Last updated: 07/17/2024 16:45:29
Effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular events in subjects with Type 2 diabetes mellitus
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A long term, randomised, double blind, placebo-controlled study to determine the effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular events in patients with Type 2 diabetes mellitus
Trial description: Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Time to first occurrence of major adverse cardiovascular events (MACE; cardiovascular death, myocardial infarction, or stroke) [Non-inferiority]
Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.
Secondary outcomes:
Time to first occurrence of MACE [Superiority]
Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.
Time to first occurrence of MACE or urgent revascularisation for unstable angina
Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.
Time to first occurrence of the individual components of the primary endpoint
Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.
Time to first occurrence of cardiovascular death or hospitalization due to heart failure
Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.
All cause mortality
Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.
Time to initiation of insulin of more than 3 months duration for those subjects not treated with insulin at study start
Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.
The proportion of subjects achieving glycemic control (HbA1c <=7.0% at final assessment) with no severe hypoglycemic incidents and weight gain <5% of body weight
Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.
Interventions:
Enrollment:
9463
Primary completion date:
2018-20-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
John McMurray, Stefano Del Prato, Adrian Hernandez, Larry Leiter, Chris Granger, Ralph D’Agostino, Jennifer Green, Kristina Sigmon, Anne Rosenberg Nigel Jones, Karl Thorpe, Matt Somerville, Salim Janmohamed .Albiglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Cardiovascular Disease.Lancet.2018;392(10157):1519-1529
DOI: http://dx.doi.org/10.1016/S0140-6736(18)32261-X
Medical condition
Diabetes Mellitus
Product
albiglutide
Collaborators
Duke Clinical Research Institute
Study date(s)
July 2015 to March 2018
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
- Diagnosis of type 2 diabetes.
- Severely reduced kidney function: eGFR <30 ml/min/1.73 m^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
- Use of a GLP-1 receptor agonist at Screening.
Inclusion and exclusion criteria
Inclusion criteria:
- Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
- Diagnosis of type 2 diabetes.
- Established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
- HbA1c >7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).
- Able and willing to provide informed consent.
Exclusion criteria:
- Severely reduced kidney function: eGFR <30 ml/min/1.73 m^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
- Use of a GLP-1 receptor agonist at Screening.
- Severe gastroparesis
- History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.
- Personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic neuroendocrine tumours.
- Medical history which might limit the subject’s ability to take trial treatments for the duration of the study or to otherwise complete the study.
- Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.
- Known allergy to any GLP-1 receptor agonist or excipients of albiglutide.
- Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
- Any other reason the investigator deems the subject to be unsuitable for the study.
Trial location(s)
Location
GSK Investigational Site
Adrogue, Buenos Aires, Argentina, B1846DSK
Status
Study Complete
Location
GSK Investigational Site
Aguascalientes, Ags, Aguascalientes, Mexico, 20127
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87102
Status
Study Complete
Location
GSK Investigational Site
Anderson, South Carolina, United States, 29621
Status
Study Complete
Location
GSK Investigational Site
Annapolis, Maryland, United States, 21401
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76014
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30318
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Aurora, Illinois, United States, 60504
Status
Study Complete
Location
GSK Investigational Site
Axbridge, Somerset, United Kingdom, BS26 2BJ
Status
Study Complete
Location
GSK Investigational Site
Bad Kreuznach, Rheinland-Pfalz, Germany, 55545
Status
Study Complete
Location
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Status
Study Complete
Location
GSK Investigational Site
Bahia Blanca, Buenos Aires, Argentina, B8000FTD
Status
Study Complete
Location
GSK Investigational Site
Belle Glade, Florida, United States, 33430
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35211
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35235
Status
Study Complete
Location
GSK Investigational Site
Bloemfontein, Free State, South Africa, 9301
Status
Study Complete
Location
GSK Investigational Site
Boadilla del Monte (Madrid), Spain, 28660
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44869
Status
Study Complete
Location
GSK Investigational Site
Bradenton, Florida, United States, 34201
Status
Study Complete
Location
GSK Investigational Site
Bradenton, Florida, United States, 34209
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11215
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1061ABD
Status
Study Complete
Location
GSK Investigational Site
Camden, New Jersey, United States, 08103
Status
Study Complete
Location
GSK Investigational Site
Camp Hill, Pennsylvania, United States, 17011
Status
Study Complete
Location
GSK Investigational Site
Canet de Mar - Barcelona, Spain, 08360
Status
Study Complete
Location
GSK Investigational Site
Cangas del Narcea/Asturias, Spain, 33800
Status
Study Complete
Location
GSK Investigational Site
Champaign, Illinois, United States, 61820
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85284
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28277
Status
Study Complete
Location
GSK Investigational Site
Chesterfield, Derbyshire, United Kingdom, S40 4AA
Status
Study Complete
Location
GSK Investigational Site
Chula Vista, California, United States, 91910
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1056ABJ
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1205
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1179AAB
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1128AAF
Status
Study Complete
Location
GSK Investigational Site
Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina, C141AHN
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29223
Status
Study Complete
Location
GSK Investigational Site
Conyers, Georgia, United States, 30094
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Coral Springs, Florida, United States, 33065
Status
Study Complete
Location
GSK Investigational Site
Cumming, Georgia, United States, 30041
Status
Study Complete
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80220
Status
Study Complete
Location
GSK Investigational Site
Dunwoody, Georgia, United States, 30338
Status
Study Complete
Location
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Status
Study Complete
Location
GSK Investigational Site
Elsterwerda, Brandenburg, Germany, 04910
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45136
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45329
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
Falkensee, Brandenburg, Germany, 14612
Status
Study Complete
Location
GSK Investigational Site
Fargo, North Dakota, United States, 58103
Status
Study Complete
Location
GSK Investigational Site
Feasterville, Pennsylvania, United States, 19053
Status
Study Complete
Location
GSK Investigational Site
Federal Way, Washington, United States, 98003
Status
Study Complete
Location
GSK Investigational Site
Fleming Island, Florida, United States, 32003
Status
Study Complete
Location
GSK Investigational Site
Franklin, Indiana, United States, 46131
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Location
GSK Investigational Site
Georgetown, Texas, United States, 78626
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85308
Status
Study Complete
Location
GSK Investigational Site
Godoy Cruz, Mendoza, Argentina, M5501ARP
Status
Study Complete
Location
GSK Investigational Site
Goodyear, Arizona, United States, 85395
Status
Study Complete
Location
GSK Investigational Site
Greenfield, Indiana, United States, 46140
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2G8
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H1
Status
Study Complete
Location
GSK Investigational Site
Gueglingen, Baden-Wuerttemberg, Germany, 74363
Status
Study Complete
Location
GSK Investigational Site
Gurnee, Illinois, United States, 60031
Status
Study Complete
Location
GSK Investigational Site
Haddon Heights, New Jersey, United States, 08035
Status
Study Complete
Location
GSK Investigational Site
Harleysville, Pennsylvania, United States, 19438
Status
Study Complete
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Study Complete
Location
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31139
Status
Study Complete
Location
GSK Investigational Site
Hohenmoelsen, Sachsen-Anhalt, Germany, 06679
Status
Study Complete
Location
GSK Investigational Site
Huntsville, Texas, United States, 77340
Status
Study Complete
Location
GSK Investigational Site
Inverness, Florida, United States, 34452
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Jerichow, Sachsen-Anhalt, Germany, 39319
Status
Study Complete
Location
GSK Investigational Site
Jersey Shore, Pennsylvania, United States, 17740
Status
Study Complete
Location
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76199
Status
Study Complete
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 1V6
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Kleve, Nordrhein-Westfalen, Germany, 47533
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
Lake Worth, Florida, United States, 33467
Status
Study Complete
Location
GSK Investigational Site
Lakeland, Florida, United States, 33805
Status
Study Complete
Location
GSK Investigational Site
Lancaster, California, United States, 93534
Status
Study Complete
Location
GSK Investigational Site
Lansdale, Pennsylvania, United States, 19446
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89086
Status
Study Complete
Location
GSK Investigational Site
Lewiston., Maine, United States, 04240
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40503
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72209
Status
Study Complete
Location
GSK Investigational Site
Littleton, Colorado, United States, 80120
Status
Study Complete
Location
GSK Investigational Site
Littleton, Colorado, United States, 80127
Status
Study Complete
Location
GSK Investigational Site
Lomita, California, United States, 90717
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90807
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90822
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90017
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90073
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40213
Status
Study Complete
Location
GSK Investigational Site
Ludwigsburg, Baden-Wuerttemberg, Germany, 71640
Status
Study Complete
Location
GSK Investigational Site
Ludwigshafen am Rhein, Rheinland-Pfalz, Germany, 67059
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53713
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Study Complete
Location
GSK Investigational Site
Manassas, Virginia, United States, 20109
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, B7600DHK
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38104
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38119
Status
Study Complete
Location
GSK Investigational Site
Moline, Illinois, United States, 61265
Status
Study Complete
Location
GSK Investigational Site
Moncton, New Brunswick, Canada, E1G 1A7
Status
Study Complete
Location
GSK Investigational Site
Monterrey NL, Nuevo León, Mexico, 64718
Status
Study Complete
Location
GSK Investigational Site
Moreno Valley, California, United States, 92555
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48145
Status
Study Complete
Location
GSK Investigational Site
Muncie, Indiana, United States, 47304-5547
Status
Study Complete
Location
GSK Investigational Site
Munster, Indiana, United States, 46321
Status
Study Complete
Location
GSK Investigational Site
Myrtle Beach, South Carolina, United States, 29572
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37212
Status
Study Complete
Location
GSK Investigational Site
Nashville., Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
New Haven, Connecticut, United States, 06511
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
Status
Study Complete
Location
GSK Investigational Site
Newport, Pennsylvania, United States, 17074
Status
Study Complete
Location
GSK Investigational Site
North Massapequa, New York, United States, 11758
Status
Study Complete
Location
GSK Investigational Site
Northridge, California, United States, 91325
Status
Study Complete
Location
GSK Investigational Site
Northwood, Middlesex, United Kingdom, HA6 2RN
Status
Study Complete
Location
GSK Investigational Site
Oakland, California, United States, 94607
Status
Study Complete
Location
GSK Investigational Site
Pawtucket, Rhode Island, United States, 02860
Status
Study Complete
Location
GSK Investigational Site
Penndel, Pennsylvania, United States, 19047
Status
Study Complete
Location
GSK Investigational Site
Pergamino, Buenos Aires, Argentina, B2700CPM
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15240
Status
Study Complete
Location
GSK Investigational Site
Ponte Vedra, Florida, United States, 32081
Status
Study Complete
Location
GSK Investigational Site
Port Charlotte, Florida, United States, 33952
Status
Study Complete
Location
GSK Investigational Site
Port Orange, Florida, United States, 32127
Status
Study Complete
Location
GSK Investigational Site
Pozuelo de Alarcón/Madrid, Spain, 28223
Status
Study Complete
Location
GSK Investigational Site
Rapid City, South Dakota, United States, 57701
Status
Study Complete
Location
GSK Investigational Site
Rapid City, South Dakota, United States, 57702
Status
Study Complete
Location
GSK Investigational Site
Rednitzhembach, Bayern, Germany, 91126
Status
Study Complete
Location
GSK Investigational Site
Rocky Mount, North Carolina, United States, 27804
Status
Study Complete
Location
GSK Investigational Site
Romford, Essex, United Kingdom, RM1 3PJ
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000CVD
Status
Study Complete
Location
GSK Investigational Site
S.Andrea delle Fratte - S. Sisto (PG), Umbria, Italy, 06132
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78258
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92117
Status
Study Complete
Location
GSK Investigational Site
San Giovanni Rotondo (FG), Puglia, Italy, 71013
Status
Study Complete
Location
GSK Investigational Site
San Marino, California, United States, 91108
Status
Study Complete
Location
GSK Investigational Site
San Martin de Porres, Lima, Peru, Lima 31
Status
Study Complete
Location
GSK Investigational Site
San Ramon, California, United States, 94583
Status
Study Complete
Location
GSK Investigational Site
Sankt Ingbert, Saarland, Germany, 66386
Status
Study Complete
Location
GSK Investigational Site
Sanlucar de Barrameda - Cádiz, Spain, 11540
Status
Study Complete
Location
GSK Investigational Site
Searcy, Arkansas, United States, 72143
Status
Study Complete
Location
GSK Investigational Site
Sellersville, Pennsylvania, United States, 18960
Status
Study Complete
Location
GSK Investigational Site
Sidcup, Kent, United Kingdom, DA14 6LT
Status
Study Complete
Location
GSK Investigational Site
Simi Valley, California, United States, 93065
Status
Study Complete
Location
GSK Investigational Site
Smiths Falls, Ontario, Canada, K7A 4W8
Status
Study Complete
Location
GSK Investigational Site
Snellville, Georgia, United States, 30078
Status
Study Complete
Location
GSK Investigational Site
Soham, Cambridgeshire, United Kingdom, CB7 5JD
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99208
Status
Study Complete
Location
GSK Investigational Site
Springfield, Ohio, United States, 45504
Status
Study Complete
Location
GSK Investigational Site
St-Charles-Borromée, Québec, Canada, J6E 6J2
Status
Study Complete
Location
GSK Investigational Site
St. Cloud, Minnesota, United States, 56303
Status
Study Complete
Location
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63136
Status
Study Complete
Location
GSK Investigational Site
St. Paul, Minnesota, United States, 55102
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33713
Status
Study Complete
Location
GSK Investigational Site
Sta Coloma de Gramanet (Barcelona), Spain, 08923
Status
Study Complete
Location
GSK Investigational Site
Downey, California, United States, 90241
Status
Study Complete
Location
GSK Investigational Site
Statesville, North Carolina, United States, 28625
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70199
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70378
Status
Study Complete
Location
GSK Investigational Site
Suite 101, Texas, United States, 76132
Status
Study Complete
Location
GSK Investigational Site
Surrey, British Columbia, Canada, V3V 0C6
Status
Study Complete
Location
GSK Investigational Site
Suwon, Kyonggi-do, South Korea, 443-721
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Tongaat, KwaZulu- Natal, South Africa, 4400
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90502
Status
Study Complete
Location
GSK Investigational Site
Trois-Rivieres, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Trowbridge, Wiltshire, United Kingdom, BA14 8LW
Status
Study Complete
Location
GSK Investigational Site
Uherske Hradiste, Czech Republic, 686 01
Status
Study Complete
Location
GSK Investigational Site
Usti nad Labem, Czech Republic, 401 13
Status
Study Complete
Location
GSK Investigational Site
Vero Beach, Florida, United States, 32960
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8R 4R2
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 4A1
Status
Study Complete
Location
GSK Investigational Site
Vigevano (PV), Lombardia, Italy, 27029
Status
Study Complete
Location
GSK Investigational Site
Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78048
Status
Study Complete
Location
GSK Investigational Site
Wangen, Baden-Wuerttemberg, Germany, 88239
Status
Study Complete
Location
GSK Investigational Site
Wardenburg, Niedersachsen, Germany, 26203
Status
Study Complete
Location
GSK Investigational Site
Wellington, Florida, United States, 33449
Status
Study Complete
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Study Complete
Location
GSK Investigational Site
West Des Moines, Iowa, United States, 50265
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
Status
Study Complete
Location
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2018-20-02
Actual study completion date
2018-14-03
Plain language summaries
Summary of results in plain language
Available language(s): English (UK), Greek, Spanish (Argentina), Spanish, Spanish (Mexico), Spanish (Peru), Filipino-Tagalog, French (Belgium), French (Canadian), Afrikaans, Bulgarian, Catalan, Czech, Danish, German, French, Galician, Hungarian, Italian, Korean, Norwegian, Dutch (Belgium), Dutch, Southern Sotho, Polish, Russian, Russian (Ukraine), Swedish, Thai, Ukrainian, Xhosa, Chinese (Hong Kong), Chinese (Taiwan), Zulu
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website