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NCT05968430Active, not recruitingPhase 3

Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension

An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1076 (actual)
First submitted
14 Jul 2023
Start date
14 Jul 2023
Primary completion date
30 Dec 2025
Lead sponsor
Mineralys Therapeutics Inc.
NCT number
NCT05968430
EU CT number
2023-506425-12-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1076
  • From 14 Jul 2023 to the primary completion date, 30 Dec 2025
  • 217 sites in 13 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.

Prior treatment

  • Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol
  • Non-compliance with study medication(s) (defined as taking \<75% or \>125% of the study drug provided) during the first 12 weeks of MLS-101-901

Other illness

  • In the opinion of the Investigator, any condition that will preclude participation in the study
    • \[Randomized treatment withdrawal substudy only\]

Other

  • Women who are pregnant, plan to become pregnant, or are breast-feeding

Who the study is looking for

  • Written informed consent signed by the participant, obtained before any study-related assessment is performed
  • At least 18 years of age at the time of signing the informed consent form (ICF)
  • Completed the EoT or EoS Visit (as applicable) in a lorundrostat study with the option of transitioning to the OLE study, in accordance with the parent study protocol
  • Fertile male subjects and female subjects of childbearing potential, and their partners, must agree to use an acceptable method of contraception from study entry to 28 days after the last dose of study drug
  • Willing and able to comply with the study instructions and attend all scheduled study visits
    • \[Randomized treatment withdrawal substudy only\]
  • Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed

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

Full criteria on ClinicalTrials.gov

Sites (217)

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

SiteCityCountrySite status
Castle Hill Medical Centre
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Castle HillAustraliaUnknown status
Renal Research Gosford
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GosfordAustraliaUnknown status
The University of Western Australia - School of Medicine and Pharmacology - Royal Perth Hospital Unit.
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PerthAustraliaUnknown status
University of Sunshine Coast Clinical Trial Centre
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Sippy DownsAustraliaUnknown status
AusTrials - Taringa
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TaringaAustraliaUnknown status
Medical Center New Polyclinic Gabrovo Ltd.
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GabrovoBulgariaCompleted
Medical Center Exacta Medica OOD
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PlevenBulgariaCompleted
ASOMHIDC - Individual practice "Cardio Tonus" EOOD
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SofiaBulgariaCompleted
Medical Center Hera EOOD
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SofiyaBulgariaCompleted
Medical Center Medicabilis Ltd.
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SofiyaBulgariaCompleted
Medical Center Zara-Med EOOD
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Stara ZagoraBulgariaCompleted
Diagnostic And Consulting Center 1 Veliko Tarnovo Ltd.
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Veliko TirnovoBulgariaCompleted
Centre Medical L'Acadie - Montreal
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MontrealCanadaUnknown status
Emovis GmbH
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BerlinGermanyCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Medizinisches Versorgungszentrum Jung GbR
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DeggingenGermanyCompleted
Klinische Forschung Dresden GmbH
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DresdenGermanyCompleted
Klinische Forschung Hannover-Mitte GmbH
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HanoverGermanyCompleted
Klinische Forschung Karlsruhe GmbH
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KarlsruheGermanyCompleted
Universitaetsklinikum Leipzig Aor
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LeipzigGermanyCompleted
Herzzentrum Leipzig GmbH
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LeipzigGermanyCompleted
PSHI Praxis GmbH
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MainzGermanyCompleted
Kidney Center Wiesbaden-Rheumatology
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WiesbadenGermanyCompleted
Servicio Extremeño de Salud - COMPLEJO HOSPITALARIO UNIVERSITARIO DE BADAJOZ (CHUB)
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BadajozSpainCompleted
Consorci Mar Parc De Salut De Barcelona
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BarcelonaSpainCompleted
Hospital Universitario Reina Sofia
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CórdobaSpainCompleted
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 Fundación Jiménez Díaz
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MadridSpainCompleted
Universidade De Santiago De Compostela
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Santiago De CompostelaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Hospital Universitario Rio Hortega
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ValladolidSpainCompleted
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceCompleted
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceCompleted
Centre Hospitalier Annecy Genevois
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Pringy CedexFranceCompleted
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceCompleted
Cambridge University Hospitals NHS Foundation Trust
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CambridgeUnited KingdomUnknown status
Epsom and St Helier University Hospitals NHS Trust
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CarshaltonUnited KingdomUnknown status
Rowden Surgery Rowden Medical Partnership
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ChippenhamUnited KingdomUnknown status
Fowey River Practice
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FoweyUnited KingdomUnknown status
Queen Elizabeth University Hospital
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GlasgowUnited KingdomUnknown status
Barts Health NHS Trust
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LondonUnited KingdomUnknown status
Newquay Health Centre
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NewquayUnited KingdomUnknown status
Knowle House Surgery
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PlymouthUnited KingdomUnknown status
Rame Medical Limited
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TorpointUnited KingdomUnknown status
I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani
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AnconaItalyCompleted
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
University Hospital Of Ferrara
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FerraraItalyCompleted
IRCCS Ospedale Policlinico San Martino
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GenoaItalyCompleted
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
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L'aquilaItalyCompleted
Azienda Ospedaliera Universitaria Gaetano Martino Messina
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MessinaItalyCompleted
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyCompleted
Università degli Studi di Modena e Reggio Emilia
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ModenaItalyCompleted
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyCompleted
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyCompleted
Azienda Ospedaliero Universitaria Pisana
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PisaItalyCompleted
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyCompleted
Irccs San Raffaele Roma S.r.l.
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RomeItalyCompleted
Humanitas Research Hospital
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RozzanoItalyCompleted
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyCompleted
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyCompleted
Amsterdam UMC
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AmsterdamNetherlandsCompleted
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsCompleted
University Hospital Maastricht
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MaastrichtNetherlandsCompleted
Radboud Universitair Medisch Centrum (Radboudumc)
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NijmegenNetherlandsCompleted
Utrecht University
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UtrechtNetherlandsCompleted
Diamond Clinic Sp. z o.o.
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CracowPolandCompleted
Silmedic Sp. z o.o.
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KatowicePolandCompleted
Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W Katowicach
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KatowicePolandCompleted
Futuremeds Sp. z o.o.
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LodzPolandCompleted
Velocity Nova Sp. z o.o.
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LublinPolandCompleted
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
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OlsztynPolandCompleted
FutureMeds Sp. z o.o.
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OlsztynPolandCompleted
Velocity Skierniewice Sp. z o.o.
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SkierniewicePolandCompleted
ETG Neuroscience Sp. z o.o.
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WarsawPolandCompleted
Latin Clinical Trial Center
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San JuanPuerto RicoUnknown status
Centrul Medical Unirea S.R.L.
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BrasovRomaniaCompleted
Spitalul Clinic Colentina Bucuresti
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BucharestRomaniaCompleted
Delta Health Care S.R.L
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BucharestRomaniaCompleted
Angiocare S.R.L.
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Cluj-NapocaRomaniaCompleted
Spitalul Clinic Municipal Filantropia Craiova
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CraiovaRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Bihor
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OradeaRomaniaCompleted
Spitalul Clinic Judetean de Urgenta Targu Mures
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Târgu MureşRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
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TimisoaraRomaniaCompleted
Materna Care S.R.L.
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TimisoaraRomaniaCompleted
Medicali's S.R.L.
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TimisoaraRomaniaCompleted
American Clinical Trials
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AcworthUnited StatesUnknown status
Albany Medical College
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AlbanyUnited StatesUnknown status
Accelerated Enrollment Solutions (AES) - Anderson
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AndersonUnited StatesUnknown status
Triad Internal Medicine
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AsheboroUnited StatesUnknown status
Morehouse School of Medicine
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AtlantaUnited StatesUnknown status
Research Innovations (Elligo Health Research)
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BeavercreekUnited StatesUnknown status
Entertainment Medical Group, Inc
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Beverly HillsUnited StatesUnknown status
Accel Research Sites (ARS) - Birmingham Clinical Research Unit
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BirminghamUnited StatesUnknown status
Elite Clinical Trials
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BlackfootUnited StatesUnknown status
Boston Clinical Trials
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BostonUnited StatesUnknown status
Hendricks Regional Health Medical Group - Lizton Family Medicine
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BrownsburgUnited StatesUnknown status
Coastal Medical
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BrunswickUnited StatesUnknown status
Erie County Medical Center
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BuffaloUnited StatesUnknown status
Burke Internal Medicine
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BurkeUnited StatesUnknown status
Diabetes & Endocrinology Associates of Stark County
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CantonUnited StatesUnknown status
Punzi Medical Center
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CarrolltonUnited StatesUnknown status
Chandler Clinical Trials
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ChandlerUnited StatesUnknown status
Wake Research - Notus Clinical Trials, LLC
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CharlestonUnited StatesUnknown status
Chattanooga Medical Research
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ChattanoogaUnited StatesUnknown status
AES Chicago/Synexus Clinical Research
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ChicagoUnited StatesUnknown status
Eagle Clinical Research
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ChicagoUnited StatesUnknown status
The University of Chicago Medicine
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ChicagoUnited StatesUnknown status
CA Institute of Renal Research, CA
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Chula VistaUnited StatesUnknown status
Intrepid Research
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CincinnatiUnited StatesUnknown status
Cleveland Clinic - Main Campus
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ClevelandUnited StatesUnknown status
AES - Dallas Fort Worth
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DallasUnited StatesUnknown status
-
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DecaturUnited StatesUnknown status
Colorado Kidney (Denver) Nephrology
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DenverUnited StatesUnknown status
David Turbay, MD, PLLC (Elligo Health Research)
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El PasoUnited StatesUnknown status
Willamette Valley Clinical Studies
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EugeneUnited StatesUnknown status
AES Evansville/Synexus Clinical Research
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EvansvilleUnited StatesUnknown status
Amicis Research Center - Vacaville
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FairfieldUnited StatesUnknown status
Healthcare Research Network - Chicago
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FlossmoorUnited StatesUnknown status
G & L Research LLC
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FoleyUnited StatesUnknown status
Arizona Kidney
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GlendaleUnited StatesUnknown status
Amicis Research Center - Granada Hills
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Granada HillsUnited StatesUnknown status
East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location
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GreenvilleUnited StatesUnknown status
Physician's East Endocrinology
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GreenvilleUnited StatesUnknown status
CMR of Greater New Haven
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HamdenUnited StatesUnknown status
ASHA Clinical Research-Munster, LLC
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HammondUnited StatesUnknown status
Healthcare Research Network-Hazelwood
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HazelwoodUnited StatesUnknown status
Synexus Clinical Research US, Inc.
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HendersonUnited StatesUnknown status
Henderson Clinical Trials
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HendersonUnited StatesUnknown status
Indago Research and Health Center
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HialeahUnited StatesUnknown status
Qway Research
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HialeahUnited StatesUnknown status
AMS Cardiology (Elligo)
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HorshamUnited StatesUnknown status
Juno Research, LLC
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HoustonUnited StatesUnknown status
Gulf Coast Clinical Research
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HoustonUnited StatesUnknown status
Synergy Groups Medical - Bissonet Site
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HoustonUnited StatesUnknown status
Marvel Clinical Research 002, LLC
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Huntington BeachUnited StatesUnknown status
Clinical NeuroScience Solutions Inc
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JacksonvilleUnited StatesUnknown status
Clinical Research Consultants (CRC) - Kansas City
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Kansas CityUnited StatesUnknown status
Medical Colleagues of Texas, LLP (Elligo Health Research)
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KatyUnited StatesUnknown status
R & H Clinical Research
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KatyUnited StatesUnknown status
AMR Knoxville
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KnoxvilleUnited StatesUnknown status
University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)
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La JollaUnited StatesUnknown status
Sierra Clinical Research
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Las VegasUnited StatesUnknown status
Oasis Clinical Trials
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Las VegasUnited StatesUnknown status
Georgia Clinical Research, LLC
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LawrencevilleUnited StatesUnknown status
The Research Group of Lexington LLC
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LexingtonUnited StatesUnknown status
Clinical Trials Research (CTR) - Lincoln
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LincolnUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
Academic Medical Research Institute (AMRI) - Los Angeles
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Los AngelesUnited StatesUnknown status
Nephrology Associates of Kentuckiana
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LouisvilleUnited StatesUnknown status
Gamma Medical Research, Inc.
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McAllenUnited StatesUnknown status
Office of Audrey L. Jones, DO
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McAllenUnited StatesUnknown status
Lifedoc Research
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MemphisUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc.
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MemphisUnited StatesUnknown status
Meridian Family Medicine
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MeridianUnited StatesUnknown status
PRX Research - Mesquite
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MesquiteUnited StatesUnknown status
ActiveMed Practices & Research LLC
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MethuenUnited StatesUnknown status
Nuovida Research Center Corp
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MiamiUnited StatesUnknown status
Synergy Groups Medical - Missouri City
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Missouri CityUnited StatesUnknown status
Carteret Medical Group
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Morehead CityUnited StatesUnknown status
Koch Family Medicine, S.C
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MortonUnited StatesUnknown status
Vanderbilt University Medical Center (VUMC)
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NashvilleUnited StatesUnknown status
Centricity Research New Bern Multispecialty
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New BernUnited StatesUnknown status
Alliance for Multispecialty Research, LLC
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New OrleansUnited StatesUnknown status
Columbia University
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New YorkUnited StatesUnknown status
AES New York/Synexus Clinical Research
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New YorkUnited StatesUnknown status
Eastern VA Medical School
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NorfolkUnited StatesUnknown status
Lynn Institute of Norman (LION Research)
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NormanUnited StatesUnknown status
Coastal Carolina Research Center
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North CharlestonUnited StatesUnknown status
Las Vegas Clinical Trials
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North Las VegasUnited StatesUnknown status
Amicis Research Center - Mission Hills
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NorthridgeUnited StatesUnknown status
Amicis Research Center-Northridge
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NorthridgeUnited StatesUnknown status
Northridge Clinical Trials
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NorthridgeUnited StatesUnknown status
Quality Clinical Research
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OmahaUnited StatesUnknown status
Nephrology Associates of Central Florida
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OrlandoUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc.
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OrlandoUnited StatesUnknown status
AES - Orlando
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OrlandoUnited StatesUnknown status
Pasadena Clinical Trials
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PasadenaUnited StatesUnknown status
Alta Pharmaceutical Research Center
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Peachtree CornersUnited StatesUnknown status
Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)
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Pembroke PinesUnited StatesUnknown status
Pines Care Research Center
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Pembroke PinesUnited StatesUnknown status
Hattiesburg Clinic
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PetalUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
AKDHC Medical Research Services, AZ
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PhoenixUnited StatesUnknown status
Preferred Primary Care Physicians
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PittsburghUnited StatesUnknown status
ACRC Trials - Legacy Medical Village
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PlanoUnited StatesUnknown status
ACRC Trials - Legacy Medical Village Location
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PlanoUnited StatesUnknown status
Clinical Investigations of Texas (CIT)
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PlanoUnited StatesUnknown status
Empire Clinical Research
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PomonaUnited StatesUnknown status
Progressive Medical Research
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Port OrangeUnited StatesUnknown status
Renown Regional Medical Center
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RenoUnited StatesUnknown status
Clinical Trials Research (CTR) - Sacramento
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SacramentoUnited StatesUnknown status
The University of Utah
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Salt Lake CityUnited StatesUnknown status
San Antonio ClinicalTrials
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San AntonioUnited StatesUnknown status
Sun Research Institute (SRI) - San Antonio
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San AntonioUnited StatesUnknown status
Discovery Clinical Trials
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San AntonioUnited StatesUnknown status
Triwest Research Associates
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San DiegoUnited StatesUnknown status
Infigo Clinical Research (Mid Florida)
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SanfordUnited StatesUnknown status
San Jose Clinical Trials
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San JoseUnited StatesUnknown status
Northwest Louisiana Nephrology, LLC - Shreveport
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ShreveportUnited StatesUnknown status
Southern Illinois School of Medicine
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SpringfieldUnited StatesUnknown status
Sugar Lakes Family Practice (Elligo Health Research)
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Sugar LandUnited StatesUnknown status
Clinical Research of West Florida Inc
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TampaUnited StatesUnknown status
AES The Villages
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The VillagesUnited StatesUnknown status
Noble Clinical Research
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TucsonUnited StatesUnknown status
Del Sol Research Management, LLC
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TucsonUnited StatesUnknown status
Amicis Research Center - Valencia
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ValenciaUnited StatesUnknown status
Arthritis & Osteoarthritis Center of SW Ohio/ dba STAT Research
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VandaliaUnited StatesUnknown status
Kidney & Hypertension Center - Victorville
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VictorvilleUnited StatesUnknown status
Accelerated Enrollment Solutions (AES) -Vista/Synexus (Radiant Research)
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VistaUnited StatesUnknown status
Blue Coast Research Center (BCRC)
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VistaUnited StatesUnknown status
Velocity Clinical Research
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West JordanUnited StatesUnknown status
Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office)
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West Palm BeachUnited StatesUnknown status
Office of Ramon Mendez
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WoodbridgeUnited StatesUnknown status

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