Trial Condition(s):

Heart Failure

Phase IIb safety and efficacy study of different oral doses of BAY94-8862 in subjects with worsening chronic heart failure and left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or chronic kidney disease alone (ARTS-HF)

Bayer Identifier:

14564

ClinicalTrials.gov Identifier:

NCT01807221

EudraCT Number:

2012-002627-15

Study Completed

Trial Purpose

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

Inclusion Criteria
- Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country
- Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
 - Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
 - Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV
 - Subjects with type 2 diabetes mellitus 
and / or
 - Subjects with 30 mL/min/1.73m^2 </= eGFR </= 60 mL/min/1.73m^2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening 
 - Left ventricular ejection fraction (LVEF) </= 40%
 - Blood potassium </= 5.0 mmol/L at screening 
 - Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the screening visit
Exclusion Criteria
- Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
 - Acute coronary syndrome (ACS) in last 30 days prior to screening
 - Cardiogenic shock
 - Valvular heart disease requiring surgical intervention during the course of the study
 - Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
 - Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic

Trial Summary

Enrollment Goal
1066
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
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Locations

Investigative Site

Espoo, Finland, 02740

Status
Completed
 
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Helsinki, Finland, 00099

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Completed
 
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Turku, Finland, 20520

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Completed
 
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Rovaniemi, Finland, 96101

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Completed
 
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Rouen, France, 76031

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Completed
 
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TOULOUSE, France, 31403

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Completed
 
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Paris cedex 13, France, 75013

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Completed
 
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Bron, France, 69677

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Completed
 
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PARIS cedex 10, France, 75475

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Completed
 
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Vandoeuvre les Nancy, France, 54500

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Completed
 
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Hannover, Germany, 30625

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Completed
 
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Berlin, Germany, 13353

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Completed
 
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Homburg, Germany, 66421

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Completed
 
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Mönchengladbach, Germany, 41063

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Completed
 
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Erfurt, Germany, 99089

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Vilnius, Lithuania, LT-08661

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Kaunas, Lithuania, LT-50161

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Kaunas, Lithuania, LT-44320

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Kaunas, Lithuania, LT-47144

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Klaipeda, Lithuania, LT-92288

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Klaipeda, Lithuania, 92288

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Chaidari, Greece, 12462

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Athens, Greece, 11526

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Athens, Greece, 11527

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Göttingen, Germany, 37099

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Completed
 
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Copenhagen Ø, Denmark, 2100

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Completed
 
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Hellerup, Denmark, 2900

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Completed
 
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København NV, Denmark, 2400

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Completed
 
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Hvidovre, Denmark, 2650

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Herlev, Denmark, 2730

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Svendborg, Denmark, 5700

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Completed
 
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Køge, Denmark, 4600

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Viborg, Denmark, 8800

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Bergamo, Italy, 24127

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Monza Brianza, Italy, 20900

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Milano, Italy, 20149

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Foggia, Italy, 71100

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Roma, Italy, 00163

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Arezzo, Italy, 52044

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Würzburg, Germany, 97078

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Bad Oeynhausen, Germany, 32545

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Stavanger, Norway, 4011

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Wien, Austria, 1100

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Salzburg, Austria, 5020

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Krems an der Donau, Austria, 3500

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Linz, Austria, 4010

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El Palmar, Spain, 30120

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Göteborg, Sweden, 416 85

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Stockholm, Sweden, 118 83

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Stockholm, Sweden, 141 86

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Stockholm, Sweden, 182 88

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Örebro, Sweden, 701 85

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Falun, Sweden, 791 82

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Umeå, Sweden, 901 85

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Pisa, Italy, 56124

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Graz, Austria, 8020

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Graz, Austria, 8036

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Perugia, Italy, 06129

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Completed
 
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Detroit, United States, 48201

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Detroit, United States, 48202

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Completed
 
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Innsbruck, Austria, 6020

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Valencia, Spain, 46010

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Completed
 
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Valencia, Spain, 46026

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Madrid, Spain, 28041

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Barcelona, Spain, 08035

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Toronto, Canada, M5B 1W8

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Sherbrooke, Canada, J1H 5N4

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Ottawa, Canada, K1Y 4W7

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Montreal, Canada, H3T 1E2

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Montreal, Canada, H1T 1C8

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Saint-Jean-sur-Richelieu, Canada, J3A 1C3

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Calgary, Canada, T2N 4Z6

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Esbjerg, Denmark, 6700

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Barcelona, Spain, 08003

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Seoul, South Korea, 05505

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Seoul, South Korea, 03080

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Wonju, South Korea, 26426

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Petoria, South Africa

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Completed
 
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Tongaat, South Africa, 4400

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Merebank, South Africa, 4052

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Somerset West, South Africa, 7130

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Worcester, South Africa, 6850

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Pinelands, South Africa, 7405

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Isipingo Rail, South Africa, 4110

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Kuils River, South Africa, 7580

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Cape Town, South Africa, 7500

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Completed
 
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Zefat, Israel, 1311001

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Completed
 
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Ashkelon, Israel, 7830604

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Completed
 
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Petach Tikva, Israel, 4941492

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Completed
 
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Rehovot, Israel, 7610001

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Completed
 
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Hadera, Israel, 3810101

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Completed
 
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Tel Aviv, Israel, 64239

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Completed
 
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Afula, Israel, 1834111

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Completed
 
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Jerusalem, Israel, 9103102

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Completed
 
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Haifa, Israel, 3436212

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Completed
 
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Nahariya, Israel, 2210001

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Completed
 
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Kfar Saba, Israel, 4428164

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Completed
 
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Zerifin, Israel, 7030000

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Completed
 
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Macon, United States, 31201

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Completed
 
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Olot, Spain, 17800

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Completed
 
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Praha 5, Czech Republic, 150 30

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Completed
 
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Majadahonda, Spain, 28222

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Completed
 
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Szekesfehervar, Hungary, 8000

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Completed
 
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Budapest, Hungary, 1027

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Completed
 
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Budapest, Hungary, 1097

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Completed
 
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Budapest, Hungary, 1085

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Completed
 
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Nagykanizsa, Hungary, 8800

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Completed
 
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Stade, Germany, 21682

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Completed
 
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Ostrava, Czech Republic, 728 80

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Completed
 
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Jindrichuv Hradec, Czech Republic, 377 01

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Completed
 
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Investigative Site

Baltimore, United States, 21201

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Completed
 
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Wroclaw, Poland, 50-981

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Completed
 
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Krakow, Poland, 31-121

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Completed
 
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Bydgoszcz, Poland, 85-681

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Completed
 
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Szczecin, Poland, 70-965

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Completed
 
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Investigative Site

Gdansk, Poland, 80-952

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Completed
 
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Investigative Site

Newark, United States, 07103

Status
Completed
 
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Investigative Site

La Jolla, United States, 92037

Status
Completed
 
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Investigative Site

GRONINGEN, Netherlands, 9700 RB

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Completed
 
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Investigative Site

NIJMEGEN, Netherlands, 6525 GA

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Completed
 
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Investigative Site

GRONINGEN, Netherlands, 9728 NT

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Completed
 
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Investigative Site

VELDHOVEN, Netherlands, 5504 DB

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Completed
 
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Investigative Site

AMSTERDAM, Netherlands, 1061 AE

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Completed
 
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ROTTERDAM, Netherlands, 3045 PM

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Completed
 
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DELFT, Netherlands, 2625 AD

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Completed
 
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HOOGEVEEN, Netherlands, 7909 AA

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Completed
 
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Prahran, Australia, 3004

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Completed
 
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Investigative Site

Adelaide, Australia, 5042

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Completed
 
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Investigative Site

Concord, Australia, 2139

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Completed
 
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Investigative Site

Porto, Portugal, P-4200

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Completed
 
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Investigative Site

Lisboa, Portugal, 1500-650

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Completed
 
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Investigative Site

Almada, Portugal, 2801-951

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Completed
 
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Investigative Site

Lisboa, Portugal, 1449-005

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Completed
 
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Investigative Site

Lisboa, Portugal, 1649-035

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Completed
 
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Investigative Site

Faro, Portugal, 8000-386

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Completed
 
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Investigative Site

Taipei, Taiwan, China, 11217

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Completed
 
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Investigative Site

Taipei, Taiwan, China, 100

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Completed
 
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Taipei, Taiwan, China

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Completed
 
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Investigative Site

Taizung, Taiwan, China, 402

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Completed
 
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Investigative Site

Jacksonville, United States, 32209

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Completed
 
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Investigative Site

Los Angeles, United States, 90033

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Completed
 
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Warszawa, Poland, 04-628

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Completed
 
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Investigative Site

Katowice, Poland, 40-635

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Completed
 
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Kielce, Poland, 25-736

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Completed
 
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Bialystok, Poland, 15-276

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Completed
 
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Investigative Site

ZUTPHEN, Netherlands, 7207 AE

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Completed
 
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Investigative Site

Ruse, Bulgaria, 7002

Status
Completed
 
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Investigative Site

Varna, Bulgaria, 9010

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Completed
 
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Investigative Site

Pazardzhik, Bulgaria, 4400

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Completed
 
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Investigative Site

Sofia, Bulgaria, 1309

Status
Completed
 
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Investigative Site

Sofia, Bulgaria, 1431

Status
Completed
 
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Investigative Site

Sofia, Bulgaria, 1233

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Completed
 
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Investigative Site

Quebec, Canada, G1V 4G5

Status
Completed
 
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Investigative Site

DARLINGHURST, Australia, 2010

Status
Completed
 
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Investigative Site

Burgas, Bulgaria, 8018

Status
Completed
 
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Investigative Site

Nea Ionia / Athens, Greece, 14233

Status
Completed
 
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Investigative Site

Larissa, Greece, 41100

Status
Completed
 
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Investigative Site

Birmingham, United States, 35294-2041

Status
Completed
 
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Investigative Site

Slany, Czech Republic, 274 01

Status
Completed
 
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Investigative Site

NICE, France, 06200

Status
Completed
 
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Investigative Site

Frankfurt, Germany, 60389

Status
Completed
 
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Investigative Site

Seoul, South Korea, 03722

Status
Completed
 
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Investigative Site

New Taipei City, Taiwan, China, 220

Status
Completed
 
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Investigative Site

Ankara, Turkey, 06100

Status
Completed
 
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Ankara, Turkey, 06500

Status
Completed
 
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Investigative Site

Izmir, Turkey, 35100

Status
Completed
 
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Ankara, Turkey

Status
Completed
 
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Investigative Site

Antalya, Turkey, 07003

Status
Completed
 
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Investigative Site

Fairfield, United States, 45014

Status
Completed
 
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Investigative Site

Glostrup, Denmark, 2600

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H2W 1T8

Status
Completed
 
Locations

Investigative Site

Limburg, Germany, 65549

Status
Completed
 

Trial Design