A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities
This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01715818
First received: October 25, 2012
Last updated: June 18, 2013
Last verified: June 2013
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Purpose
This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or matching placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease, Diabetes Mellitus, Type 2 |
Drug: aleglitazar Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Time to first occurrence of any component of the composite event (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke) as adjudicated by the Clinical Events Committee (CEC) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to first occurrence of a composite with components as adjudicated by the CEC: cardiovascular death, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Time to first occurrence of a composite with components as adjudicated by the CEC: all-cause mortality, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 19000 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | February 2018 |
| Estimated Primary Completion Date: | February 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Aleglitazar |
Drug: aleglitazar
150 mcg orally daily
|
| Placebo Comparator: Placebo |
Drug: Placebo
matching aleglitazar placebo tablet orally daily
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female patients with established evidence of stable cardiovascular disease (CVD) defined as at least one of the following groups of criteria (A or B) A. Age >/= 40 years with history with prior CV event of prior myocardial infarction or prior ischemic stroke (confirmed by brain imaging study), with onset >/= 3 months prior to randomization and stable in the Investigator's judgment B. Age >/= 55 years with evidence of CVD (stable in the Investigator's judgment), defined as at least one of the following: Coronary disease, cerebrovascular disease or peripheral arterial disease as defined by protocol
- Patients with glucose abnormalities based on one of the following A-B criteria:
A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities
- Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines
Exclusion Criteria:
- Current treatment with a thiazolidinedione (TDZ) or fibrate
- Prior intolerance to a TDZ or fibrate
- Previous participation in a trial with aleglitazar
- Other types of diabetes
- Inadequate liver, hematologic or renal function
- Symptomatic heart failure classified as NYHA class II-IV
- Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding randomization
- Peripheral edema which in the judgment of the Investigator in believed to be severe and of cardiac origin
- History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction
- Currently scheduled for arterial revascularization procedures
- Systemic corticosteroid therapy for > 2 weeks within 3 months prior to screening
- Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715818
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Contacts
| Contact: Reference Study ID Number: BC28027 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global.rochegenentechtrials@roche.com |
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| Cudahy, California, United States, 90201 | |
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| Encino, California, United States, 91436 | |
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| Foothill Ranch, California, United States, 92610 | |
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| Fresno, California, United States, 93720 | |
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| Fresno, California, United States, 93721 | |
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| Hawaiian Gardens, California, United States, 90716 | |
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| Huntington Beach, California, United States, 92646 | |
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| Akron, Ohio, United States, 44313 | |
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| Dakota Dunes, South Dakota, United States, 57049 | |
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| Chattanooga, Tennessee, United States, 37411 | |
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| Jackson, Tennessee, United States, 38305 | |
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| Arlington, Texas, United States, 76012 | |
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| Houston, Texas, United States, 77036 | |
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| New Braunfels, Texas, United States, 78130 | |
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| North Richland Hills, Texas, United States, 76180 | |
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| San Antonio, Texas, United States, 78224 | |
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| San Antonio, Texas, United States, 78229 | |
| Terminated | |
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| Buenos Aires, Argentina, C1155ADP | |
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| Caba, Argentina, C1119ACN | |
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| Caba, Argentina, C1428DCO | |
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| Corrientes, Argentina, W3400AMZ | |
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| La Plata, Argentina, 1900 | |
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| Mendoza, Argentina, 5500 | |
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| Australia, New South Wales | |
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| Camperdown, New South Wales, Australia, 2050 | |
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| Gosford, New South Wales, Australia, 2250 | |
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| Kogarah, New South Wales, Australia, 2217 | |
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| Wollongong, New South Wales, Australia, 2500 | |
| Australia, Queensland | |
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| Adelaide, South Australia, Australia, 5112 | |
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| Adelaide, South Australia, Australia, 5000 | |
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| Bedford Park, South Australia, Australia, 5042 | |
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| Launceston, Tasmania, Australia, 7250 | |
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| Armadale, Western Australia, Australia, 6112 | |
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| Perth, Western Australia, Australia, 6009 | |
| Austria | |
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| Braunau, Austria, 5280 | |
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| Feldkirch, Austria, 6800 | |
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| Graz, Austria, 8036 | |
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| Wien, Austria, 1130 | |
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| Wien, Austria, 1090 | |
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| Fortaleza, CE, Brazil, 60430-350 | |
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| Fortaleza, CE, Brazil, 60135-170 | |
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| Recife, PE, Brazil, 52020-010 | |
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| Curitiba, PR, Brazil, 80730-150 | |
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| Rio de Janeiro, RJ, Brazil, 20211-340 | |
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| Caxias do Sul, RS, Brazil, 95070-560 | |
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| Porto Alegre, RS, Brazil, 90035-001 | |
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| Porto Alegre, RS, Brazil, 90035-170 | |
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| Porto Alegre, RS, Brazil, 90620001 | |
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| Campinas, SP, Brazil, 13060-803 | |
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| Campinas, SP, Brazil, 13010-001 | |
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| Sao Paulo, SP, Brazil, 05403-000 | |
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| Sao Paulo, SP, Brazil, 04266-010 | |
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| Sarnia, Ontario, Canada, N7T 4X3 | |
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| Toronto, Ontario, Canada, M5G 2C4 | |
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| Toronto, Ontario, Canada, M9V 4B4 | |
| Canada, Prince Edward Island | |
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| Quebec, Prince Edward Island, Canada, G1V 4G2 | |
| Canada, Quebec | |
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| Chicoutimi, Quebec, Canada, G7H 7Y8 | |
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| Chicoutimi, Quebec, Canada, G7H 5H6 | |
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| Lachine, Quebec, Canada, H8S 2E4 | |
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| Laval, Quebec, Canada, H7M 3L9 | |
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| Longueuil, Quebec, Canada, J4M 2X1 | |
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| Montreal, Quebec, Canada, H2P 2M1 | |
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| Montreal, Quebec, Canada, H3G 1A4 | |
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| Montreal, Quebec, Canada, H1T 1C8 | |
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| Montreal, Quebec, Canada, H1T 3Y7 | |
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| Montréal, Quebec, Canada, H4N 2W2 | |
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| Sherbrooke, Quebec, Canada, J1H 5N4 | |
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| St-Charles Borromee, Quebec, Canada, J6E 6J2 | |
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| St-Lambert, Quebec, Canada, J4P 2H4 | |
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| St. Jerome, Quebec, Canada, J7Z 5T3 | |
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| Ste-Foy, Quebec, Canada, G1W 4R4 | |
| Recruiting | |
| Terrebonne, Quebec, Canada, J6V 1S8 | |
| Canada, Saskatchewan | |
| Recruiting | |
| Saskatoon, Saskatchewan, Canada, S7K 3H3 | |
| Canada | |
| Not yet recruiting | |
| Quebec, Canada, G1V 4G5 | |
| Recruiting | |
| Quebec, Canada, G3K 2P8 | |
| Chile | |
| Not yet recruiting | |
| Las Condes, Chile, 7500710 | |
| Not yet recruiting | |
| Santiago, Chile, 7500010 | |
| Recruiting | |
| Santiago, Chile, 7500710 | |
| Not yet recruiting | |
| Santiago, Chile, 7500347 | |
| Not yet recruiting | |
| Temuco, Chile, 4813299 | |
| Not yet recruiting | |
| Temuco, Chile, 4781156 | |
| Not yet recruiting | |
| Temuco, Chile, 4790869 | |
| Colombia | |
| Recruiting | |
| Barranquila, Colombia | |
| Recruiting | |
| Barranquilla, Colombia | |
| Not yet recruiting | |
| Barranquilla, Colombia | |
| Not yet recruiting | |
| Bogota, Colombia | |
| Recruiting | |
| Bogota, Colombia | |
| Recruiting | |
| Bogotá, Colombia | |
| Not yet recruiting | |
| Bucaramanga, Colombia | |
| Recruiting | |
| Cartagena, Colombia | |
| Recruiting | |
| Floridablanca, Colombia | |
| Not yet recruiting | |
| Medellin, Colombia | |
| Recruiting | |
| Medellin, Colombia | |
| Czech Republic | |
| Recruiting | |
| Beroun, Czech Republic, 266 01 | |
| Recruiting | |
| Brno, Czech Republic, 625 00 | |
| Recruiting | |
| Brno, Czech Republic, 601 77 | |
| Recruiting | |
| Jihlava, Czech Republic, 586 33 | |
| Not yet recruiting | |
| Liberec, Czech Republic, 460 63 | |
| Recruiting | |
| Praha, Czech Republic, 150 30 | |
| Recruiting | |
| Praha 10, Czech Republic, 100 34 | |
| Not yet recruiting | |
| Praha 2, Czech Republic, 128 08 | |
| Recruiting | |
| Praha 4, Czech Republic, 149 00 | |
| Recruiting | |
| Praha 4, Czech Republic, 140 59 | |
| Recruiting | |
| Praha 4, Czech Republic, 140 21 | |
| Recruiting | |
| Praha 4 - Krc, Czech Republic, 140 59 | |
| Recruiting | |
| Praha 5, Czech Republic, 158 00 | |
| Recruiting | |
| Praha 5, Czech Republic, 150 06 | |
| Recruiting | |
| Slany, Czech Republic, 274 51 | |
| Recruiting | |
| Trebic, Czech Republic, 674 01 | |
| Estonia | |
| Recruiting | |
| Narva, Estonia, 20307 | |
| Not yet recruiting | |
| Tallinn, Estonia, 11313 | |
| Recruiting | |
| Tallinn, Estonia, 10138 | |
| Recruiting | |
| Tartu, Estonia, 51014 | |
| Recruiting | |
| Tartu, Estonia, 50410 | |
| Finland | |
| Not yet recruiting | |
| Kokkola, Finland, 67100 | |
| Not yet recruiting | |
| Oulu, Finland, 90220 | |
| Not yet recruiting | |
| Oulu, Finland, 90100 | |
| Not yet recruiting | |
| Seinäjoki, Finland, 60220 | |
| Not yet recruiting | |
| Turku, Finland, 20521 | |
| Not yet recruiting | |
| Vantaa, Finland, 01360 | |
| France | |
| Not yet recruiting | |
| Bondy, France, 93143 | |
| Not yet recruiting | |
| Dijon, France, 21079 | |
| Not yet recruiting | |
| Mantes La Jolie, France, 78200 | |
| Not yet recruiting | |
| Paris, France, 75015 | |
| Not yet recruiting | |
| Poitiers, France, 86000 | |
| Not yet recruiting | |
| Saint Herblain, France, 44800 | |
| Not yet recruiting | |
| Toulouse Cedex 9, France, 31059 | |
| Not yet recruiting | |
| Venissieux, France, 69200 | |
| Germany | |
| Recruiting | |
| Berlin, Germany, 10117 | |
| Recruiting | |
| Berlin, Germany, 13353 | |
| Recruiting | |
| Berlin, Germany, 13125 | |
| Recruiting | |
| Berlin-Charlottenburg, Germany, 14050 | |
| Not yet recruiting | |
| Bochum, Germany, 44787 | |
| Recruiting | |
| Bochum, Germany, 44787 | |
| Not yet recruiting | |
| Burg, Germany, 03096 | |
| Recruiting | |
| Chemnitz, Germany, 09111 | |
| Not yet recruiting | |
| Damme, Germany, 49401 | |
| Not yet recruiting | |
| Dresden, Germany, 01067 | |
| Recruiting | |
| Dresden, Germany, 01067 | |
| Not yet recruiting | |
| Duesseldorf, Germany, 40597 | |
| Not yet recruiting | |
| Essen, Germany, 45359 | |
| Not yet recruiting | |
| Falkensee, Germany, 14612 | |
| Recruiting | |
| Frankfurt, Germany, 65929 | |
| Recruiting | |
| Frankfurt, Germany, 60596 | |
| Not yet recruiting | |
| Fulda, Germany, 36037 | |
| Not yet recruiting | |
| Hannover, Germany, 30159 | |
| Not yet recruiting | |
| Homburg, Germany, 66421 | |
| Recruiting | |
| Kassel, Germany, 34121 | |
| Recruiting | |
| Koethen, Germany, 06366 | |
| Recruiting | |
| Köln, Germany, 50937 | |
| Recruiting | |
| Leipzig, Germany, 04103 | |
| Recruiting | |
| Magdeburg, Germany, 39104 | |
| Not yet recruiting | |
| Mainz, Germany, 55131 | |
| Not yet recruiting | |
| Mainz, Germany, 55116 | |
| Not yet recruiting | |
| Mannheim, Germany, 68165 | |
| Not yet recruiting | |
| Moenchengladbach, Germany, 41063 | |
| Recruiting | |
| Münster, Germany, 48145 | |
| Recruiting | |
| Neunkirchen, Germany, 66539 | |
| Recruiting | |
| Oldenburg, Germany, 26135 | |
| Recruiting | |
| Wangen, Germany, 88239 | |
| Hungary | |
| Recruiting | |
| Balatonfuered, Hungary, 8230 | |
| Not yet recruiting | |
| Budapest, Hungary, 1083 | |
| Recruiting | |
| Budapest, Hungary, 1036 | |
| Not yet recruiting | |
| Budapest, Hungary, 1085 | |
| Recruiting | |
| Budapest, Hungary, 1196 | |
| Recruiting | |
| Budapest, Hungary, 1125 | |
| Not yet recruiting | |
| Budapest, Hungary, 1027 | |
| Not yet recruiting | |
| Budapest, Hungary, 1122 | |
| Not yet recruiting | |
| Budapest, Hungary, 1106 | |
| Recruiting | |
| Budapest, Hungary, 1131 | |
| Not yet recruiting | |
| Budapest, Hungary, 1212 | |
| Not yet recruiting | |
| Budapest, Hungary, 1096 | |
| Not yet recruiting | |
| Budapest, Hungary, 1023 | |
| Recruiting | |
| Debrecen, Hungary, 4032 | |
| Recruiting | |
| Gyöngyös, Hungary, 3200 | |
| Recruiting | |
| Mosonmagyarovar, Hungary, 9200 | |
| Recruiting | |
| Nyíregyháza, Hungary, 4400 | |
| Recruiting | |
| Papa, Hungary, 8500 | |
| Not yet recruiting | |
| Pecs, Hungary, 7623 | |
| Not yet recruiting | |
| Szeged, Hungary, 6720 | |
| Not yet recruiting | |
| Szekesfehervar, Hungary, 8000 | |
| Recruiting | |
| Szolnok, Hungary, 5004 | |
| Recruiting | |
| Zalaegerszeg, Hungary, 8900 | |
| India | |
| Not yet recruiting | |
| Ahmedabad, India, 700017 | |
| Not yet recruiting | |
| Ahmedabad, India, 380006 | |
| Not yet recruiting | |
| Ahmedabad, India, 380060 | |
| Not yet recruiting | |
| Aurangabad, India, 431005 | |
| Not yet recruiting | |
| Bangalore, India, 560043 | |
| Not yet recruiting | |
| Bangalore, India, 560052 | |
| Not yet recruiting | |
| Bangalore, India, 560010 | |
| Not yet recruiting | |
| Bangalore, India, 560085 | |
| Not yet recruiting | |
| Bangalore, India, 560034 | |
| Not yet recruiting | |
| Bangalore, India, 562114 | |
| Not yet recruiting | |
| Cochin, India, 682041 | |
| Not yet recruiting | |
| Coimbatore, India, 641009 | |
| Not yet recruiting | |
| Gurgaon, India, 122001 | |
| Not yet recruiting | |
| Hyderabad, India, 500001 | |
| Not yet recruiting | |
| Hyderabad, India, 500034 | |
| Not yet recruiting | |
| Hyderabad, India, 500004 | |
| Not yet recruiting | |
| Hyderabad, India, 500063 | |
| Not yet recruiting | |
| Jaipur, India, 302001 | |
| Not yet recruiting | |
| Jalandhar, India, 144008 | |
| Not yet recruiting | |
| Kolkata, India, 700020 | |
| Not yet recruiting | |
| Kota, India, 324005 | |
| Not yet recruiting | |
| Lucknow, India, 226003 | |
| Not yet recruiting | |
| Madurai, India, 625020 | |
| Not yet recruiting | |
| Mangalore, India, 575004 | |
| Not yet recruiting | |
| Mumbai, India, 400012 | |
| Not yet recruiting | |
| Mysore, India, 570020 | |
| Not yet recruiting | |
| Nagpur, India, 440012 | |
| Not yet recruiting | |
| Nagpur, India, 440033 | |
| Not yet recruiting | |
| Nagpur, India, 440017 | |
| Not yet recruiting | |
| Nagpur, India, 440008 | |
| Not yet recruiting | |
| Nashik, India, 422005 | |
| Not yet recruiting | |
| Nasik, India, 422005 | |
| Not yet recruiting | |
| Nasik, India, 422002 | |
| Not yet recruiting | |
| New Delhi, India, 110007 | |
| Not yet recruiting | |
| New Delhi, India, 110060 | |
| Not yet recruiting | |
| Pune, India, 411001 | |
| Not yet recruiting | |
| Pune, India, 411019 | |
| Not yet recruiting | |
| Pune, India, 411033 | |
| Not yet recruiting | |
| Pune, India, 411007 | |
| Not yet recruiting | |
| Pune, India, 411030 | |
| Not yet recruiting | |
| Tondiarpet, India, 600081 | |
| Indonesia | |
| Not yet recruiting | |
| Denpasar, Indonesia, 80114 | |
| Not yet recruiting | |
| Jakarta, Indonesia, 13630 | |
| Not yet recruiting | |
| Jawa Tengah, Indonesia, 50244 | |
| Not yet recruiting | |
| Malang, Indonesia, 65111 | |
| Not yet recruiting | |
| Surabaya, Indonesia, 60286 | |
| Not yet recruiting | |
| Yogyakarta, Indonesia, 55284 | |
| Israel | |
| Not yet recruiting | |
| Afula, Israel, 18101 | |
| Not yet recruiting | |
| Beer Sheba, Israel | |
| Not yet recruiting | |
| Givatayim, Israel, 53583 | |
| Not yet recruiting | |
| Haifa, Israel, 31096 | |
| Not yet recruiting | |
| Haifa, Israel, 34362 | |
| Not yet recruiting | |
| Holon, Israel, 58100 | |
| Not yet recruiting | |
| Jerusalem, Israel, 91031 | |
| Not yet recruiting | |
| Kfar Saba, Israel, 44281 | |
| Not yet recruiting | |
| Nahariya, Israel, 22100 | |
| Not yet recruiting | |
| Petach Tikva, Israel, 49582 | |
| Not yet recruiting | |
| Petach Tikva, Israel, 49100 | |
| Not yet recruiting | |
| Ramat Gan, Israel, 52621 | |
| Not yet recruiting | |
| Ranana, Israel, 43451 | |
| Not yet recruiting | |
| Rehovot, Israel, 76100 | |
| Not yet recruiting | |
| Tel Aviv, Israel, 64239 | |
| Not yet recruiting | |
| Tel-Aviv, Israel, 62038 | |
| Not yet recruiting | |
| Zefat, Israel, 13100 | |
| Italy | |
| Not yet recruiting | |
| Bergamo, Italy, 24128 | |
| Recruiting | |
| Bologna, Italy, 40133 | |
| Recruiting | |
| Catania, Italy, 95122 | |
| Not yet recruiting | |
| Cona (Ferrara), Italy, 44124 | |
| Not yet recruiting | |
| Genova, Italy, 16132 | |
| Not yet recruiting | |
| Latina, Italy, 04100 | |
| Recruiting | |
| Massa, Italy, 54100 | |
| Recruiting | |
| Milano, Italy, 20132 | |
| Recruiting | |
| Milano, Italy, 20138 | |
| Recruiting | |
| Naples, Italy, 80122 | |
| Not yet recruiting | |
| Napoli, Italy, 80131 | |
| Recruiting | |
| Napoli, Italy, 80131 | |
| Recruiting | |
| Palermo, Italy, 90127 | |
| Not yet recruiting | |
| Pavia, Italy, 27100 | |
| Recruiting | |
| Pesaro, Italy, 61121 | |
| Not yet recruiting | |
| Roma, Italy, 00135 | |
| Not yet recruiting | |
| Roma, Italy, 00128 | |
| Recruiting | |
| Rome, Italy, 00185 | |
| Japan | |
| Recruiting | |
| Tochigi, Japan, 329-0498 | |
| Korea, Republic of | |
| Recruiting | |
| Busan, Korea, Republic of, 602-715 | |
| Recruiting | |
| Busan, Korea, Republic of, 602-739 | |
| Recruiting | |
| Daejeon, Korea, Republic of, 301-721 | |
| Recruiting | |
| Goyang, Korea, Republic of | |
| Recruiting | |
| Goyang-si, Korea, Republic of, 411-706 | |
| Recruiting | |
| Gwang Ju, Korea, Republic of, 501-757 | |
| Recruiting | |
| Gyeonggi-do, Korea, Republic of, 431-070 | |
| Recruiting | |
| Incheon, Korea, Republic of, 405-760 | |
| Recruiting | |
| Seoul, Korea, Republic of, 143-729 | |
| Not yet recruiting | |
| Seoul, Korea, Republic of, 133-792 | |
| Recruiting | |
| Seoul, Korea, Republic of, 156-707 | |
| Recruiting | |
| Seoul, Korea, Republic of, 135-720 | |
| Recruiting | |
| Seoul, Korea, Republic of, 137-701 | |
| Recruiting | |
| Seoul, Korea, Republic of, 130-872 | |
| Recruiting | |
| Suwon City, Korea, Republic of, 443-721 | |
| Recruiting | |
| Suwon-si,, Korea, Republic of, 442-723 | |
| Recruiting | |
| Uijeongbu-si, Korea, Republic of, 480-717 | |
| Recruiting | |
| Wonju, Korea, Republic of, 220-701 | |
| Latvia | |
| Not yet recruiting | |
| Daugavpils, Latvia, LV 5417 | |
| Recruiting | |
| Liepaja, Latvia, 3400 | |
| Not yet recruiting | |
| Riga, Latvia, LV-1058 | |
| Not yet recruiting | |
| Riga, Latvia, LV-1002 | |
| Not yet recruiting | |
| Riga, Latvia, LV 1002 | |
| Not yet recruiting | |
| Riga, Latvia, LV-1024 | |
| Not yet recruiting | |
| Riga, Latvia, LV-1012 | |
| Not yet recruiting | |
| Talsi, Latvia, LV-3200 | |
| Not yet recruiting | |
| Valmiera, Latvia, 4201 | |
| Lithuania | |
| Recruiting | |
| Kaunas, Lithuania, LT-47144 | |
| Not yet recruiting | |
| Kaunas, Lithuania, 50009 | |
| Recruiting | |
| Kaunas, Lithuania, 48259 | |
| Recruiting | |
| Kaunas, Lithuania, 50184 | |
| Not yet recruiting | |
| Vilnius, Lithuania, 08661 | |
| Recruiting | |
| Vilnius, Lithuania, LT-02169 | |
| Malaysia | |
| Recruiting | |
| Johor, Malaysia, 80100 | |
| Not yet recruiting | |
| Kelantan, Malaysia, 16150 | |
| Recruiting | |
| Kuala Lumpur, Malaysia, 59100 | |
| Not yet recruiting | |
| Penang, Malaysia, 10400 | |
| Not yet recruiting | |
| Penang, Malaysia, 10050 | |
| Recruiting | |
| Perak, Malaysia, 34000 | |
| Recruiting | |
| Sabah, Malaysia, 88300 | |
| Recruiting | |
| Sarawak, Malaysia, 94300 | |
| Recruiting | |
| Selangor, Malaysia, 68100 | |
| Mexico | |
| Recruiting | |
| Aguascalientes, Mexico, 20234 | |
| Not yet recruiting | |
| Cuernavaca, Mexico, 62250 | |
| Not yet recruiting | |
| Guadalajara, Mexico, 44340 | |
| Not yet recruiting | |
| Merida, Mexico, 97070 | |
| Recruiting | |
| Mexico, Mexico, 03300 | |
| Not yet recruiting | |
| Mexico City, Mexico, 14000 | |
| Not yet recruiting | |
| Mexico City, Mexico, 11850 | |
| Recruiting | |
| Monclova, Mexico, 25750 | |
| Recruiting | |
| Monterrey, Mexico, 64460 | |
| Not yet recruiting | |
| Monterrey, Mexico, 64620 | |
| Not yet recruiting | |
| Oaxaca, Mexico, 68000 | |
| Not yet recruiting | |
| Queretaro, Mexico, 76000 | |
| Not yet recruiting | |
| San Luis Potosí, Mexico, 78200 | |
| Not yet recruiting | |
| San Luís Potosí, Mexico, 78200 | |
| Not yet recruiting | |
| Tijuana, Mexico, 22010 | |
| Recruiting | |
| Xalapa, Mexico, 91020 | |
| Not yet recruiting | |
| Zapopan, Mexico, 45200 | |
| Peru | |
| Not yet recruiting | |
| Arequipa, Peru, 04001 | |
| Not yet recruiting | |
| Callao, Peru, Callao 02 | |
| Not yet recruiting | |
| Cusco, Peru, 08006 | |
| Not yet recruiting | |
| Lima, Peru, 18 | |
| Not yet recruiting | |
| Lima, Peru, Lima 41 | |
| Not yet recruiting | |
| Lima, Peru, 31 | |
| Not yet recruiting | |
| Lima, Peru, Lima 27 | |
| Not yet recruiting | |
| Lima, Peru, 33 | |
| Not yet recruiting | |
| Lima, Peru | |
| Not yet recruiting | |
| Lince, Peru, Lima 14 | |
| Not yet recruiting | |
| Magdalena del Mar, Peru, Lima 17 | |
| Not yet recruiting | |
| Piura, Peru, 20001 | |
| Not yet recruiting | |
| San Isidro, Peru, 27 | |
| Not yet recruiting | |
| San Miguel, Peru, Lima 32 | |
| Philippines | |
| Not yet recruiting | |
| CEBU City, Philippines, 6000 | |
| Not yet recruiting | |
| Dasmariñas Cavite City, Philippines, 4114 | |
| Not yet recruiting | |
| Davao City, Philippines, 8000 | |
| Not yet recruiting | |
| Iloilo City, Philippines, 5000 | |
| Not yet recruiting | |
| Mandaluyong City, Philippines, 1550 | |
| Not yet recruiting | |
| Marikina, Philippines, 1810 | |
| Not yet recruiting | |
| Quezon City, Philippines, 1104 | |
| Not yet recruiting | |
| San Fernando Pampanga, Philippines, 2000 | |
| Not yet recruiting | |
| Surigao City, Philippines, 8400 | |
| Poland | |
| Recruiting | |
| Bialystok, Poland, 15-276 | |
| Recruiting | |
| Gdynia, Poland, 81-472 | |
| Recruiting | |
| Gdynia, Poland, 81-384 | |
| Recruiting | |
| Katowice, Poland, 40-954 | |
| Not yet recruiting | |
| Katowice, Poland, 40-635 | |
| Recruiting | |
| Katowice, Poland, 40-748 | |
| Not yet recruiting | |
| Kielce, Poland, 25-736 | |
| Recruiting | |
| Krakow, Poland, 30-082 | |
| Recruiting | |
| Krakow, Poland, 30-015 | |
| Recruiting | |
| Krakow, Poland, 31-261 | |
| Recruiting | |
| Krakow, Poland, 31-202 | |
| Not yet recruiting | |
| Kutno, Poland, 99-300 | |
| Recruiting | |
| Lodz, Poland, 90-242 | |
| Recruiting | |
| Lublin, Poland, 20-093 | |
| Recruiting | |
| Lublin, Poland, 20-044 | |
| Not yet recruiting | |
| Naleczow, Poland, 20-140 | |
| Recruiting | |
| Nowy Sacz, Poland, 33-300 | |
| Recruiting | |
| Opole, Poland, 45-367 | |
| Recruiting | |
| Rzeszow, Poland, 35-055 | |
| Not yet recruiting | |
| Szczecin, Poland, 71-455 | |
| Not yet recruiting | |
| Szczecin, Poland, 70-111 | |
| Recruiting | |
| Warsawa, Poland, 01-192 | |
| Not yet recruiting | |
| Warszawa, Poland, 04-628 | |
| Not yet recruiting | |
| Warszawa, Poland, 02-097 | |
| Not yet recruiting | |
| Wroclaw, Poland, 50-420 | |
| Recruiting | |
| Wroclaw, Poland, 50-088 | |
| Not yet recruiting | |
| Zielona Gora, Poland, 65-046 | |
| Romania | |
| Not yet recruiting | |
| Baia Mare, Romania, 430123 | |
| Not yet recruiting | |
| Bucharest, Romania, 020125 | |
| Recruiting | |
| Bucharest, Romania, 800578 | |
| Recruiting | |
| Bucharest, Romania, 061119 | |
| Not yet recruiting | |
| Bucharest, Romania, 41915 | |
| Not yet recruiting | |
| Bucharest, Romania, 11172 | |
| Recruiting | |
| Bucharest, Romania, 010507 | |
| Recruiting | |
| Bucuresti, Romania, 010825 | |
| Recruiting | |
| Bucuresti, Romania, 050098 | |
| Recruiting | |
| Bucuresti, Romania, 020359 | |
| Recruiting | |
| Craiova, Romania, 200642 | |
| Not yet recruiting | |
| Lasi, Romania, 700661 | |
| Recruiting | |
| Oradea, Romania, 410169 | |
| Recruiting | |
| Ploiesti, Romania, 100163 | |
| Recruiting | |
| Targu-Mures, Romania, 540124 | |
| Not yet recruiting | |
| Timisoara, Romania, 300041 | |
| Russian Federation | |
| Not yet recruiting | |
| Chelyabinsk, Russian Federation, 454021 | |
| Recruiting | |
| Kemerovo, Russian Federation | |
| Not yet recruiting | |
| Kemerovo, Russian Federation, 650099 | |
| Not yet recruiting | |
| Kursk, Russian Federation, 305035 | |
| Not yet recruiting | |
| Moscow, Russian Federation, 119620 | |
| Not yet recruiting | |
| Moscow, Russian Federation, 121552 | |
| Not yet recruiting | |
| Moscow, Russian Federation, 117036 | |
| Not yet recruiting | |
| S.Petersburg, Russian Federation, 194017 | |
| Recruiting | |
| Saint Petersburg, Russian Federation, 199034 | |
| Not yet recruiting | |
| Saint-Petersburg, Russian Federation, 191015 | |
| Not yet recruiting | |
| Saint-Petersburg, Russian Federation, 197341 | |
| Not yet recruiting | |
| Saint-Petersburg, Russian Federation, 194156 | |
| Not yet recruiting | |
| Saint-Petersburg, Russian Federation, 195426 | |
| Not yet recruiting | |
| Saratov, Russian Federation, 410030 | |
| Not yet recruiting | |
| Saratov, Russian Federation, 410002 | |
| Not yet recruiting | |
| St. Petersburg, Russian Federation, 194291 | |
| Not yet recruiting | |
| St. Petersburg, Russian Federation, 197706 | |
| Not yet recruiting | |
| St. Petersburg, Russian Federation | |
| Not yet recruiting | |
| Tomsk, Russian Federation, 634012 | |
| Not yet recruiting | |
| Tumen, Russian Federation, 625026 | |
| Not yet recruiting | |
| Tumen, Russian Federation, 625023 | |
| Not yet recruiting | |
| Tyumen, Russian Federation, 625023 | |
| Not yet recruiting | |
| Vsevolozhsk, Russian Federation, 188640 | |
| South Africa | |
| Not yet recruiting | |
| Bloemfontein, South Africa, 9301 | |
| Not yet recruiting | |
| Cape Town, South Africa, 7530 | |
| Not yet recruiting | |
| Cape Town, South Africa, 7646 | |
| Not yet recruiting | |
| Cape Town, South Africa, 7505 | |
| Not yet recruiting | |
| Cape Town, South Africa, 7130 | |
| Not yet recruiting | |
| Cape Town, South Africa, 7460 | |
| Not yet recruiting | |
| Centurion, South Africa, 0157 | |
| Not yet recruiting | |
| Durban, South Africa, 4001 | |
| Not yet recruiting | |
| Johannesberg, South Africa, 2193 | |
| Not yet recruiting | |
| Johannesburg, South Africa, 2013 | |
| Not yet recruiting | |
| Midrand, South Africa, 1685 | |
| Not yet recruiting | |
| Port Elizabeth, South Africa, 6014 | |
| Not yet recruiting | |
| Port Elizabeth, South Africa, 6045 | |
| Not yet recruiting | |
| Pretoria, South Africa, 0001 | |
| Not yet recruiting | |
| Pretoria, South Africa, 0103 | |
| Not yet recruiting | |
| Pretoria-West, South Africa, 0183 | |
| Spain | |
| Not yet recruiting | |
| San Juan de Alicante, Alicante, Spain, 3550 | |
| Not yet recruiting | |
| Torrevieja, Alicante, Spain, 03186 | |
| Not yet recruiting | |
| Palma de Mallorca, Islas Baleares, Spain, 07014 | |
| Recruiting | |
| Santiago de Compostela, La Coruña, Spain, 15706 | |
| Not yet recruiting | |
| Santiago de Compostela, La Coruña, Spain, 15706 | |
| Recruiting | |
| Lleida, Lerida, Spain, 25198 | |
| Not yet recruiting | |
| Majadahonda, Madrid, Spain, 28222 | |
| Not yet recruiting | |
| Pozuelo de alarcon, Madrid, Spain, 28223 | |
| Recruiting | |
| Málaga, Malaga, Spain, 29009 | |
| Not yet recruiting | |
| Lorca, Murcia, Spain, 30800 | |
| Recruiting | |
| Seville, Sevilla, Spain, 41009 | |
| Not yet recruiting | |
| Alzira, Valencia, Spain, 46600 | |
| Not yet recruiting | |
| Requena, Valencia, Spain, 46340 | |
| Recruiting | |
| Albacete, Spain, 02006 | |
| Recruiting | |
| Almeria, Spain, 04009 | |
| Not yet recruiting | |
| Almeria, Spain, 04001 | |
| Not yet recruiting | |
| Barcelona, Spain | |
| Recruiting | |
| Barcelona, Spain, 08907 | |
| Recruiting | |
| Barcelona, Spain, 08036 | |
| Recruiting | |
| Barcelona, Spain, 08035 | |
| Recruiting | |
| Barcelona, Spain, 08003 | |
| Recruiting | |
| Girona, Spain, 17007 | |
| Recruiting | |
| Granada, Spain, 18012 | |
| Recruiting | |
| Huelva, Spain, 21005 | |
| Not yet recruiting | |
| La Coruña, Spain, 15006 | |
| Not yet recruiting | |
| Lugo, Spain, 27003 | |
| Not yet recruiting | |
| Madrid, Spain, 28040 | |
| Not yet recruiting | |
| Madrid, Spain, 280146 | |
| Not yet recruiting | |
| Madrid, Spain, 28007 | |
| Recruiting | |
| Madrid, Spain, 41013 | |
| Recruiting | |
| Malaga, Spain, 29006 | |
| Recruiting | |
| Malaga, Spain, 29010 | |
| Not yet recruiting | |
| Tarragona, Spain, 43007 | |
| Not yet recruiting | |
| Valencia, Spain, 46014 | |
| Not yet recruiting | |
| Valladolid, Spain, 47011 | |
| Sweden | |
| Recruiting | |
| Malmö, Sweden, 205 02 | |
| Not yet recruiting | |
| Orebro, Sweden, 70185 | |
| Not yet recruiting | |
| Stockholm, Sweden, 182 88 | |
| Recruiting | |
| Stockholm, Sweden, 171 76 | |
| Recruiting | |
| Stockholm, Sweden, 113 61 | |
| Recruiting | |
| Stockholm, Sweden, 111 35 | |
| Thailand | |
| Not yet recruiting | |
| Amphur Muang, Thailand, 65000 | |
| Recruiting | |
| Bangkok, Thailand, 10330 | |
| Not yet recruiting | |
| Bangkok, Thailand, 10400 | |
| Not yet recruiting | |
| Bangkok, Thailand, 10700 | |
| Not yet recruiting | |
| Bangkok, Thailand, 10330 | |
| Not yet recruiting | |
| Chiang Mai, Thailand, 50200 | |
| Not yet recruiting | |
| Khon Kaen, Thailand, 40002 | |
| Not yet recruiting | |
| Nakhon Ratchasima, Thailand, 30000 | |
| Not yet recruiting | |
| Pathumthani, Thailand, 12120 | |
| Ukraine | |
| Not yet recruiting | |
| Cherkassy, Ukraine, 18009 | |
| Not yet recruiting | |
| Donetsk, Ukraine, 83059 | |
| Not yet recruiting | |
| Donetsk, Ukraine, 83045 | |
| Not yet recruiting | |
| Ivano-Frankivsk, Ukraine, 76000 | |
| Not yet recruiting | |
| Ivano-Frankivsk, Ukraine, 76025 | |
| Not yet recruiting | |
| Kharkiv, Ukraine, 61039 | |
| Not yet recruiting | |
| Kharkiv, Ukraine, 61000 | |
| Not yet recruiting | |
| Kharkiv, Ukraine, 61124 | |
| Not yet recruiting | |
| Kiev, Ukraine, 04053 | |
| Not yet recruiting | |
| Kiev, Ukraine, 03115 | |
| Not yet recruiting | |
| Kyiv, Ukraine, 02094 | |
| Not yet recruiting | |
| Kyiv, Ukraine, 02002 | |
| Not yet recruiting | |
| Kyiv, Ukraine, 04114 | |
| Not yet recruiting | |
| Kyiv, Ukraine, 03680 | |
| Not yet recruiting | |
| Lutsk, Ukraine, 43024 | |
| Not yet recruiting | |
| Lviv, Ukraine, 79015 | |
| Not yet recruiting | |
| Odessa, Ukraine, 65010 | |
| Not yet recruiting | |
| Ternopil, Ukraine, 46002 | |
| Not yet recruiting | |
| Uzhgorod, Ukraine, 88009 | |
| Not yet recruiting | |
| Valky, Ukraine, 63000 | |
| United Kingdom | |
| Not yet recruiting | |
| Antrim, United Kingdom, BT41 2RL | |
| Not yet recruiting | |
| Bexhill on Sea, United Kingdom | |
| Recruiting | |
| Birmingham, United Kingdom, B15 2SQ | |
| Not yet recruiting | |
| Bournemouth, United Kingdom, BH7 7DW | |
| Not yet recruiting | |
| Bradford on Avon, United Kingdom, BA15 1DQ | |
| Not yet recruiting | |
| Calow, United Kingdom, Chesterfield | |
| Recruiting | |
| Cardiff, United Kingdom, CF14 5GJ | |
| Not yet recruiting | |
| Chesterfield, United Kingdom, S40 4TF | |
| Recruiting | |
| Chorley, United Kingdom, PR7 7NA | |
| Not yet recruiting | |
| Cottingham, United Kingdom, HU16 5JQ | |
| Not yet recruiting | |
| Edinburgh, United Kingdom, EH16 4TJ | |
| Not yet recruiting | |
| Frome, United Kingdom, BA11 1EZ | |
| Not yet recruiting | |
| Glasgow, United Kingdom, G12 8QQ | |
| Recruiting | |
| Glasgow, United Kingdom, G20 0SP | |
| Not yet recruiting | |
| Glasgow, United Kingdom, G12 8TA | |
| Not yet recruiting | |
| Harrow, United Kingdom, HA1 3UJ | |
| Recruiting | |
| Inverness, United Kingdom, IV2 4AG | |
| Not yet recruiting | |
| Ipswich, United Kingdom, IP4 5PD | |
| Not yet recruiting | |
| Isle of Wight, United Kingdom, 30 5TG. | |
| Recruiting | |
| Liverpool, United Kingdom, L22 0LG | |
| Not yet recruiting | |
| Liverpool, United Kingdom, L9 7AL | |
| Recruiting | |
| Manchester, United Kingdom, M15 6SX | |
| Recruiting | |
| Mortimer, United Kingdom, RG7 3SQ | |
| Not yet recruiting | |
| Newcastle upon Tyne, United Kingdom, NE7 7DN | |
| Recruiting | |
| Reading, United Kingdom, RG2 0TG | |
| Not yet recruiting | |
| Soham, Ely, United Kingdom, CB7 5JD | |
| Not yet recruiting | |
| Stoke-on-Trent, United Kingdom | |
| Not yet recruiting | |
| Wakefield, United Kingdom, WF1 4DG | |
| Not yet recruiting | |
| Wellingborough, United Kingdom, NN8 4RW | |
| Not yet recruiting | |
| Worcester, United Kingdom, WR5 1DD | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01715818 History of Changes |
| Other Study ID Numbers: | BC28027, 2012-000671-16 |
| Study First Received: | October 25, 2012 |
| Last Updated: | June 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Congenital Abnormalities Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013