Trial Condition(s):

Heart Failure

Phase IIb safety and efficacy study of four dose regimens of BAY1021189 in patients with heart failure with reduced ejection fraction suffering from worsening chronic heart failure (SOCRATES-REDUCED)

Bayer Identifier:

15371

ClinicalTrials.gov Identifier:

NCT01951625

EudraCT Number:

2013-002287-11

Study Completed

Trial Purpose

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).

Inclusion Criteria
- Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization
- Left ventricular ejection fraction (LVEF) <45% by echocardiography at randomization
Exclusion Criteria
- Intravenous inotropes at any time after hospitalization

Trial Summary

Enrollment Goal
456
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Valencia, Spain, 46026

Status
Completed
 
Locations

Investigative Site

Majadahonda, Spain, 28222

Status
Completed
 
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Investigative Site

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
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Barcelona, Spain, 08023

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08003

Status
Completed
 
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Santander, Spain, 39008

Status
Completed
 
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BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
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Investigative Site

Singapore, Singapore, 169609

Status
Completed
 
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Singapore, Singapore, 308433

Status
Completed
 
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Singapore, Singapore, 768828

Status
Completed
 
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Investigative Site

Singapore, Singapore, 119228

Status
Completed
 
Locations

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München, Germany, 80331

Status
Completed
 
Locations

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Münster, Germany, 48149

Status
Completed
 
Locations

Investigative Site

Frankfurt, Germany, 60596

Status
Completed
 
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Homburg, Germany, 66424

Status
Completed
 
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Erfurt, Germany, 99089

Status
Completed
 
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Köln, Germany, 50924

Status
Completed
 
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Greifswald, Germany, 17475

Status
Completed
 
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Hamburg, Germany, 20246

Status
Completed
 
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Graz, Austria, 8036

Status
Completed
 
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Wien, Austria, 1220

Status
Completed
 
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Salzburg, Austria, 5020

Status
Completed
 
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St. Pölten, Austria, 3100

Status
Completed
 
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Buffalo, United States, 14215

Status
Completed
 
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Atlanta, United States, 30342

Status
Completed
 
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Fountain Valley, United States, 92708

Status
Completed
 
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Milwaukee, United States, 53215

Status
Completed
 
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Sherbrooke, Canada, J1G 2E8

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Completed
 
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Toronto, Canada, M5B 1W8

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Completed
 
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Quebec, Canada, G1V 4G5

Status
Completed
 
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DEVENTER, Netherlands, 7416 SE

Status
Completed
 
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LEEUWARDEN, Netherlands, 8901 BR

Status
Completed
 
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Szekesfehervar, Hungary, 8000

Status
Completed
 
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Bruderholz, Switzerland, 4101

Status
Completed
 
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Lugano, Switzerland, 6900

Status
Completed
 
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Brescia, Italy, 25123

Status
Completed
 
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Milano, Italy, 20138

Status
Completed
 
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Verona, Italy, 37045

Status
Completed
 
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Pavia, Italy, 27100

Status
Completed
 
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Milano, Italy, 20017

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Completed
 
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MECHELEN, Belgium, 2800

Status
Completed
 
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MOL, Belgium, 2400

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Completed
 
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ROESELARE, Belgium, 8800

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Completed
 
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GILLY, Belgium, 6060

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Completed
 
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HEERENVEEN, Netherlands, 8441 PW

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Completed
 
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Praha 10, Czech Republic, 10034

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Completed
 
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Praha 6, Czech Republic, 169 02

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Completed
 
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Praha 2, Czech Republic, 12808

Status
Completed
 
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Fakultni nemocnice Ostrava

Ostrava, Czech Republic, 708 52

Status
Terminated
 
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Investigative Site

Hradec kralove, Czech Republic, 500 05

Status
Completed
 
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Ashkelon, Israel, 7830604

Status
Completed
 
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Petah 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

Status
Completed
 
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Tel Aviv, Israel, 6423906

Status
Completed
 
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Afula, Israel, 1834111

Status
Completed
 
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Budapest, Hungary, 1032

Status
Completed
 
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Columbus, United States, 43210

Status
Completed
 
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Detroit, United States, 48202

Status
Completed
 
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Krakow, Poland, 31-202

Status
Completed
 
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Lodz, Poland, 92-213

Status
Completed
 
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Poznan, Poland, 61-848

Status
Completed
 
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Legnica, Poland, 59-220

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Completed
 
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Bialystok, Poland, 15-276

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Completed
 
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Warszawa, Poland, 02-507

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Completed
 
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Olsztyn, Poland, 10-010

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Completed
 
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Sendai, Japan, 981-3133

Status
Completed
 
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Meguro-ku, Japan, 152-8902

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Completed
 
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Yokohama, Japan, 236-0051

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Completed
 
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Sagamihara, Japan, 252-5188

Status
Completed
 
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Kanazawa, Japan, 920-8650

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Completed
 
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Fukui, Japan, 910-8526

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Completed
 
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Takatsuki, Japan, 569-1096

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Completed
 
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Himeji, Japan, 670-0981

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Completed
 
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Komatsushima, Japan, 773-8502

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Completed
 
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Tokushima, Japan, 770-8539

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Completed
 
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Hiroshima, Japan, 734-8530

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Completed
 
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Kumamoto, Japan, 862-8505

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Completed
 
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Nagasaki, Japan, 850-8555

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Completed
 
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Como, Italy, 22020

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Completed
 
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Ancona, Italy, 60126

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Completed
 
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BRUGGE, Belgium, 8000

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Completed
 
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Investigative Site

Malmö, Sweden, 205 02

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Completed
 
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Stockholm, Sweden, 118 83

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Completed
 
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Helsingborg, Sweden, 251 87

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Completed
 
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Linköping, Sweden, 581 85

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Completed
 
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Viborg, Denmark, 8800

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Completed
 
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Hellerup, Denmark, DK-2900

Status
Completed
 
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Aalborg, Denmark, 9000

Status
Completed
 
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Kistarcsa, Hungary, H-2143

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Completed
 
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Karlstad, Sweden, 651 85

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Completed
 
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Nashville, United States, 37232-8802

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Completed
 
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Investigative Site

Taipei, Taiwan, China, 100

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Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 11217

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Completed
 
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Kaohsiung, Taiwan, China, 813

Status
Completed
 
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Investigative Site

Zürich, Switzerland, 8091

Status
Completed
 
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Investigative Site

PARIS CEDEX 15, France, 75908

Status
Completed
 
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Investigative Site

PESSAC, France, 33604

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Completed
 
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Investigative Site

Lille Cedex, France, 59037

Status
Completed
 
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Investigative Site

LA TRONCHE, France, 38700

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Completed
 
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Investigative Site

Örebro, Sweden, 701 85

Status
Completed
 
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Investigative Site

Toyama, Japan, 930-8550

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Completed
 
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AMSTERDAM, Netherlands, 1105 AZ

Status
Completed
 
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Investigative Site

Minato-ku, Japan, 106-0031

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Completed
 
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Investigative Site

Yokosuka, Japan, 238-8567

Status
Completed
 
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Investigative Site

Yao, Japan, 581-0011

Status
Completed
 
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Iizuka, Japan, 820-8505

Status
Completed
 
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Investigative Site

Zrifin, Israel, 7030000

Status
Completed
 
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Investigative Site

Jerusalem, Israel, 9103102

Status
Completed
 
Locations

Investigative Site

Praha 4, Czech Republic, 140 21

Status
Completed
 
Locations

Investigative Site

Macon, United States, 31201

Status
Completed
 
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Investigative Site

Aarhus N, Denmark, 8200

Status
Completed
 
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Investigative Site

Wilmington, United States, 19803

Status
Completed
 
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Investigative Site

Minneapolis, United States, 55422

Status
Completed
 
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Investigative Site

GENT, Belgium, 9000

Status
Completed
 
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Investigative Site

Kromeriz, Czech Republic, 767 01

Status
Completed
 
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Investigative Site

Charleston, United States, 29425

Status
Completed
 
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Investigative Site

Jacksonville, United States, 32209

Status
Completed
 
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Investigative Site

New Orleans, United States, 70112-1396

Status
Completed
 
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Investigative Site

Germantown, United States, 38138

Status
Completed
 
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Investigative Site

Stevenage, United Kingdom, SG1 4AB

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Completed
 
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Investigative Site

Chesterfield, United Kingdom, S44 5DX

Status
Completed
 
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Investigative Site

Hobart, Australia, 7000

Status
Completed
 
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Investigative Site

Prahran, Australia, 3181

Status
Completed
 
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Investigative Site

DARLINGHURST, Australia, 2010

Status
Completed
 
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Investigative Site

Ft. Lauderdale, United States, 33308

Status
Completed
 
Locations

Investigative Site

Jackson, United States, 39216-4505

Status
Completed
 
Locations

Investigative Site

HUY, Belgium, 4500

Status
Completed
 
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Investigative Site

Sofia, Bulgaria, 1527

Status
Completed
 
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Investigative Site

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

Status
Completed
 
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Investigative Site

Sofia, Bulgaria, 1202

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Completed
 
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Investigative Site

Sofia, Bulgaria, 1309

Status
Completed
 
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Investigative Site

Sofia, Bulgaria, 1233

Status
Completed
 
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Investigative Site

Stara Zagora, Bulgaria, 6000

Status
Completed
 
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Investigative Site

Seoul, South Korea, 138-736

Status
Completed
 
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Investigative Site

Tiberias, Israel, 1528001

Status
Completed
 
Locations

Investigative Site

Ureshino, Japan, 843-0393

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H2W 1T8

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H1T 1C8

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46010

Status
Completed
 
Locations

Investigative Site

Naha, Japan, 902-8511

Status
Completed
 
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Investigative Site

Naples, United States, 34102

Status
Completed
 
Locations

Investigative Site

Arezzo, Italy, 52044

Status
Completed
 
Locations

Investigative Site

Bergamo, Italy, 24127

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20149

Status
Completed
 
Locations

Investigative Site

Rouen, France, 76031

Status
Completed
 
Locations

Investigative Site

BRON Cedex, France, 69677

Status
Completed
 
Locations

Investigative Site

Linz, Austria, 4020

Status
Completed
 
Locations

Investigative Site

VELDHOVEN, Netherlands, 5504 DB

Status
Completed
 
Locations

Investigative Site

Fairfield, United States, 45014

Status
Completed
 
Locations

Investigative Site

Liestal, Switzerland, 4410

Status
Completed
 
Locations

Investigative Site

Slany, Czech Republic, 274 01

Status
Completed
 
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Investigative Site

Hannover, Germany, 30625

Status
Completed
 
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Investigative Site

Bad Homburg, Germany, 61348

Status
Completed
 
Locations

Investigative Site

Athens, Greece, 11527

Status
Completed
 
Locations

Investigative Site

Nea Ionia, Greece, 14233

Status
Completed
 
Locations

Investigative Site

New Taipei City, Taiwan, China, 220

Status
Completed
 

Trial Design