Trial Condition(s):

Atrial fibrillation (AF)

Study to gather information about the proper dosing of the oral FXIa inhibitor BAY 2433334 and to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with irregular heartbeat (atrial fibrillation) that can lead to heart-related complications. (PACIFIC-AF)

Bayer Identifier:

19765

ClinicalTrials.gov Identifier:

NCT04218266

EudraCT Number:

2019-002365-35

EU CT Number:

Not Available

Recruiting

Trial Purpose

The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works in patients with irregular heartbeat (atrial fibrillation) that can lead to blood clots, stroke and other heart-related complications. In addition researchers want to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with atrial fibrillation. This study is also done to learn how the drug in this study moves into, through and out of the body. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.
Apixaban, works by reducing the production of blood clotting factors in our body and thins the blood and is a so called non-vitamin K oral anticoagulant (NOAC). Thinning the blood can prevent you from blood clots which can cause a stroke.

Inclusion Criteria
- Participant must be 45 years of age or older at the time of signing the informed consent.
- Participant with AF documented by ECG evidence with
-- CHA2DS2-VASc score ≥ 2 if male or CHA2DS2-VASc score ≥ 3 if female
-- Indication for treatment with an oral anticoagulant in
--- any participant currently not treated with an oral anticoagulant (e.g. treatment naïve) or alternatively,
--- participant on a NOAC in case of at least one bleeding risk feature (history of a prior bleed within the last 12 months requiring medical attention and / or moderate renal dysfunction with eGFR 30-50 ml/min and / or current clinically indicated antiplatelet therapy with Acetylsalicylic acid(ASA) ≤ 100 mg)
- Written informed consent
Exclusion Criteria
- Mechanical heart valve prosthesis 
- Any degree of rheumatic mitral stenosis or moderate-to-severe, non-rheumatic mitral stenosis
- Atrial fibrillation due to a reversible cause, participants in sinus rhythm after successful ablation, or plan for cardioversion or ablation during study conduct
- Requirement for chronic anticoagulation (for a different indication than AF) or antiplatelet therapy (up to 100 mg ASA is allowed). Anticipated need for chronic therapy with Nonsteroidal anti-inflammatory drugs (NSAIDs)
- Treated with a Vitamin K antagonist in the 30 days prior to screening

Trial Summary

Enrollment Goal
750
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
BAY2433334
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Krajska nemocnice T. Bati, a.s.

Zlin, Czech Republic, 762 75

Status
Not yet recruiting
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Nemocnice Slany

Slany, Czech Republic, 274 01

Status
Recruiting
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Universitätsspital Basel

Basel, Switzerland, 4031

Status
Not yet recruiting
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Inselspital Universitätsspital Bern

Bern, Switzerland, 3010

Status
Not yet recruiting
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Kantonsspital Winterthur

Winterthur, Switzerland, 8401

Status
Not yet recruiting
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Kantonsspital St. Gallen

St. Gallen, Switzerland, 9007

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Not yet recruiting
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Kantonsspital Aarau

Aarau, Switzerland, 5001

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Not yet recruiting
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Luzerner Kantonsspital

Luzern, Switzerland, 6000

Status
Not yet recruiting
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Ospedale regionale di Lugano

Lugano, Switzerland, 6900

Status
Not yet recruiting
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Hôpital Cantonal Universitaire de Genève

Genève, Switzerland, 1211

Status
Not yet recruiting
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Jessa Ziekenhuis

HASSELT, Belgium, 3500

Status
Recruiting
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AZ St-Jan Brugge Oostende AV

BRUGGE, Belgium, 8000

Status
Recruiting
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Imeldaziekenhuis - St-Elisabethkliniek

BONHEIDEN, Belgium, 2820

Status
Not yet recruiting
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UZ Antwerpen

EDEGEM, Belgium, 2650

Status
Not yet recruiting
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VZW Emmaus

MECHELEN, Belgium, 2800

Status
Recruiting
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UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

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Not yet recruiting
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Hospital Arnau de Vilanova de Valencia

Valencia, Spain, 46015

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Not yet recruiting
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Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

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Not yet recruiting
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Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

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Not yet recruiting
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Hospital Virgen de la Victoria

Málaga, Spain, 29010

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Not yet recruiting
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Hospital del Mar

Barcelona, Spain, 08003

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Not yet recruiting
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Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Recruiting
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Hospital Ramón y Cajal

Madrid, Spain, 28034

Status
Not yet recruiting
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Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08041

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Not yet recruiting
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AZ Delta

ROESELARE, Belgium, 8800

Status
Not yet recruiting
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Heart and Chest Hospital

Liverpool, United Kingdom, L14 3PE

Status
Not yet recruiting
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Staploe Medical Centre

Ely, United Kingdom, CB7 5SQ

Status
Not yet recruiting
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Queen Elizabeth II Hospital

Welwyn Garden City, United Kingdom, AL7 4HQ

Status
Not yet recruiting
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Chesterfield Royal Hospital

Chesterfield, United Kingdom, S44 5DX

Status
Not yet recruiting
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Northwick Park Hospital

Harrow, United Kingdom, HA1 3UJ

Status
Not yet recruiting
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University Hospital of Wales

Cardiff, United Kingdom, CF14 4XW

Status
Not yet recruiting
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Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

Budapest, Hungary

Status
Not yet recruiting
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Tolna Megyei Balassa Janos Korhaz

Szekszard, Hungary, 7100

Status
Recruiting
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Dr. Bugyi Istvan Hopsital (Korhaz)

Szentes, Hungary, 6600

Status
Recruiting
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Kanizsai Dorottya Hospital

Nagykanizsa, Hungary, 8800

Status
Not yet recruiting
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University of Semmelweis/ Semmelweis Egyetem

Budapest, Hungary, 1122

Status
Not yet recruiting
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Pecsi Tudomanyegyetem Klinikai Kozpont

Pecs, Hungary, 7624

Status
Recruiting
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Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

Budapest, Hungary, 1134

Status
Not yet recruiting
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Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.

Nyiregyhaza, Hungary, 4400

Status
Recruiting
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Population Health Research Institute

Hamilton, Canada, L8L 0A6

Status
Not yet recruiting
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Clinique Sante Cardio MC

Montreal, Canada, H1T 3Y7

Status
Recruiting
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Royal Alexandra Hospital

Edmonton, Canada, T5H 3V9

Status
Not yet recruiting
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St. Michael's Hospital Health Centre

Toronto, Canada, M5B 1W8

Status
Not yet recruiting
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Cambridge Cardiac Care Center

Cambridge, Canada, N1R 6V6

Status
Not yet recruiting
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Institut universitaire de cardiologie et de pneumologie

Ste-Foy, Canada, G1V 4G5

Status
Not yet recruiting
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Fakultni nemocnice Kralovske Vinohrady

Praha 10, Czech Republic, 100 34

Status
Not yet recruiting
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Institut Klinicke a Experimentalni Mediciny

Praha 4, Czech Republic, 140 21

Status
Not yet recruiting
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Oblastni Nemocnice Kladno

Kladno, Czech Republic, 27259

Status
Not yet recruiting
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Fakultni nemocnice Plzen

Plzen, Czech Republic, 304 60

Status
Not yet recruiting
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Nemocnice Pardubickeho kraje a.s., Orlickoustecka nemocnice

Usti nad Orlici, Czech Republic, 56218

Status
Not yet recruiting
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Fakultni nemocnice v Motole

Praha 5, Czech Republic, 150 06

Status
Recruiting
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Ventspils Hospital

Ventspils, Latvia, LV-3601

Status
Not yet recruiting
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Liepaja Regional Hospital

Liepaja, Latvia, LV-3414

Status
Not yet recruiting
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1st Riga Clinical Hospital

Riga, Latvia, LV-1001

Status
Not yet recruiting
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Clinic of Obstetrics and Gynaecology

Riga, Latvia, LV-1002

Status
Not yet recruiting
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Daugavpils Regional Hospital

Daugavpils, Latvia, LV-5417

Status
Not yet recruiting
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Riga East Clinical University Hospital "Gailezers"

Riga, Latvia, LV-1038

Status
Not yet recruiting
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Doctor's Practice in Cardiology

Daugavpils, Latvia, LV-5401

Status
Recruiting
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AUSL Toscana Sud-Est

Arezzo, Italy, 52100

Status
Not yet recruiting
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AUSL Toscana Sud-Est

Arezzo, Italy, 52040

Status
Not yet recruiting
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A.O. di Perugia

Perugia, Italy, 06132

Status
Not yet recruiting
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ASUR Marche - Area Vasta 5

Ascoli Piceno, Italy, 63074

Status
Not yet recruiting
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IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro

Genova, Italy, 16132

Status
Not yet recruiting
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ASST Spedali Civili

Brescia, Italy, 25123

Status
Not yet recruiting
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A.O. Ospedali Riuniti Villa Sofia-Cervello

Palermo, Italy, 90146

Status
Not yet recruiting
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A.O.U. Policlinico Umberto I

Roma, Italy, 00161

Status
Not yet recruiting
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Krankenhaus St. Josef Braunau

Braunau, Austria, 5280

Status
Not yet recruiting
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Krankenhauses Nord – Klinik Floridsdorf

Wien, Austria, 1210

Status
Not yet recruiting
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Landeskrankenhaus Feldkirch

Feldkirch, Austria, 6807

Status
Not yet recruiting
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Uniklinikum Salzburg - Landeskrankenhaus

Salzburg, Austria, 5020

Status
Not yet recruiting
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Allgemeines Krankenhaus der Stadt Wien

Wien, Austria, 1090

Status
Not yet recruiting
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Medizinische Universität Graz

Graz, Austria, 8036

Status
Not yet recruiting
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Medizinische Universität Innsbruck

Innsbruck, Austria, 6020

Status
Not yet recruiting
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Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria, 4020

Status
Not yet recruiting
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Hôpital Henri Mondor

CRETEIL, France, 94010

Status
Not yet recruiting
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Centre Hospitalier Régional - Saint Brieuc

SAINT BRIEUC, France, 22000

Status
Not yet recruiting
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Centre Hospitalier Départemental Vendée

LA ROCHE SUR YON CEDEX, France, 85025

Status
Not yet recruiting
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Centre Hospitalier Louis Pasteur

LE COUDRAY, France, 28630

Status
Not yet recruiting
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Hopital Bichat - Paris

PARIS, France, 75018

Status
Not yet recruiting
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Centre Hospitalier - Valenciennes Cedex

VALENCIENNES CEDEX, France, 59322

Status
Recruiting
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Hôpital de Rangueil - Toulouse

TOULOUSE, France, 31403

Status
Not yet recruiting
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Hopital de Cardiologie - Lille

LILLE cedex, France, 59037

Status
Not yet recruiting
Locations

Queen Elizabeth II Health Sciences Centre

Halifax, Canada, B3H 3A7

Status
Not yet recruiting
Locations

Montreal Heart Institute

Montreal, Canada, H1T 1C8

Status
Not yet recruiting
Locations

H. Hartziekenhuis Mol

MOL, Belgium, 2400

Status
Not yet recruiting
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SU/Östra

Göteborg, Sweden, 416 85

Status
Not yet recruiting
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Capio Citykliniken Närsjukvården AB

Lund, Sweden, 222 21

Status
Not yet recruiting
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Danderyds sjukhus

Stockholm, Sweden, 182 88

Status
Not yet recruiting
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Avdelningen för kliniska prövningar AKP

Örebro, Sweden, 703 62

Status
Not yet recruiting
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Södersjukhuset AB

Stockholm, Sweden, 118 83

Status
Not yet recruiting
Locations

Skellefteå Lasarett

Skellefteå, Sweden, 931 86

Status
Not yet recruiting
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Falu Lasarett

Falun, Sweden, 791 82

Status
Not yet recruiting
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Östersunds Sjukhus

Östersund, Sweden, 831 83

Status
Not yet recruiting
Locations

Koto Hospital

Koto-ku, Japan, 136-0072

Status
Not yet recruiting
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Kishiwada Tokushukai Hospital

Kishiwada, Japan, 596-0042

Status
Not yet recruiting
Locations

Nishiarai Heart Center Hospital

Adachi-ku, Japan, 123-0845

Status
Not yet recruiting
Locations

Nakamura Cardiovascular Clinic

Itoshima, Japan, 819-1104

Status
Not yet recruiting
Locations

Hyogo Brain and Heart Center

Himeji, Japan, 670-0981

Status
Not yet recruiting
Locations

Tokyo Angel Hospital

Hachioji, Japan, 193-0811

Status
Not yet recruiting
Locations

Okinawa Tokushukai Hayama Heart Center

Miura-gun, Japan, 240-0116

Status
Not yet recruiting
Locations

Yao Tokushukai General Hospital

Yao, Japan, 581-0011

Status
Recruiting
Locations

Minamino Cardiovascular Hospital

Hachioji, Japan, 192-0918

Status
Not yet recruiting
Locations

Academisch Medisch Centrum (AMC)

AMSTERDAM, Netherlands, 1105 AZ

Status
Not yet recruiting
Locations

Maastricht UMC

MAASTRICHT, Netherlands, 6229 HX

Status
Not yet recruiting
Locations

Amphia Ziekenhuis, locatie Molengracht

BREDA, Netherlands, 4818 CK

Status
Not yet recruiting
Locations

Martini Ziekenhuis, Locatie van Swieten

GRONINGEN, Netherlands, 9728 NT

Status
Not yet recruiting
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Ziekenhuis Rijnstate

ARNHEM, Netherlands, 6815 AD

Status
Not yet recruiting
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Spaarne Gasthuis - locatie Zuid

HAARLEM, Netherlands, 2035 RC

Status
Not yet recruiting
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Albert Schweitzer Ziekenhuis, Locatie Dordwijk

DORDRECHT, Netherlands, 3318 AT

Status
Not yet recruiting
Locations

Medisch Spectrum Twente

ENSCHEDE, Netherlands, 7511 JX

Status
Not yet recruiting
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St Richard's Hospital

Chichester, United Kingdom, PO19 6SE

Status
Not yet recruiting

Trial Design