A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

Phase

Condition

Stress

Vascular Diseases

Williams Syndrome

Treatment

Baxdrostat/dapagliflozin

Placebo/dapagliflozin

Clinical Study ID

NCT06742723

D6972C00002

2023-506460-14-00

Ages > 18
All Genders

Study Summary

International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants of any sex and gender must be ≥ 18 years of age at the time of signingthe informed consent.
Participants with (a) or (b): a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND:

UACR ≥ 30 mg/g (3.39 mg/mmol) and < 500 mg/g (56.5 mg/mmol) (central laboratoryvalue only), or
UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or centrallaboratory value), or
UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratoryvalue only). (b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND:
UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local orcentral laboratory value), or
UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratoryvalue only)

[obsolete]
Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at theRandomisation Visit.
Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4weeks prior to Screening Visit.
Participants with:
Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values)
Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2 (local or central laboratory values)

Exclusion

Exclusion Criteria:

Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening.
Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months atscreening.
Serum sodium < 135 mmol/L (central or local laboratory values obtained within 4weeks prior to screening or at the Screening Visit).
Participants with T1DM will be excluded, except:
For US only: patients with T1DM treated with SGLT2i for at least 4 months, withoutDKA during that period, and who have experience with ketone monitoring are eligiblefor inclusion.
For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4months, without DKA during the period of dapagliflozin treatment are eligible forinclusion.

5 Uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) (central or local laboratoryvalues obtained within 3 months prior to screening or at the Screening Visit).

6 New York Heart Association functional HF class IV at screening.

7 Stroke, transient ischaemic cerebral attack, valve implantation or valvereplacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, orhospitalisation for worsening heart failure within previous 3 months prior torandomisation.

8 Documented history of adrenal insufficiency.

9 Any dialysis (including for acute kidney injury) within 3 months prior toScreening Visit.

10 Any acute kidney injury within 3 months prior to the Screening Visit.

11 History of organ transplant or bone marrow transplant, or planned organtransplant within 6 months following randomisation (including kidney transplant).

12 Any clinical condition requiring systemic immunosuppression therapy other thanmaintenance therapy (stable for at least 3 months prior to Visit 1).

Study Design

Baxdrostat/dapagliflozin

March 03, 2025

December 18, 2029

Study Description

The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, HF events, or CV death in participants with CKD and HTN.

This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin.

Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months.

The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred (N = 845) ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within 6 weeks of the PACD. This period can be extended by AstraZeneca.

In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. Baxdrostat/placebo should not be administered without dapagliflozin: baxdrostat/placebo should be interrupted if dapagliflozin is interrupted (baxdrostat/placebo may be resumed with dapagliflozin, if dapagliflozin is resumed), and should be permanently discontinued if dapagliflozin is permanently discontinued. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

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Cali, 760042
Colombia
Active - Recruiting
Research Site
Cali 3687925, 760042
Colombia
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Medellin, 050030
Colombia
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Medellín, 050034
Colombia
Active - Recruiting
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Medellín 3674962, 050030
Colombia
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Monteria, 230002
Colombia
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Montería, 230002
Colombia
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Montería 3674453, 230002
Colombia
Site Not Available
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Pasto, 520002
Colombia
Active - Recruiting
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Pasto 3672778, 520002
Colombia
Site Not Available
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Santiago de Cali 3687925, 760042
Colombia
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Brandys nad Labem, 250 01
Czechia
Site Not Available
Research Site
Brandýs nad Labem, 250 01
Czechia
Suspended
Research Site
Brandýs nad Labem 3078838, 250 01
Czechia
Site Not Available
Research Site
Frýdek-Místek, 738 01
Czechia
Suspended
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Frýdek-Místek 3076127, 738 01
Czechia
Site Not Available
Research Site
Jilemnice, 514 01
Czechia
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Jilemnice 3074187, 514 01
Czechia
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Krnov, 794 01
Czechia
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Krnov 3072656, 794 01
Czechia
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Mladá Boleslav, 293 01
Czechia
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Mladá Boleslav 3070544, 293 01
Czechia
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Nachod, 547 01
Czechia
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Náchod, 547 01
Czechia
Active - Recruiting
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Náchod 3070122, 547 01
Czechia
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Olomouc, 772 00
Czechia
Suspended
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Olomouc 3069011, 772 00
Czechia
Site Not Available
Research Site
Pilsen, 323 00
Czechia
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Pilsen 3068160, 323 00
Czechia
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Plzeň, 323 00
Czechia
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Prague, 140 00
Czechia
Active - Recruiting
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Prague 3067696, 140 00
Czechia
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Praha, 140 21
Czechia
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Praha 10, 104 00
Czechia
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Praha 4, 140 21
Czechia
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Praha 6, 160 00
Czechia
Site Not Available
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Slany, 274 01
Czechia
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Slaný, 274 01
Czechia
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Slaný 3065903, 274 01
Czechia
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Aalborg, 9000
Denmark
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Aalborg 2624886, 9000
Denmark
Site Not Available
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Aarhus, 8200
Denmark
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Aarhus 2624652, 8200
Denmark
Site Not Available
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Copenhagen E, 2100
Denmark
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Herlev, 2730
Denmark
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Herlev 2620431, 2730
Denmark
Site Not Available
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Herning, 7400
Denmark
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Herning 2620425, 7400
Denmark
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Holbæk, 4300
Denmark
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Holbæk 2620147, 4300
Denmark
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Kolding, 6000
Denmark
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Kolding 2618528, 6000
Denmark
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Alexandria, 21131
Egypt
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Alexandria 361058, 21131
Egypt
Site Not Available
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Cairo, 11734
Egypt
Site Not Available
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Cairo 360630, 11734
Egypt
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Dakahlia, 35516
Egypt
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Amiens, 80054
France
Active - Recruiting
Research Site
Amiens 3037854, 80054
France
Site Not Available
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Amiens Cedex 1, 80054
France
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BREST cedex, 29200
France
Site Not Available
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Bordeaux, 33076
France
Active - Recruiting
Research Site
Bordeaux 3031582, 33076
France
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Bordeaux cedex, 33076
France
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Boulogne-Billancourt, 92104
France
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Boulogne-Billancourt 3031137, 92104
France
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Brest, 29200
France
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Brest 3030300, 29200
France
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Clermont-Ferrand, 63003
France
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Clermont-Ferrand 3024635, 63003
France
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Creteil, 94000
France
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Créteil, 94000
France
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Créteil 3022530, 94000
France
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La Roche Sur Yon, 85925
France
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La Roche-sur-Yon, 85925
France
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La Roche-sur-Yon 3006767, 85925
France
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Le Mans, 72037
France
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Le Mans 3003603, 72037
France
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Limoges, 87042
France
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Limoges 2998286, 87042
France
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Lyon, 69437
France
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Lyon 2996944, 69437
France
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Lyon Cedex 03, 69437
France
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Marseille, 13005
France
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Marseille 2995469, 13005
France
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Marseille cedex 6, 13291
France
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Nantes, 44093
France
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Nantes 2990969, 44093
France
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Nantes cedex 1, 44093
France
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Nice, 06000
France
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Nice 2990440, 06000
France
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Nimes, 30000
France
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Nîmes, 30000
France
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Nîmes 2990363, 30000
France
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Paris, 75018
France
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Paris 2988507, 75015
France
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Pierre Bénite, 69495
France
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Pierre-Bénite, 69495
France
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Pierre-Bénite 2987314, 69495
France
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Poitiers, 86021
France
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Poitiers 2986495, 86021
France
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Quimper, 29000
France
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Quimper 2984701, 29000
France
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Reims, 51100
France
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Reims 2984114, 51100
France
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Rouen, 76031
France
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Rouen 2982652, 76031
France
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Saint-Priest-en-Jarez, 42270
France
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Saint-Priest-en-Jarez 2977350, 42270
France
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Strasbourg, 67098
France
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Strasbourg 2973783, 67098
France
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Tours, 37044
France
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Tours 2972191, 37044
France
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Vandoeuvre-Les-Nancy, 54511
France
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Vandœuvre-lès-Nancy, 54511
France
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Vandœuvre-lès-Nancy 2970797, 54511
France
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Bad Homburg, 61348
Germany
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Bad Homburg 2953436, 61348
Germany
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Bamberg, 96049
Germany
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Bamberg 2952984, 96049
Germany
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Berlin, 13509
Germany
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Berlin 2950159, 10629
Germany
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Bochum, 44787
Germany
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Bochum 2947416, 44787
Germany
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Brandenburg, 14776
Germany
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Brandenburg 2945358, 14776
Germany
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Brandenburg an der Havel, 14776
Germany
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Dresden, 01279
Germany
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Dresden 2935022, 01279
Germany
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Essen, 45122
Germany
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Essen 2928810, 45122
Germany
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Friedrichsthal, 66299
Germany
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Friedrichsthal 2924461, 66299
Germany
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Goettingen, 37075
Germany
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Görlitz, 02828
Germany
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Görlitz 2918987, 02828
Germany
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Göttingen, 37075
Germany
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Göttingen 2918632, 37075
Germany
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Hamburg, 21109
Germany
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Hamburg 2911298, 21109
Germany
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Hannover, 30625
Germany
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Hanover, 30625
Germany
Active - Recruiting
Research Site
Hanover 2910831, 30459
Germany
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Heidelberg, 69115
Germany
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Heidelberg 2907911, 69120
Germany
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Herne, 44625
Germany
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Herne 2905891, 44625
Germany
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Karlsburg, 17495
Germany
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Karlsburg 2892887, 17495
Germany
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Karlsruhe, 76133
Germany
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Karlsruhe 2892794, 76137
Germany
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Landshut, 84034
Germany
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Landshut 2881485, 84034
Germany
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Mainz, 55131
Germany
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Mainz 2874225, 55131
Germany
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Obertshausen, 63179
Germany
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Obertshausen 2858763, 63179
Germany
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Offenbach, 63065
Germany
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Offenbach 2857807, 63065
Germany
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Offenbach am Main, 63065
Germany
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Potsdam, 14473
Germany
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Potsdam 2852458, 14473
Germany
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Reinfeld (Holstein), 23858
Germany
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Reinfeld (Holstein) 2848811, 23858
Germany
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Rostock, 18057
Germany
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Rostock 2844588, 18057
Germany
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Rotenburg (Wümme), 27356
Germany
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Rotenburg (Wümme) 2844437, 27356
Germany
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Stuttgart, 70376
Germany
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Stuttgart 2825297, 70376
Germany
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Ulm, 89081
Germany
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Ulm 2820256, 89081
Germany
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Wermsdorf, 04779
Germany
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Wermsdorf 2810848, 04779
Germany
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Zwenkau, 04442
Germany
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Zwenkau 2803588, 04442
Germany
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Alexandroupoli, 68100
Greece
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Alexandroupoli 736928, 68100
Greece
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Alexandroupolis, 68100
Greece
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Athens, 11527
Greece
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Athens 264371, 11527
Greece
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Heraclion, 71500
Greece
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Heraklion, 71500
Greece
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Heraklion 261745, 71500
Greece
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Ioannina, 45500
Greece
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Ioannina 261779, 45500
Greece
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Patras, 26504
Greece
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Pátrai, 26504
Greece
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Pátrai 255683, 26504
Greece
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Thessaloniki, 57010
Greece
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Thessaloniki 734077, 54636
Greece
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Budapest, 1036
Hungary
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Budapest 3054643, 1132
Hungary
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Dunaujvaros, 2400
Hungary
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Dunaújváros, 2400
Hungary
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Dunaújváros 3053438, 2400
Hungary
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Encs, 3860
Hungary
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Encs 721159, 3860
Hungary
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Győr, 9024
Hungary
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Győr 3052009, 9024
Hungary
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Kaposvár, 7400
Hungary
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Kaposvár 3050616, 7400
Hungary
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Nyiregyhaza, 4405
Hungary
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Nyíregyháza, 4400
Hungary
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Nyíregyháza 716935, 4400
Hungary
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Szeged, 6725
Hungary
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Szeged 715429, 6724
Hungary
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Szolnok, 5004
Hungary
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Szolnok 715126, 5004
Hungary
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Székesfehérvár, 8000
Hungary
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Székesfehérvár 3044774, 8000
Hungary
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Zalaegerszeg, 8900
Hungary
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Zalaegerszeg 3042638, 8900
Hungary
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Bangalore, 560060
India
Suspended
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Bangalore 1277333, 560060
India
Site Not Available
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Belagavi, 590010
India
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Belagavi 1276533, 590010
India
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Hyderabad, 500082
India
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Hyderabad 1269843, 500 034
India
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Kolkata, 700014
India
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Kolkata 1275004, 700020
India
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Lucknow, 226010
India
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Madurai, 625107
India
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Madurai 1264521, 625107
India
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Mumbai, 400026
India
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Mumbai 1275339, 400026
India
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New Delhi, 110001
India
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New Delhi 1261481, 110029
India
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Pune, 411013
India
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Pune 1259229, 411013
India
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Vijayawada, 522002
India
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Vijayawada 1253184, 522002
India
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Afula, 18101
Israel
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Afula 295740, 18101
Israel
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Ashdod, 7747629
Israel
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Ashdod 295629, 7747629
Israel
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Be'er Ya'akov, 70300
Israel
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Be’er Ya‘aqov, 70300
Israel
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Be’er Ya‘aqov 295525, 70300
Israel
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Haifa, 34362
Israel
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Haifa 294801, 34362
Israel
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Jerusalem, 91120
Israel
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Jerusalem 281184, 91120
Israel
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Kfar Saba, 44281
Israel
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Kfar Saba 294514, 44281
Israel
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Kfar-Saba, 44281
Israel
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Nahariya, 22100
Israel
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Nahariya 294117, 22100
Israel
Site Not Available
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Petah Tikva, 49372
Israel
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Petah Tikva 293918, 49372
Israel
Site Not Available
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Rehovot, 76100
Israel
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Rehovot 293725, 76100
Israel
Site Not Available
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Tel Aviv, 6423906
Israel
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Tel Aviv 293397, 6423906
Israel
Site Not Available
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Tiberias, 15208
Israel
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Tiberias 293322, 15208
Israel
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Research Site
Bassano del Grappa, 36031
Italy
Active - Recruiting
Research Site
Bassano del Grappa 3182297, 36031
Italy
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Bologna, 40138
Italy
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Bologna 3181928, 40138
Italy
Site Not Available
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Desio, 20832
Italy
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Desio 3177608, 20832
Italy
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Foggia, 71100
Italy
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Foggia 3176885, 71100
Italy
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Genoa, 16132
Italy
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Genoa 3176219, 16132
Italy
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Modena, 41124
Italy
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Modena 3173331, 41124
Italy
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Naples, 80138
Italy
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Napoli, 80138
Italy
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Napoli 9031661, 80138
Italy
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Novara, 28100
Italy
Active - Recruiting
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Novara 3172189, 28100
Italy
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Padova, 35128
Italy
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Padua, 35128
Italy
Active - Recruiting
Research Site
Padua 3171728, 35128
Italy
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Pavia, 27100
Italy
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Pavia 3171366, 27100
Italy
Site Not Available
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Pisa, 56124
Italy
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Pisa 3170647, 56124
Italy
Site Not Available
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Pordenone, 33170
Italy
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Research Site
Pordenone 3170147, 33170
Italy
Site Not Available
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Roma, 00168
Italy
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Research Site
Roma 8957247, 00168
Italy
Site Not Available
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Rozzano, 20089
Italy
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Research Site
Rozzano 3168837, 20089
Italy
Site Not Available
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Torino, 10126
Italy
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Research Site
Torino 8980539, 10126
Italy
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Tradate, 21049
Italy
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Tradate 3165340, 21049
Italy
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Aira, 899-5421
Japan
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Research Site
Aira 11611646, 899-5421
Japan
Site Not Available
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Aira-City, 899-5421
Japan
Site Not Available
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Amagasaki-shi, 660-8550
Japan
Active - Recruiting
Research Site
Beppu-shi, 874-0011
Japan
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Research Site
Chigasaki-shi, 253-0044
Japan
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Fujinomiya-shi, 418-0076
Japan
Site Not Available
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Hakodate-shi, 041-8680
Japan
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Hamamatsu, 432-8580
Japan
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Hamamatsu 1863289, 432-8580
Japan
Site Not Available
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Hamamatsu-shi, 432-8580
Japan
Site Not Available
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Higashihiroshima-shi, 739-0041
Japan
Active - Recruiting
Research Site
Iizuka-shi, 820-8505
Japan
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Research Site
Inashiki-gun, 300-0395
Japan
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Research Site
Itabashi-ku, 173-0015
Japan
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Iwata-shi, 438-8550
Japan
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Research Site
Kagoshima, 890-0073
Japan
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Kagoshima 1860827, 890-0073
Japan
Site Not Available
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Kamakura-shi, 247-0056
Japan
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Kanazawa, 920-8530
Japan
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Kanazawa 1860243, 920-8530
Japan
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Kanazawa-shi, 920-8530
Japan
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Kashiwara-shi, 582-0005
Japan
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Kasugai-shi, 486-8510
Japan
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Kita-ku, 144-0001
Japan
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Kita-ku 8469285, 144-0001
Japan
Site Not Available
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Kitakyushu, 802-8555
Japan
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Kitakyushu 1859307, 802-8555
Japan
Site Not Available
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Kitakyushu-shi, 807-0857
Japan
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Kobe, 650-0047
Japan
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Kobe 1859171, 650-0047
Japan
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Kobe-shi, 650-0047
Japan
Site Not Available
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Kumagaya-shi, 360-0197
Japan
Active - Recruiting
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Kurashiki Shi, 701 0192
Japan
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Kuse-gun, 613-0034
Japan
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Kuwana-shi, 511-0061
Japan
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Kyoto, 604-8845
Japan
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Kyoto 1857910, 604-8845
Japan
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Kyoto-shi, 604-8845
Japan
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Matsusaka-shi, 515-8557
Japan
Active - Recruiting
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Matsuyama, 790-8524
Japan
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Matsuyama 1926099, 790-0024
Japan
Site Not Available
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Matsuyama-city, 790-0024
Japan
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Meguro-ku, 153-0051
Japan
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Minato-ku, 108-0073
Japan
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Minatoku, 105-8471
Japan
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Minatoku 11191118, 105-8471
Japan
Site Not Available
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Minokamo Shi, 505-8510
Japan
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Miyakonojo-shi, 885-0035
Japan
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Morioka, 020-0066
Japan
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Morioka 2111834, 020-0066
Japan
Site Not Available
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Morioka-shi, 020-0066
Japan
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Nagaoka-shi, 940-8621
Japan
Active - Recruiting
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Naka, 311-0113
Japan
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Naka 2111749, 311-0113
Japan
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Japan
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Hanoi, 10000
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A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

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