofia EOOD
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SofiaBulgariaCompleted
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaCompleted
MHAT "Sveta Anna" AD
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SofiyaBulgariaCompleted
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CambridgeCanadaUnknown status
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ChicoutimiCanadaUnknown status
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EdmontonCanadaUnknown status
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MarkhamCanadaUnknown status
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NewmarketCanadaUnknown status
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North VancouverCanadaUnknown status
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OttawaCanadaUnknown status
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Saint-Jean-sur-RichelieuCanadaUnknown status
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Scarborough VillageCanadaUnknown status
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TorontoCanadaUnknown status
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WaterlooCanadaUnknown status
Innera s.r.o.
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BenešovCzechiaCompleted
MEDICUS SERVICES s.r.o.
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Brandýs nad LabemCzechiaCompleted
Edumed s.r.o.
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BroumovCzechiaCompleted
KardioBusak s.r.o.
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LounyCzechiaCompleted
Fakultni Nemocnice Ostrava
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PorubaCzechiaCompleted
Kardiologicka ambulance s.r.o.
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Pribram VIIICzechiaCompleted
Clinical Trials Service s.r.o.
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Uherské HradištěCzechiaCompleted
Kardiologische Praxis Dr. med. univ. W. Jungmair
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Bad HomburgGermanyCompleted
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
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Bad OeynhausenGermanyCompleted
Medic Trials ST UG (haftungsbeschraenkt)
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BerlinGermanyCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
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DortmundGermanyCompleted
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyCompleted
Zentrum fuer klinische Studien Suedbrandenburg GmbH
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ElsterwerdaGermanyCompleted
HELIOS Klinikum Erfurt GmbH
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ErfurtGermanyCompleted
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyCompleted
Medizentrum Essen Borbeck
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EssenGermanyCompleted
ClinPhenomics CVC GmbH
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Frankfurt am MainGermanyCompleted
Universitaetsklinikum Frankfurt AöR
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Frankfurt Am MainGermanyCompleted
Medizinische Hochschule Hannover
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HanoverGermanyCompleted
Siteworks GmbH
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HanoverGermanyCompleted
Saarland University Hospital
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HomburgGermanyCompleted
Kardiopraxis Schirmer
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KaiserslauternGermanyCompleted
Universitaetsklinikum Leipzig Aor
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LeipzigGermanyCompleted
Sana Kliniken Luebeck GmbH
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LuebeckGermanyCompleted
CRS Clinical Research Services Management GmbH
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MannheimGermanyCompleted
Universitaetsklinikum Giessen und Marburg GmbH
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MarburgGermanyCompleted
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyCompleted
Kardiologische Praxis Dr. med. Ayham Al-Zoebi Wermsdorf
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WermsdorfGermanyCompleted
Aarhus Universitetshospital
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Aarhus NDenmarkCompleted
Region Midtjylland
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HerningDenmarkCompleted
Holbaek Sygehus
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HolbækDenmarkCompleted
Hospital del Mar
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Area Sanitaria De Ferrol
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FerrolSpainCompleted
Hospital Universitario Virgen de las Nieves
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GranadaSpainCompleted
Hospital Clínico San Carlos
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Hospital Universitario Central De Asturias
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OviedoSpainCompleted
Hospital Universitario Virgen De Valme
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SevillaSpainCompleted
Fundacio Assistencial De Mutua De Terrassa Fpc
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TerrassaSpainCompleted
Hopital Avicenne
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Bobigny CedexFranceCompleted
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceCompleted
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 15FranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceCompleted
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
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ToulonFranceCompleted
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceCompleted
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceCompleted
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BollingtonUnited KingdomUnknown status
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BristolUnited KingdomUnknown status
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ChesterfieldUnited KingdomUnknown status
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DundeeUnited KingdomUnknown status
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GlasgowUnited KingdomUnknown status
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HarrowUnited KingdomUnknown status
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HounslowUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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PrescotUnited KingdomUnknown status
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Weston-super-MareUnited KingdomUnknown status
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YateUnited KingdomUnknown status
DRC Kft.
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BalatonfüredHungaryCompleted
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz
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BudapestHungaryCompleted
Studium Egeszseghaz Kft
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KalocsaHungaryCompleted
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryCompleted
Medifarma-98 Kft.
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NyíregyházaHungaryCompleted
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
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NyíregyházaHungaryCompleted
Coromed Smo Kft
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PécsHungaryCompleted
University of Szeged
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SzegedHungaryCompleted
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AshdodIsraelUnknown status
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HaifaIsraelUnknown status
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Petah TikvaIsraelUnknown status
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Ramat GanIsraelUnknown status
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RehovotIsraelUnknown status
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DelhiIndiaUnknown status
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GunturIndiaUnknown status
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KanpurIndiaUnknown status
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KolkataIndiaUnknown status
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MysuruIndiaUnknown status
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New DelhiIndiaUnknown status
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SuratIndiaUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyCompleted
Istituto Auxologico Italiano
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MilanItalyCompleted
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyCompleted
Centro Cardiologico Monzino S.p.A.
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MilanItalyCompleted
Azienda Ospedaliero Universitaria Pisana
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PisaItalyCompleted
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyCompleted
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyCompleted
Università degli Studi di Udine
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UdineItalyCompleted
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Adachi-kuJapanUnknown status
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ChūōkuJapanUnknown status
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KanazawaJapanUnknown status
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Koga-shiJapanUnknown status
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KyotoJapanUnknown status
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NagasakiJapanUnknown status
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OkayamaJapanUnknown status
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OsakaJapanUnknown status
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SapporoJapanUnknown status
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Tsuchiura-shiJapanUnknown status
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Yufu-shiJapanUnknown status
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Bucheon-siSouth KoreaUnknown status
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BusanSouth KoreaUnknown status
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DaejeonSouth KoreaUnknown status
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IncheonSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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KajangMalaysiaUnknown status
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Kota BharuMalaysiaUnknown status
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KuchingMalaysiaUnknown status
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MalaccaMalaysiaUnknown status
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Muar townMalaysiaUnknown status
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Sarawak MiriMalaysiaUnknown status
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Seri ManjungMalaysiaUnknown status
Academisch Medisch Centrum
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AmsterdamNetherlandsCompleted
Stichting Treant Ziekenhuiszorg
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HoogeveenNetherlandsCompleted
Stichting Radboud University Medical Center
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NijmegenNetherlandsCompleted
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsCompleted
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandCompleted
Centrum Kardiologii Pawel Grzelakowski
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BydgoszczPolandCompleted
American Heart of Poland S.A.
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ChrzanówPolandCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Pratia S.A.
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GdyniaPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
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KrakowPolandCompleted
Nzoz Salusmed
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LodzPolandCompleted
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandCompleted
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
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WarsawPolandCompleted
MTZ Clinical Research powered by Pratia
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WarsawPolandCompleted
Gabinety lekarskie “profesorkarcz.pl”
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WarszawaPolandCompleted
Danderyds Sjukhus AB
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DanderydSwedenCompleted
Sahlgrenska University Hospital-Vastra Gotalandsregionen
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GoteborgSwedenCompleted
Uppsala University Hospital
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UppsalaSwedenCompleted
Nemocnica s poliklinikou Brezno, n.o.
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BreznoSlovakiaCompleted
Cardio D&R s.r.o. Kosice
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KošiceSlovakiaCompleted
MEDI M&M, s.r.o.
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Moldava nad BodvouSlovakiaCompleted
MEDISPOL s.r.o.
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PrešovSlovakiaCompleted
DUAL Medicine s.r.o.
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Rimavska SobotaSlovakiaCompleted
Interna SK s.r.o.
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SvidníkSlovakiaCompleted
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BangkokThailandUnknown status
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BethlehemUnited StatesUnknown status
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BrownsvilleUnited StatesUnknown status
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Chapel HillUnited StatesUnknown status
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ClearwaterUnited StatesUnknown status
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DecaturUnited StatesUnknown status
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