ClinicalTrials.gov

History of Changes for Study: NCT02200614
Efficacy and Safety Study of BAY1841788 (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer (ARAMIS) (ARAMIS)
Latest version (submitted June 2, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 23, 2014 None (earliest Version on record)
2 August 5, 2014 Study Status and Contacts/Locations
3 September 23, 2014 Recruitment Status, Study Status and Contacts/Locations
4 February 13, 2015 Contacts/Locations, Sponsor/Collaborators, Study Identification and Study Status
5 May 13, 2015 Contacts/Locations, Arms and Interventions, Study Status, Study Identification, Study Description, Eligibility, Outcome Measures and Conditions
6 May 29, 2015 Contacts/Locations and Study Status
7 June 18, 2015 Contacts/Locations and Study Status
8 July 17, 2015 Contacts/Locations and Study Status
9 August 17, 2015 Contacts/Locations and Study Status
10 September 16, 2015 Contacts/Locations and Study Status
11 October 16, 2015 Study Status and Contacts/Locations
12 November 13, 2015 Contacts/Locations and Study Status
13 December 11, 2015 Contacts/Locations and Study Status
14 January 11, 2016 Contacts/Locations and Study Status
15 February 2, 2016 Contacts/Locations and Study Status
16 March 4, 2016 Contacts/Locations and Study Status
17 April 1, 2016 Contacts/Locations and Study Status
18 May 3, 2016 Contacts/Locations and Study Status
19 May 26, 2016 Contacts/Locations, Study Description and Study Status
20 June 27, 2016 Contacts/Locations and Study Status
21 July 25, 2016 Contacts/Locations and Study Status
22 August 18, 2016 Contacts/Locations, Outcome Measures, Study Description, Study Status, Eligibility, Arms and Interventions, Sponsor/Collaborators and Study Identification
23 September 13, 2016 Contacts/Locations and Study Status
24 October 13, 2016 Contacts/Locations and Study Status
25 November 14, 2016 Contacts/Locations, Study Status and Eligibility
26 December 14, 2016 Contacts/Locations and Study Status
27 January 13, 2017 Contacts/Locations and Study Status
28 February 10, 2017 Contacts/Locations and Study Status
29 March 9, 2017 Study Status and Contacts/Locations
30 April 5, 2017 Contacts/Locations, Study Status and Oversight
31 May 5, 2017 Contacts/Locations and Study Status
32 June 5, 2017 Contacts/Locations and Study Status
33 July 5, 2017 Contacts/Locations and Study Status
34 August 3, 2017 Contacts/Locations and Study Status
35 August 31, 2017 Contacts/Locations and Study Status
36 September 26, 2017 Contacts/Locations, Oversight and Study Status
37 October 26, 2017 Contacts/Locations and Study Status
38 November 27, 2017 Contacts/Locations and Study Status
39 December 27, 2017 Study Status
40 January 25, 2018 Contacts/Locations and Study Status
41 February 26, 2018 Recruitment Status, Contacts/Locations, Study Status and Study Design
42 March 29, 2018 Arms and Interventions, Study Status, Study Identification and Study Design
43 April 27, 2018 Contacts/Locations and Study Status
44 May 28, 2018 Study Status
45 June 27, 2018 Study Status
46 July 27, 2018 Contacts/Locations and Study Status
47 August 24, 2018 Contacts/Locations and Study Status
48 September 10, 2018 Contacts/Locations, Study Status and Study Design
49 November 28, 2018 Contacts/Locations, Study Status and Study Design
50 December 11, 2018 Study Status and Contacts/Locations
51 January 3, 2019 Contacts/Locations and Study Status
52 February 21, 2019 Contacts/Locations and Study Status
53 March 27, 2019 Study Status
54 May 23, 2019 Contacts/Locations and Study Status
55 June 20, 2019 Study Status
Show
Results Submission Events
56 October 9, 2019 Study Status, Outcome Measures, Document Section, Results, Contacts/Locations, Eligibility and Arms and Interventions
57 November 8, 2019 Study Status and Outcome Measures
58 December 9, 2019 Study Status and Contacts/Locations
59 January 7, 2020 Study Status
60 February 6, 2020 Arms and Interventions and Study Status
61 March 5, 2020 Study Status and Contacts/Locations
62 April 3, 2020 Document Section, Study Status and Contacts/Locations
63 May 7, 2020 Contacts/Locations and Study Status
64 June 9, 2020 Study Status and Contacts/Locations
65 July 9, 2020 Contacts/Locations and Study Status
66 August 17, 2020 Contacts/Locations and Study Status
67 September 29, 2020 Adverse Events, Participant Flow, Outcome Measures, Study Status, Baseline Characteristics and Contacts/Locations
68 November 10, 2020 Study Status and Contacts/Locations
69 December 10, 2020 Study Status
70 January 7, 2021 Contacts/Locations and Study Status
71 February 8, 2021 Study Status
72 March 10, 2021 Study Status and Contacts/Locations
73 April 12, 2021 Contacts/Locations and Study Status
74 May 12, 2021 Study Status and Contacts/Locations
75 June 21, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
76 July 15, 2021 Study Status, Study Design and Study Identification
77 June 2, 2022 Adverse Events, Participant Flow, Document Section, Outcome Measures, Contacts/Locations, Study Status, Baseline Characteristics and References
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Study NCT02200614
Submitted Date:  September 16, 2015 (v10)

Open or close this module Study Identification
Unique Protocol ID: 17712
Brief Title: Efficacy and Safety Study of BAY1841788 (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer (ARAMIS) (ARAMIS)
Official Title: A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF ODM-201 IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Secondary IDs: 2013-003820-36 [EudraCT Number]
Open or close this module Study Status
Record Verification: September 2015
Overall Status: Recruiting
Study Start: September 2014
Primary Completion: March 2018 [Anticipated]
Study Completion: June 2020 [Anticipated]
First Submitted: July 22, 2014
First Submitted that
Met QC Criteria:
July 23, 2014
First Posted: July 25, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 16, 2015
Last Update Posted: September 17, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bayer
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastaticcastration-resistant prostate cancer.
Detailed Description: This study was transferred from ORION to Bayer in February 2015. Former ORION product ODM-201 has been renamed to BAY1841788.
Open or close this module Conditions
Conditions: Prostate Cancer Non-Metastatic
Castration-Resistant
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 1500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: BAY1841788 (ODM-201) Drug: BAY1841788 (ODM-201)
BAY1841788 (ODM-201) tablets 2 x 300mg bid
Placebo Comparator: Placebo Drug: Placebo
Matching placebo tablets x 2 bid
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Metastasis-Free Survival
[ Time Frame: Up to 72 months ]

Time from randomisation to evidence of metastasis or death from any cause, whichever occurs first
Secondary Outcome Measures:
1. Overall Survival
[ Time Frame: Up to 72 months ]

Date of death and primary cause of death will be recorded
2. Time to first symptomatic skeletal event (SSE)
[ Time Frame: Up to 72 months ]

Date of first SSE will be recorded
3. Time to initiation of first cytotoxic chemotherapy
[ Time Frame: Up to 72 months ]

Name and start date of cytotoxic chemotherapy treatment will be recorded
4. Time to pain progression
[ Time Frame: Up to 72 months ]

Date of pain progression will be recorded
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
  • Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
  • Prostate-specific antigen doubling time of ≤ 10 months and PSA > 2ng/ml.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.
  • Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.
  • Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.

Exclusion Criteria:

  • History of metastatic disease or presence of detectable metastases.
  • Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
  • Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.
  • Use of estrogens, 5-α reductase inhibitors or AR inhibitors.
  • Prior chemotherapy or immunotherapy for prostate cancer.
  • Use of systemic corticosteroid.
  • Radiation therapy within 12 weeks before randomisation.
  • Severe or uncontrolled concurrent disease, infection or co-morbidity.
  • Ttreatment with bisphosphonate or denosumab within 12 weeks before randomisation.
  • Known hypersensitivity to the study treatment or any of its ingredients.
  • Major surgery within 28 days before randomisation.
  • Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
  • Uncontrolled hypertension.
  • Prior malignancy.
  • Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
  • Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
  • Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.
Open or close this module Contacts/Locations
Central Contact Person: Bayer Clinical Trials Contact
Email: clinical-trials-contact@bayerhealthcare.com
Central Contact Backup: For more information for participation into this trial, 646-776-7532 (local)
Telephone: 844-229-3710 (Toll Free) ]
Email: Bayer@emergingmed.com
Study Officials: Bayer Study Director
Study Director
Bayer
Locations: United States, Alabama
[Recruiting]
Homewood, Alabama, United States, 35209
United States, Alaska
[Recruiting]
Anchorage, Alaska, United States, 99503
United States, California
[Not yet recruiting]
Fountain Valley, California, United States, 92708
[Recruiting]
La Jolla, California, United States, 92093
[Recruiting]
Los Angeles, California, United States, 90048
[Recruiting]
San Diego, California, United States, 92120
United States, Colorado
[Not yet recruiting]
Denver, Colorado, United States, 80211
[Not yet recruiting]
Denver, Colorado, United States, 80220
[Recruiting]
Parker, Colorado, United States, 80134
United States, Florida
[Not yet recruiting]
Boca Raton, Florida, United States, 33486
[Not yet recruiting]
Miami Gardens, Florida, United States, 33169
[Recruiting]
Port St. Lucie, Florida, United States, 34952
United States, Idaho
[Recruiting]
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
[Not yet recruiting]
Chicago, Illinois, United States, 60612
[Not yet recruiting]
Evanston, Illinois, United States, 60201-1613
[Recruiting]
Springfield, Illinois, United States, 62704
United States, Indiana
[Recruiting]
Greenwood, Indiana, United States, 46143
[Recruiting]
Indianapolis, Indiana, United States, 46202
[Recruiting]
Jeffersonville, Indiana, United States, 47130
United States, Maryland
[Recruiting]
Annapolis, Maryland, United States, 21401
[Not yet recruiting]
Salisbury, Maryland, United States, 21801
United States, Michigan
[Not yet recruiting]
Grand Rapids, Michigan, United States, 49546
[Not yet recruiting]
Royal Oak, Michigan, United States, 48073
United States, Nebraska
[Not yet recruiting]
Omaha, Nebraska, United States, 68130
United States, New Jersey
[Not yet recruiting]
Lawrenceville, New Jersey, United States, 08648
United States, New York
[Not yet recruiting]
Bronx, New York, United States, 10469
[Not yet recruiting]
Brooklyn, New York, United States, 11215
[Not yet recruiting]
New York, New York, United States, 10016
United States, North Carolina
[Not yet recruiting]
Asheboro, North Carolina, United States, 27203
[Not yet recruiting]
Gastonia, North Carolina, United States, 28054
United States, Ohio
[Not yet recruiting]
Canton, Ohio, United States, 44718
[Recruiting]
Cincinnati, Ohio, United States, 45212-1979
[Recruiting]
Cleveland, Ohio, United States, 44195
United States, Oklahoma
[Not yet recruiting]
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
[Recruiting]
Bala Cynwyd, Pennsylvania, United States, 19004
[Not yet recruiting]
Bryn Mawr, Pennsylvania, United States, 19010
United States, South Carolina
[Not yet recruiting]
Charleston, South Carolina, United States, 29407
[Recruiting]
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
[Recruiting]
Nashville, Tennessee, United States, 37209
United States, Texas
[Recruiting]
Dallas, Texas, United States, 75231
[Not yet recruiting]
San Antonio, Texas, United States, 78240
United States, West Virginia
[Recruiting]
Wheeling, West Virginia, United States, 26003
Argentina
[Not yet recruiting]
Córdoba, Argentina, 5000
[Not yet recruiting]
Córdoba, Argentina, X5000HXL
[Not yet recruiting]
Córdoba, Argentina, X5016KEH
[Not yet recruiting]
La Rioja, Argentina, 5300
Argentina, Ciudad Auton. de Buenos Aires
[Not yet recruiting]
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1120AAT
Argentina, Santa Fe
[Not yet recruiting]
Rosario, Santa Fe, Argentina, S2000KZE
[Not yet recruiting]
Santa Fé, Santa Fe, Argentina, S3000FFV
Argentina, Tucuman
[Terminated]
San Miguel de Tucumán, Tucuman, Argentina, T4000GTB
[Not yet recruiting]
San Miguel de Tucumán, Tucuman, Argentina, T4000HXU
Australia
[Recruiting]
Kurralta Park, Australia, 5037
Australia, New South Wales
[Not yet recruiting]
Randwick, New South Wales, Australia, 2031
[Recruiting]
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
[Recruiting]
Douglas, Queensland, Australia, 4814
[Recruiting]
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
[Recruiting]
Fitzroy, Victoria, Australia, 3065
Austria
[Not yet recruiting]
Wien, Austria, 1020
[Not yet recruiting]
Wien, Austria, 1090
Austria, Oberösterreich
[Not yet recruiting]
Linz, Oberösterreich, Austria, 4021
[Not yet recruiting]
Wels, Oberösterreich, Austria, 4600
Belarus
[Not yet recruiting]
Brest, Belarus, 223041
[Recruiting]
Lesnoy, Belarus, 223040
[Not yet recruiting]
Minsk, Belarus, 220013
[Not yet recruiting]
Minsk, Belarus, 220114
[Not yet recruiting]
Minsk, Belarus, 223041
Belgium
[Not yet recruiting]
Bonheiden, Belgium, 2820
[Not yet recruiting]
Kortrijk, Belgium, 8500
[Not yet recruiting]
Leuven, Belgium, 3000
[Not yet recruiting]
Libramont, Belgium, 6800
[Not yet recruiting]
Liege, Belgium, 4000
[Not yet recruiting]
Sint-truiden, Belgium, 3800
[Not yet recruiting]
Wilrijk, Belgium, 2610
Brazil
[Not yet recruiting]
Rio de Janeiro, Brazil, 20551-030
Brazil, Ceará
[Not yet recruiting]
Fortaleza, Ceará, Brazil, 60430-230
Brazil, Goiás
[Not yet recruiting]
Goiânia, Goiás, Brazil, 74605-180
Brazil, Minas Gerais
[Not yet recruiting]
Belo Horizonte, Minas Gerais, Brazil, 30150-270
[Not yet recruiting]
Belo Horizonte, Minas Gerais, Brazil, 30150-320
[Not yet recruiting]
Juiz de Fora, Minas Gerais, Brazil, 36010-510
Brazil, Parana
[Not yet recruiting]
Curitiba, Parana, Brazil, 81520-060
Brazil, Rio Grande do Sul
[Not yet recruiting]
Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
[Not yet recruiting]
Porto Alegre, Rio Grande do Sul, Brazil, 90050 170
[Not yet recruiting]
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
[Not yet recruiting]
Porto Alegre, Rio Grande do Sul, Brazil
Brazil, Santa Catarina
[Not yet recruiting]
Itajaí, Santa Catarina, Brazil, 88301-220
Brazil, Sao Paulo
[Not yet recruiting]
Jau, Sao Paulo, Brazil, 17210-080
[Not yet recruiting]
Ribeirao Preto - SP, Sao Paulo, Brazil, 14048-900
[Not yet recruiting]
São Paulo, Sao Paulo, Brazil, 01209-000
[Not yet recruiting]
São Paulo, Sao Paulo, Brazil, 01236-030
[Not yet recruiting]
São Paulo, Sao Paulo, Brazil, 01246-000
[Not yet recruiting]
São Paulo, Sao Paulo, Brazil, 03102 002
[Not yet recruiting]
São Paulo, Sao Paulo, Brazil, 04039-004
Bulgaria
[Not yet recruiting]
Plovdiv, Bulgaria, 4000
[Not yet recruiting]
Sofia, Bulgaria, 1431
[Not yet recruiting]
Sofia, Bulgaria, 1606
[Not yet recruiting]
Varna, Bulgaria, 9000
Canada, British Columbia
[Not yet recruiting]
Victoria, British Columbia, Canada, V8T 2C1
Canada, Nova Scotia
[Not yet recruiting]
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
[Terminated]
Barrie, Ontario, Canada, L4M 7G1
[Not yet recruiting]
Burlington, Ontario, Canada, L7N 3V2
[Not yet recruiting]
Hamilton, Ontario, Canada, L8N 4A6
[Recruiting]
Kingston, Ontario, Canada, K7L 3J7
[Not yet recruiting]
London, Ontario, Canada, N6A 5W9
[Not yet recruiting]
Toronto, Ontario, Canada, M4N 3M5
[Not yet recruiting]
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
[Recruiting]
Granby, Quebec, Canada, J2G 8Z9
[Not yet recruiting]
Pointe-Claire, Quebec, Canada, H9R 4S3
Czech Republic
[Not yet recruiting]
Hradec Kralove, Czech Republic, 500 05
[Not yet recruiting]
Jablonec nad Nisou, Czech Republic, 466 60
[Not yet recruiting]
Karlovy Vary, Czech Republic, 360 66
[Recruiting]
Kolin, Czech Republic, 280 00
[Not yet recruiting]
Olomouc, Czech Republic, 775 20
[Not yet recruiting]
Opava, Czech Republic, 746 01
[Not yet recruiting]
Praha 10, Czech Republic, 10034
[Not yet recruiting]
Praha 2, Czech Republic, 120 00
[Not yet recruiting]
Praha 2, Czech Republic, 12808
[Not yet recruiting]
Praha 5, Czech Republic, 150 06
[Recruiting]
Praha 6, Czech Republic, 160 00
[Not yet recruiting]
Praha 8, Czech Republic, 180 81
Finland
[Recruiting]
Helsinki, Finland, 00290
[Recruiting]
Kuopio, Finland, FIN- 70211
[Recruiting]
Seinäjoki, Finland, FIN 60220
[Recruiting]
Tampere, Finland, 33500
[Recruiting]
Turku, Finland, FIN-20521
France
[Not yet recruiting]
Angers Cedex 01, France, 49033
[Not yet recruiting]
Bayonne, France, 64100
[Not yet recruiting]
Besancon, France, 25030
[Not yet recruiting]
Clermont Ferrand Cedex 1, France, 63011
[Not yet recruiting]
Creteil, France, 94010
[Not yet recruiting]
La Roche Sur Yon Cedex, France, 85025
[Not yet recruiting]
Montpellier, France, 34070
[Not yet recruiting]
Montpellier Cedex, France, 34298
[Not yet recruiting]
Nancy, France, 54100
[Not yet recruiting]
Nantes Cedex, France, 44093
[Not yet recruiting]
Paris, France, 75010
[Not yet recruiting]
Paris, France, 75014
[Not yet recruiting]
Paris Cedex 14, France, 75877
[Not yet recruiting]
Pierre Benite, France, 69495
[Not yet recruiting]
Poitiers Cedex, France, 86021
[Not yet recruiting]
Quimper, France, 29000
[Not yet recruiting]
Reims, France, 51056
[Not yet recruiting]
Rennes Cedex, France, 35033
[Not yet recruiting]
Rouen Cedex, France, 76031
[Not yet recruiting]
Suresnes, France, 92151
[Not yet recruiting]
Tours, France, 37044
[Not yet recruiting]
Villejuif Cedex, France, 94805
Germany
[Not yet recruiting]
Berlin, Germany, 10115
[Not yet recruiting]
Berlin, Germany, 12200
[Not yet recruiting]
Hamburg, Germany, 20246
[Not yet recruiting]
Hamburg, Germany, 22081
Germany, Baden-Württemberg
[Not yet recruiting]
Emmendingen, Baden-Württemberg, Germany, 79312
[Not yet recruiting]
Heidelberg, Baden-Württemberg, Germany, 69115
[Not yet recruiting]
Kirchheim unter Teck, Baden-Württemberg, Germany, 73230
[Not yet recruiting]
Mühlacker, Baden-Württemberg, Germany, 75417
[Recruiting]
Reutlingen, Baden-Württemberg, Germany, 72764
[Not yet recruiting]
Tübingen, Baden-Württemberg, Germany, 72076
[Not yet recruiting]
Waldshut-Tiengen, Baden-Württemberg, Germany, 79761
Germany, Bayern
[Not yet recruiting]
Nürnberg, Bayern, Germany, 90489
[Not yet recruiting]
Planegg, Bayern, Germany, 82152
Germany, Hessen
[Not yet recruiting]
Marburg, Hessen, Germany, 35039
Germany, Mecklenburg-Vorpommern
[Not yet recruiting]
Hagenow, Mecklenburg-Vorpommern, Germany, 19230
[Not yet recruiting]
Rostock, Mecklenburg-Vorpommern, Germany, 18107
Germany, Niedersachsen
[Not yet recruiting]
Hannover, Niedersachsen, Germany, 30625
[Recruiting]
Holzminden, Niedersachsen, Germany, 37603
[Not yet recruiting]
Osnabrück, Niedersachsen, Germany, 49076
Germany, Nordrhein-Westfalen
[Not yet recruiting]
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
[Not yet recruiting]
Köln, Nordrhein-Westfalen, Germany, 50931
[Not yet recruiting]
Mülheim, Nordrhein-Westfalen, Germany, 45468
[Not yet recruiting]
Münster, Nordrhein-Westfalen, Germany, 48149
[Not yet recruiting]
Wuppertal, Nordrhein-Westfalen, Germany, 42103
Germany, Rheinland-Pfalz
[Not yet recruiting]
Mainz, Rheinland-Pfalz, Germany, 55131
Germany, Saarland
[Not yet recruiting]
Homburg, Saarland, Germany, 66421
Germany, Sachsen
[Not yet recruiting]
Dresden, Sachsen, Germany, 01307
[Not yet recruiting]
Markkleeberg, Sachsen, Germany, 04416
Germany, Sachsen-Anhalt
[Not yet recruiting]
Magdeburg, Sachsen-Anhalt, Germany, 39112
Greece
[Not yet recruiting]
Abelokipi - Athens, Greece, 115 26
[Not yet recruiting]
Athens, Greece, 115 27
[Not yet recruiting]
Athens, Greece, 11522
[Not yet recruiting]
Athens, Greece, 11528
[Not yet recruiting]
Glyfada/Athens, Greece, 16675
[Not yet recruiting]
Ioannina, Greece, 45500
[Not yet recruiting]
Thessaloniki-Moudanion, Greece, 57001
Greece, Attica
[Not yet recruiting]
Athens, Attica, Greece, 11527
Hungary
[Recruiting]
Budapest, Hungary, 1085
[Recruiting]
Budapest, Hungary, 1145
[Not yet recruiting]
Budapest, Hungary, 1204
[Recruiting]
Debrecen, Hungary, 4032
[Not yet recruiting]
Gyor, Hungary, 9024
[Not yet recruiting]
Nyiregyhaza, Hungary, H-4400
[Not yet recruiting]
Szeged, Hungary, 6725
[Not yet recruiting]
Szekszard, Hungary, 7100
[Recruiting]
Szolnok, Hungary, H-5004
[Not yet recruiting]
Zalaegerszeg, Hungary, 8900
Israel
[Not yet recruiting]
Beer Sheva, Israel, 8410101
[Not yet recruiting]
Haifa, Israel, 31048
[Not yet recruiting]
Haifa, Israel, 35152
[Not yet recruiting]
Jerusalem, Israel, 9372212
[Not yet recruiting]
Nahariya, Israel, 2210001
[Not yet recruiting]
Ramat Gan, Israel, 5262000
[Not yet recruiting]
Tel Aviv, Israel, 6423906
[Not yet recruiting]
Zefat, Israel, 1311001
Italy
[Not yet recruiting]
Arezzo, Italy, 52100
[Not yet recruiting]
Catania, Italy, 95123
[Not yet recruiting]
Catanzaro, Italy, 88100
[Not yet recruiting]
Chieti, Italy, 66100
[Not yet recruiting]
Lecce, Italy, 73100
[Not yet recruiting]
Messina, Italy, 98125
[Not yet recruiting]
Milano, Italy, 20159
[Not yet recruiting]
Modena, Italy, 41124
[Not yet recruiting]
Napoli, Italy, 80131
[Not yet recruiting]
Napoli, Italy
[Not yet recruiting]
Palermo, Italy, 90127
[Recruiting]
Parma, Italy, 43100
[Not yet recruiting]
Roma, Italy, 00144
[Not yet recruiting]
Roma, Italy, 00189
[Not yet recruiting]
Siena, Italy, 53100
Italy, Como
[Not yet recruiting]
San Fermo della Battaglia, Como, Italy, 22020
Italy, Forlì
[Not yet recruiting]
Meldola, Forlì, Italy, 47014
Italy, Torino
[Not yet recruiting]
Candiolo, Torino, Italy, 10060
[Not yet recruiting]
Orbassano, Torino, Italy, 10043
Korea, Republic of
[Not yet recruiting]
Chungchungbuk-do, Korea, Republic of, 361-711
[Not yet recruiting]
Seoul, Korea, Republic of, 110-744
[Recruiting]
Seoul, Korea, Republic of, 120-752
[Recruiting]
Seoul, Korea, Republic of, 135-710
[Recruiting]
Seoul, Korea, Republic of, 137-701
[Recruiting]
Seoul, Korea, Republic of, 138-736
Korea, Republic of, Gwangju Gwang''yeogsi
[Recruiting]
Donggu,, Gwangju Gwang''yeogsi, Korea, Republic of, 501-757
Korea, Republic of, Seoul Teugbyeolsi
[Not yet recruiting]
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 135-720
Latvia
[Recruiting]
Jelgava, Latvia, LV-3001
[Recruiting]
Leipaja, Latvia, LV-3401
[Recruiting]
Riga, Latvia, LV-1001
[Recruiting]
Riga, Latvia, LV-1002
[Recruiting]
Riga, Latvia, LV-1038
Peru
[Not yet recruiting]
Lima, Peru, 27
[Not yet recruiting]
Lima, Peru, LIMA 11
[Not yet recruiting]
Lima, Peru, LIMA 18
[Not yet recruiting]
Lima, Peru, LIMA 27
Poland
[Not yet recruiting]
Elblag, Poland, 82-300
[Not yet recruiting]
Gdansk, Poland, 80-952
[Not yet recruiting]
Lodz, Poland, 90-302
[Not yet recruiting]
Lodz, Poland, 90-549
[Not yet recruiting]
Lublin, Poland, 20-718
[Not yet recruiting]
Otwock, Poland
[Not yet recruiting]
Rzeszow, Poland, 35- 922
[Not yet recruiting]
Siedlce, Poland, 08-110
[Terminated]
Warszawa, Poland, 02-005
[Not yet recruiting]
Warszawa, Poland, 02-507
[Not yet recruiting]
Warszawa, Poland, 02-616
[Not yet recruiting]
Warszawa, Poland, 02-781
[Recruiting]
Warszawa, Poland, 04-125
[Not yet recruiting]
Wroclaw, Poland, 50-556
[Recruiting]
Wroclaw, Poland, 54-144
Portugal
[Not yet recruiting]
Almada, Portugal, 2801-951
[Not yet recruiting]
Braga, Portugal, 4710-243
[Not yet recruiting]
Coimbra, Portugal, 3000-075
[Not yet recruiting]
Guimaraes, Portugal, 4835-044
[Not yet recruiting]
Lisboa, Portugal, 1093-023
[Not yet recruiting]
Lisboa, Portugal, 1150-199
[Not yet recruiting]
Lisboa, Portugal, 1349-019
[Not yet recruiting]
Lisboa, Portugal, 1400-038
[Not yet recruiting]
Lisboa, Portugal, 1500-650
[Recruiting]
Matosinhos, Portugal, 4464-513
[Not yet recruiting]
Porto, Portugal, 4200-319
Portugal, Porto
[Not yet recruiting]
Santa Maria da Feira, Porto, Portugal, 4520-211
Romania
[Recruiting]
Bucuresti, Romania, 22328
[Recruiting]
Bucuresti, Romania, 41345
[Recruiting]
Bucuresti, Romania, 50659
[Not yet recruiting]
Bucuresti, Romania, 75000
[Not yet recruiting]
Cluj-Napoca, Romania, 400132
[Recruiting]
Oradea, Romania, 410159
[Recruiting]
Targu-Mures, Romania, 540103
Russian Federation
[Not yet recruiting]
Arkhangelsk, Russian Federation, 163045
[Not yet recruiting]
Barnaul, Russian Federation, 656049
[Not yet recruiting]
Chelyabinsk, Russian Federation, 454087
[Recruiting]
Chelyabinsk, Russian Federation, 454087
[Recruiting]
Ivanovo, Russian Federation, 153040
[Not yet recruiting]
Kazan, Russian Federation, 420029
[Not yet recruiting]
Krasnoyarsk, Russian Federation, 660022
[Recruiting]
Moscow, Russian Federation, 105425
[Recruiting]
Moscow, Russian Federation, 125284
[Not yet recruiting]
Moscow, Russian Federation, 129301
[Recruiting]
Nizhny Novgorod, Russian Federation, 603001
[Recruiting]
Novosibirsk, Russian Federation, 630099
[Not yet recruiting]
Obninsk, Russian Federation, 249036
[Recruiting]
Omsk, Russian Federation, 644013
[Not yet recruiting]
Pyatigorsk, Russian Federation, 357502
[Not yet recruiting]
Rostov-on-Don, Russian Federation, 344022
[Not yet recruiting]
Saratov, Russian Federation, 410012
[Not yet recruiting]
St. Petersburg, Russian Federation, 197022
[Not yet recruiting]
St. Petersburg, Russian Federation, 197758
[Not yet recruiting]
Tyumen, Russian Federation, 625041
[Not yet recruiting]
Volgograd, Russian Federation, 400138
Serbia
[Not yet recruiting]
Belgrade, Serbia, 11000
[Not yet recruiting]
Belgrade, Serbia, 11080
[Not yet recruiting]
Kragujevac, Serbia, 34000
Slovakia
[Recruiting]
Bratislava, Slovakia, 833 05
[Not yet recruiting]
Bratislava, Slovakia, 85101
[Not yet recruiting]
Martin, Slovakia, 036 59
[Not yet recruiting]
Presov, Slovakia, 080 81
[Not yet recruiting]
Skalica, Slovakia, 90982
[Not yet recruiting]
Trencin, Slovakia, 91101
South Africa
[Not yet recruiting]
Cape Town, South Africa, 7505
[Recruiting]
Cape Town, South Africa, 7925
South Africa, Eastern Cape
[Recruiting]
George, Eastern Cape, South Africa, 6530
[Recruiting]
Port Elizabeth, Eastern Cape, South Africa, 6045
South Africa, Gauteng
[Not yet recruiting]
Johannesburg, Gauteng, South Africa, 2193
[Recruiting]
Pretoria, Gauteng, South Africa, 0083
South Africa, Kwazulu-Natal
[Not yet recruiting]
Durban, Kwazulu-Natal, South Africa, 4126
South Africa, Western Cape
[Not yet recruiting]
Paarl, Western Cape, South Africa, 7646
[Recruiting]
Rondebosch, Western Cape, South Africa, 7700
[Not yet recruiting]
Somerset West, Western Cape, South Africa, 7130
Spain
[Not yet recruiting]
Barcelona, Spain, 08025
[Not yet recruiting]
Barcelona, Spain, 08035
[Not yet recruiting]
Barcelona, Spain, 08036
[Not yet recruiting]
Bilbao, Spain, 48013
[Not yet recruiting]
Córdoba, Spain, 14004
[Not yet recruiting]
Granada, Spain, 18003
[Not yet recruiting]
Granada, Spain, 18014
[Not yet recruiting]
Lugo, Spain, 27003
[Not yet recruiting]
Madrid, Spain, 28007
[Not yet recruiting]
Madrid, Spain, 28040
[Not yet recruiting]
Madrid, Spain, 28041
[Not yet recruiting]
Madrid, Spain, 28046
[Not yet recruiting]
Madrid, Spain, 28050
[Not yet recruiting]
Pamplona, Spain, 31008
[Not yet recruiting]
Salamanca, Spain, 37007
[Recruiting]
Sevilla, Spain, 41013
[Not yet recruiting]
Sevilla, Spain, 41071
[Not yet recruiting]
Valencia, Spain, 46009
[Not yet recruiting]
Valencia, Spain, 46015
[Terminated]
Valencia, Spain, 46026
[Not yet recruiting]
Valencia, Spain, 46026
Spain, Alicante
[Recruiting]
Elche, Alicante, Spain, 03203
Spain, Andalucía
[Not yet recruiting]
Cádiz, Andalucía, Spain, 11009
Spain, Barcelona
[Not yet recruiting]
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
[Not yet recruiting]
Sabadell, Barcelona, Spain, 08208
[Not yet recruiting]
Terrassa, Barcelona, Spain, 08221
Spain, Illes Baleares
[Not yet recruiting]
Manacor, Illes Baleares, Spain
[Not yet recruiting]
Palma de Mallorca, Illes Baleares, Spain, 07010
Spain, Madrid
[Not yet recruiting]
Alcorcón, Madrid, Spain, 28922
[Not yet recruiting]
Fuenlabrada, Madrid, Spain, 28942
Spain, Vizcaya
[Terminated]
Barakaldo, Vizcaya, Spain, 48903
Sweden
[Not yet recruiting]
Borås, Sweden, 501 82
[Not yet recruiting]
Göteborg, Sweden, 413 45
[Recruiting]
Stockholm, Sweden, 171 76
[Recruiting]
Uppsala, Sweden, 751 85
[Not yet recruiting]
Örebro, Sweden, 701 85
Taiwan
[Recruiting]
Kaohsiung City ,, Taiwan
[Not yet recruiting]
Kaoshiung, Taiwan, 813
[Not yet recruiting]
Taichung, Taiwan, 40705
[Not yet recruiting]
Taipei, Taiwan, 100
Turkey
[Not yet recruiting]
Ankara, Turkey, 06500
[Not yet recruiting]
Ankara, Turkey
[Not yet recruiting]
Istanbul, Turkey, 34730
[Not yet recruiting]
Izmir, Turkey, 35100
[Not yet recruiting]
Izmir, Turkey
[Not yet recruiting]
Manisa, Turkey, 45010
[Not yet recruiting]
Sivas, Turkey, 58140
Ukraine
[Not yet recruiting]
Chernivtsi, Ukraine, 58002
[Recruiting]
Dnipropetrovsk, Ukraine, 49102
[Recruiting]
Kharkiv, Ukraine, 61037
[Not yet recruiting]
Kryvyi Rih, Ukraine, 50048
[Recruiting]
Kyiv, Ukraine, 252053
[Not yet recruiting]
Kyiv, Ukraine, 2660
[Recruiting]
Uzhgorod, Ukraine, 88014
[Not yet recruiting]
Zaporozhye, Ukraine, 69600
United Kingdom
[Not yet recruiting]
Cardiff, United Kingdom, CF14 4XN
[Recruiting]
Llanelli, United Kingdom, SA14 8QF
[Not yet recruiting]
London, United Kingdom, SW17 0QT
[Not yet recruiting]
London, United Kingdom, SW3 6JJ
[Not yet recruiting]
Wrexham, United Kingdom, LL13 7TD
United Kingdom, Berkshire
[Not yet recruiting]
Reading, Berkshire, United Kingdom, RG1 5AN
United Kingdom, Essex
[Not yet recruiting]
Romford, Essex, United Kingdom, RM7 0AG
United Kingdom, Hertfordshire
[Not yet recruiting]
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
United Kingdom, Kent
[Not yet recruiting]
Maidstone, Kent, United Kingdom, ME16 9QQ
United Kingdom, Lancashire
[Recruiting]
Preston, Lancashire, United Kingdom, PR2 4HT
United Kingdom, Merseyside
[Recruiting]
Bebington, Merseyside, United Kingdom, CH63 4JY
United Kingdom, North East Lincolnshire
[Not yet recruiting]
Scunthorpe, North East Lincolnshire, United Kingdom, DN15 7BH
United Kingdom, Tayside
[Not yet recruiting]
Dundee, Tayside, United Kingdom, DD2 1UB
United Kingdom, West Midlands
[Not yet recruiting]
Dudley, West Midlands, United Kingdom, DY1 2HQ
United Kingdom, West Yorkshire
[Not yet recruiting]
Huddersfield, West Yorkshire, United Kingdom, HD3 3EA
[Not yet recruiting]
Wakefield, West Yorkshire, United Kingdom, WF1 4DG
United Kingdom, Worcestershire
[Not yet recruiting]
Worcester, Worcestershire, United Kingdom, WR5 1DD
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