Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients

A 24-week Multi-center, Double-blind, Placebo Controlled Dose-range Finding Study to Investigate the Efficacy and Safety of Oral QBW251 in COPD Patients on Triple Inhaled Therapy (LABA / LAMA / ICS)

ClinicalTrials.gov Identifier: NCT04072887

Novartis Reference Number: CQBW251B2201

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in COPD patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple combination therapy of LABA, LAMA and ICS with respect to trough FEV1 change from baseline after 12 weeks of treatment.

Condition 
Pulmonary Disease, Chronic Obstructive
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
956 participants
Start date 
Sep 12, 2019
Completion date 
Oct 14, 2021
Gender 
All
Age(s)
40 Years and older (Adult, Older Adult)

Interventions

Drug
QBW251
QBW251 b.i.d
Drug
Placebo
Placebo b.i.d

Eligibility Criteria

Inclusion Criteria:

Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening.
Patients featuring chronic bronchitis

Exclusion Criteria:

Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or between screening and randomization.
Patients with any documented history of asthma, or with an onset of chronic respiratory symptoms, including a COPD diagnosis, prior to age 40 years.
Patients with a body mass index (BMI) of more than 40 kg/m2.
Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations.
Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation.
Other protocol-defined inclusion/exclusion criteria may apply

Study Locations

United States
Novartis Investigative Site
Recruiting
Andalusia, 36420
Alabama
United States
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Los Angeles, 90025
California
United States
Novartis Investigative Site
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San Diego, 92117
California
United States
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Westminster, 92683
California
United States
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Boulder, 80301
Colorado
United States
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Ormond Beach, 32174
Florida
United States
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Sarasota, 34233
Florida
United States
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Winter Park, 32789
Florida
United States
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River Forest, 60305
Illinois
United States
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Florence, 41042
Kentucky
United States
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Crowley, 70526
Louisiana
United States
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New Orleans, 70115
Louisiana
United States
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Zachary, 70791
Louisiana
United States
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Livonia, 48152
Michigan
United States
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Edina, 55435
Minnesota
United States
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Minneapolis, 55407
Minnesota
United States
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Withdrawn
Minneapolis, 55407
Minnesota
United States
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Saint Charles, 63301
Missouri
United States
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Saint Louis, 63141
Missouri
United States
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Omaha, 68134
Nebraska
United States
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Charlotte, 28207
North Carolina
United States
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Gastonia, 28054
North Carolina
United States
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Shelby, 28150
North Carolina
United States
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Columbus, 43215
Ohio
United States
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Medford, 97504
Oregon
United States
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El Paso, 79903
Texas
United States
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Houston, 77030
Texas
United States
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McKinney, 75069
Texas
United States
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Midlothian, 23114
Virginia
United States
Argentina
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Berazategui, 1888
Buenos Aires
Argentina
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Caba, 1407
Buenos Aires
Argentina
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Mar del Plata, 7600
Buenos Aires
Argentina
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Concepcion del Uruguay, 3260
Entre Ríos
Argentina
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Rosario, S2000DBS
Santa Fe
Argentina
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Ciudad Autonoma de Bs As, C1425FVH
-
Argentina
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Mendoza, 5500
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Argentina
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Salta, 4000
-
Argentina
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Santa Fe, S3000FIL
-
Argentina
Australia
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South Brisbane, 4101
Queensland
Australia
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Bedford Park, 5042
South Australia
Australia
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Clayton, 3168
Victoria
Australia
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Footscray, 3011
Victoria
Australia
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Spearwood, 6163
Western Australia
Australia
Austria
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Feldbach, 8330
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Austria
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Grieskirchen, 4710
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Austria
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Thalheim bei Wels, 4600
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Austria
Belgium
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Erpent, 5100
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Belgium
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Leuven, 3000
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Belgium
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Liege, 4000
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Belgium
Canada
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Sherwood Park, T8H 0N2
Alberta
Canada
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Toronto, M5T 3A9
Ontario
Canada
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Montreal, H4A 3J1
Quebec
Canada
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Sainte Foy, G1V 4G5
Quebec
Canada
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Sherbrooke, J1H 5N4
Quebec
Canada
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St-Charles-Borromee, J6E 2B4
Quebec
Canada
Czechia
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Liberec, 460 05
Czech Republic
Czechia
Novartis Investigative Site
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Ostrava Poruba, 708 68
Czech Republic
Czechia
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Teplice, 415 01
Czech Republic
Czechia
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Varnsdorf, 40747
-
Czechia
Denmark
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Aalborg, DK 9000
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Denmark
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Copenhagen, DK-2400
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Denmark
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Hvidovre, 2650
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Denmark
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Vejle, 7100
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Denmark
France
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Montpellier cedex 5, 34059
Herault
France
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Lyon Cedex 04, 69317
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France
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Pessac Cedex, 33604
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France
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Reims, 51092
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France
Germany
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Berlin, 10119
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Germany
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Berlin, 12157
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Germany
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Berlin, 12159
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Germany
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Bonn, 53105
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Germany
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Frankfurt, 60596
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Germany
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Gerlingen, 70839
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Germany
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Halle, 06108
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Germany
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Hamburg, 20354
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Germany
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Landsberg, 86899
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Germany
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Leipzig, 04207
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Germany
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Leipzig, 04275
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Germany
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Leipzig, 04357
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Germany
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Mainz, 55131
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Germany
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Marburg, D-35037
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Germany
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Mittweida, 09648
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Germany
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Witten, 58452
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Germany
Greece
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Thessaloniki, 564 29
GR
Greece
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Thessaloniki, 570 10
GR
Greece
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Heraklion Crete, 711 10
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Greece
Guatemala
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Guatemala City, 01010
GTM
Guatemala
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Guatemala City, 01011
GTM
Guatemala
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Guatemala City, 01011
-
Guatemala
Hong Kong
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New Territories,
-
Hong Kong
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Pokfulam,
-
Hong Kong
Hungary
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Budapest, 1106
-
Hungary
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Godollo, 2100
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Hungary
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Komarom, 2900
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Hungary
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Mako, 6900
-
Hungary
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Pecs, 7635
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Hungary
Italy
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Bergamo, 24127
BG
Italy
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Modena, 41124
MO
Italy
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Siena, 53100
SI
Italy
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Negrar, 37024
VR
Italy
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Napoli, 80131
-
Italy
Japan
Novartis Investigative Site
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Nagoya, 457 8510
Aichi
Japan
Novartis Investigative Site
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Nagoya, 457-8511
Aichi
Japan
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Fukuoka city, 811-1394
Fukuoka
Japan
Novartis Investigative Site
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Fukuoka-city, 819-8555
Fukuoka
Japan
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Kasuga-city, 816-0813
Fukuoka
Japan
Novartis Investigative Site
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Koga city, 811 3195
Fukuoka
Japan
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Yanagawa-city, 832-0059
Fukuoka
Japan
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Mizunami-city, 509 6134
Gifu
Japan
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Asahikawa-city, 070-8644
Hokkaido
Japan
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Sapporo, 062-8618
Hokkaido
Japan
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Withdrawn
Higashiibaraki-gun, 311-3193
Ibaraki
Japan
Novartis Investigative Site
Recruiting
Naka-gun, 319-1113
Ibaraki
Japan
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Kanazawa, 920-0853
Ishikawa
Japan
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Kawasaki-city, 210-0852
Kanagawa
Japan
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Sagamihara-city, 228-8522
Kanagawa
Japan
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Matsusaka-city, 515-8544
Mie
Japan
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Sendai-shi, 983 8520
Miyagi
Japan
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Kawachinagano, 586-8521
Osaka
Japan
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Kishiwada-city, 596-8501
Osaka
Japan
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Sakai, 591-8555
Osaka
Japan
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Toyonaka, 560-8552
Osaka
Japan
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Chuo ku, 104-0031
Tokyo
Japan
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Chuo-ku, 103-0003
Tokyo
Japan
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Chuo-ku, 103-0028
Tokyo
Japan
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Meguro-ku, 152-8902
Tokyo
Japan
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Setagaya-ku, 158-8531
Tokyo
Japan
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Shinagawa, 140-8522
Tokyo
Japan
Novartis Investigative Site
Withdrawn
Shinjuku ku, 162 8655
Tokyo
Japan
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Toshima ku, 170 0003
Tokyo
Japan
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Yamagata city, 990-8533
Yamagata
Japan
Novartis Investigative Site
Withdrawn
Saitama, 330-8553
-
Japan
Korea, Republic of
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Wonju, 26427
Gangwon-do
Korea, Republic of
Novartis Investigative Site
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Seoul, 03312
Korea
Korea, Republic of
Novartis Investigative Site
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Seoul, 06591
Seocho Gu
Korea, Republic of
Novartis Investigative Site
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Daegu, 705703
-
Korea, Republic of
Novartis Investigative Site
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Incheon, 21431
-
Korea, Republic of
Netherlands
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Horn, 6085 NM
Limburg
Netherlands
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Eindhoven, 5623 EJ
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Netherlands
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Harderwijk, 3840 AC
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Netherlands
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Helmond, 5707 HA
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Netherlands
Philippines
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Lipa City, 4217
Batangas
Philippines
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Iloilo city, 5000
Iloilo
Philippines
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Iloilo City, 5000
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Philippines
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Manila, 1000
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Philippines
Poland
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Grudziadz, 86-300
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Poland
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Katowice, 40-648
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Poland
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Zawadzkie, 47-120
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Poland
Slovakia
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Bardejov, 085 01
Slovak Republic
Slovakia
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Bojnice, 972 01
Slovak Republic
Slovakia
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Humenne, 066 01
Slovak Republic
Slovakia
Novartis Investigative Site
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Poprad, 058 01
-
Slovakia
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Presov, 080 01
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Slovakia
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Spisska Nova Ves, 052 01
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Slovakia
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Vysne Hagy, 5984
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Slovakia
Spain
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Sevilla, 41014
Andalucia
Spain
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Barcelona, 08036
Cataluña
Spain
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Alzira, 46600
Comunidad Valenciana
Spain
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Logrono, 26006
La Rioja
Spain
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Barcelona, 08035
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Spain
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Girona, 17005
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Spain
Thailand
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Songkhla, 90110
Hat Yai
Thailand
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Khon Kaen, 40002
THA
Thailand
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Bangkok, 10330
-
Thailand
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Bangkok, 10400
-
Thailand
Turkey
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Adana, 01330
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Turkey
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Izmir, 35040
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Turkey
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Mersin, 33079
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Turkey

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Phone: 
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