Trial Condition(s):

Heart Failure

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

Bayer Identifier:

15829

ClinicalTrials.gov Identifier:

NCT01951638

EudraCT Number:

2013-002288-25

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 diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)

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
477
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

Pittsburgh, United States, 15212

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
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Valencia, Spain, 46026

Status
Completed
 
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Majadahonda, Spain, 28222

Status
Completed
 
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Barcelona, Spain, 08023

Status
Completed
 
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Barcelona, Spain, 08003

Status
Completed
 
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Santander, Spain, 39008

Status
Completed
 
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Many locations, 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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Singapore, Singapore, 119228

Status
Completed
 
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Homburg, Germany, 66421

Status
Completed
 
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Erfurt, Germany, 99089

Status
Completed
 
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Köln, Germany, 50937

Status
Completed
 
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Greifswald, Germany, 17475

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Completed
 
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Hamburg, Germany, 20246

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Completed
 
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München, Germany, 80331

Status
Completed
 
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Münster, Germany, 48149

Status
Completed
 
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Graz, Austria, 8036

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Completed
 
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Wien, Austria, 1220

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Completed
 
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Salzburg, Austria, 5020

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Completed
 
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St. Pölten, Austria, 3100

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Completed
 
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Wien, Austria, 1090

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Completed
 
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Buffalo, United States, 14215

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Completed
 
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Fountain Valley, United States, 92708

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Completed
 
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Milwaukee, United States, 53215

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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

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Completed
 
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Sneek, Netherlands, 8601 ZR

Status
Completed
 
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LEEUWARDEN, Netherlands, 8934 AD

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Completed
 
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Szekesfehervar, Hungary, 8000

Status
Completed
 
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Budapest, Hungary, 1097

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Completed
 
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Genève, Switzerland, 1205

Status
Completed
 
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Lugano, Switzerland, 6900

Status
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

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Completed
 
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Brescia, Italy, 25123

Status
Completed
 
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Pavia, Italy, 27100

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Completed
 
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Milano, Italy, 20017

Status
Completed
 
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MECHELEN, Belgium, 2800

Status
Completed
 
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MOL, Belgium, 2400

Status
Completed
 
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ROESELARE, Belgium, 8800

Status
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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Ashkelon, Israel, 7830604

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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

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Completed
 
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Tel Aviv, Israel, 6423906

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Completed
 
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Afula, Israel, 1834111

Status
Completed
 
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Detroit, United States, 48202

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Completed
 
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Krakow, Poland, 31-202

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Completed
 
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Lodz, Poland, 92-213

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Completed
 
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Poznan, Poland, 61-848

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Completed
 
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Lodz, Poland, 93-513

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Completed
 
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Bialystok, Poland, 15-276

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Completed
 
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Olsztyn, Poland, 10-010

Status
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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Stockholm, Sweden, 118 83

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Completed
 
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Helsingborg, Sweden, 251 87

Status
Completed
 
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Linköping, Sweden, 581 85

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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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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

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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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Karlstad, Sweden, 652 30

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Completed
 
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Nashville, United States, 37232-8802

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Completed
 
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Taipei, Taiwan, China, 100

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Completed
 
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Taipei, Taiwan, China, 11217

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Completed
 
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Taoyuan, Taiwan, China, 33305

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Completed
 
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Kaohsiung, Taiwan, China, 813

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Completed
 
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Newark, United States, 07103

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Completed
 
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Iowa City, United States, 52242

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Completed
 
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PESSAC, France, 33604

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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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Örebro, Sweden, 701 85

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Completed
 
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Toyama, Japan, 930-8550

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Completed
 
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Chicago, United States, 60611-2908

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Completed
 
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AMSTERDAM, Netherlands, 1105 AZ

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Completed
 
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Minato-ku, Japan, 106-0031

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Completed
 
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Yokosuka, Japan, 238-8567

Status
Completed
 
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Sakai, Japan, 599-8247

Status
Completed
 
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Iizuka, Japan, 820-8505

Status
Completed
 
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Zrifin, Israel, 7030000

Status
Completed
 
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Jerusalem, Israel, 9103102

Status
Completed
 
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Investigative Site

Praha 4, Czech Republic, 140 21

Status
Completed
 
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Investigative Site

Macon, United States, 31201

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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Kromeriz, Czech Republic, 767 01

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Completed
 
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Charleston, United States, 29425

Status
Completed
 
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New Orleans, United States, 70112-1396

Status
Completed
 
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Germantown, United States, 38138

Status
Completed
 
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Stevenage, United Kingdom, SG1 4AB

Status
Completed
 
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Chesterfield, United Kingdom, S44 5DX

Status
Completed
 
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Investigative Site

Brisbane, Australia, 4029

Status
Completed
 
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Investigative Site

Hobart, Australia, 7000

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
 
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Investigative Site

Jackson, United States, 39216-4505

Status
Completed
 
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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

Montreal, Canada, H2W 1T8

Status
Completed
 
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Investigative Site

Sofia, Bulgaria, 1202

Status
Completed
 
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Investigative Site

Sofia, Bulgaria, 1309

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Completed
 
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Investigative Site

Sofia, Bulgaria, 1233

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Completed
 
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Stara Zagora, Bulgaria, 6000

Status
Completed
 
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Seoul, South Korea, 138-736

Status
Completed
 
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Haifa, Israel, 3109601

Status
Completed
 
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Tiberias, Israel, 1528001

Status
Completed
 
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Takamatsu, Japan, 760-0018

Status
Completed
 
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Investigative Site

Montreal, Canada, H1T 1C8

Status
Completed
 
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Investigative Site

Linz, Austria, 4020

Status
Completed
 
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Investigative Site

El Palmar, Spain, 30120

Status
Completed
 
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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
 
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Investigative Site

Bergamo, Italy, 24127

Status
Completed
 
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Investigative Site

Milano, Italy, 20149

Status
Completed
 
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Investigative Site

Bad Krozingen, Germany, 79189

Status
Completed
 
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Investigative Site

Burgas, Bulgaria, 8018

Status
Completed
 
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Investigative Site

Redcliffe, Australia, 4020

Status
Completed
 
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Investigative Site

Brisbane, Australia, 4064

Status
Completed
 
Locations

Investigative Site

BRON Cedex, France, 69677

Status
Completed
 
Locations

Investigative Site

Krakow, Poland, 31-121

Status
Completed
 
Locations

Investigative Site

Szczecin, Poland, 70-965

Status
Completed
 
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Investigative Site

Holbaek, Denmark, 4300

Status
Completed
 
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Investigative Site

Hannover, Germany, 30625

Status
Completed
 
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Investigative Site

Linz, Austria, 4010

Status
Completed
 
Locations

Investigative Site

Bad Homburg, Germany, 61348

Status
Completed
 
Locations

Investigative Site

Randers, Denmark, 8930

Status
Completed
 
Locations

Investigative Site

Chaidari, Greece, 12462

Status
Completed
 
Locations

Investigative Site

Athens, Greece, 11527

Status
Completed
 
Locations

Investigative Site

Nea Ionia / Athens, Greece, 142 33

Status
Completed
 
Locations

Investigative Site

New Taipei City, Taiwan, China, 220

Status
Completed
 
Locations

Investigative Site

Lisboa, Portugal, 1449-005

Status
Completed
 
Locations

Investigative Site

Lisboa, Portugal, 1500-650

Status
Completed
 
Locations

Investigative Site

Almada, Portugal, 2801-951

Status
Completed
 
Locations

Investigative Site

Lisboa, Portugal, 1649-035

Status
Completed
 
Locations

Investigative Site

Uji, Japan, 611-0041

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 558-8558

Status
Completed
 
Locations

Investigative Site

Higashiibaraki, Japan, 311-3193

Status
Completed
 

Trial Design