Last updated: 07/17/2024 17:02:46
Anemia Studies in Chronic Kidney Disease: Erythropoiesis via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A phase 3 randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa
Trial description: The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Time to the first occurrence of adjudicated major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal myocardial infarction (MI) and non-fatal stroke)
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Mean change in hemoglobin (Hgb) between baseline and efficacy period (EP) (mean over Weeks 28-52)
Timeframe: Baseline, up to and including Week 52
Secondary outcomes:
Time to first occurrence of adjudicated MACE
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Time to first occurrence of adjudicated MACE or a thromboembolic event (vascular access thrombosis, symptomatic deep vein thrombosis or symptomatic pulmonary embolism)
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Time to first occurrence of adjudicated MACE or a hospitalization for heart failure (HF)
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Time to progression of CKD
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Time to first occurrence of all-cause mortality, cardiovascular (CV) mortality, fatal or non-fatal MI, fatal or non-fatal stroke
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Time to first occurrence of MACE or hospitalization for HF (recurrent events analysis)
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Time to first occurrence of all-cause hospitalization
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Time to first occurrence of all cause hospital re-admission within 30 days
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Time to first occurrence of MACE or hospitalization for HF or thromboembolic events
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Time to first occurrence of hospitalization for HF
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Time to first occurrence of thromboembolic events
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Time to first occurrence of individual components of CKD progression
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Percentage of responders, defined as mean Hgb within the Hgb analysis range
Timeframe: Up to and including Week 52
Number of blood pressure (BP) exacerbation events per 100 patient years
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Percentage of participants with least one BP exacerbation event during study
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Number of participants with least one BP exacerbation event during study
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Time to stopping randomized treatment due to meeting rescue criteria
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score at Week 52
Timeframe: Baseline, up to and including Week 52
Change from Baseline in EQ-5D-5L visual analog scale (VAS) at Week 52
Timeframe: Baseline, up to and including Week 52
Time to first occurrence of CV death or non fatal MI
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Hgb change from baseline to Week 52
Timeframe: Baseline, up to and including Week 52
Number of responders, defined as mean Hgb within the Hgb analysis range
Timeframe: Up to and including Week 52
Percentage time for which Hgb is in analysis range during the EP (Week 28 to 52) and during the maintenance period (MP; Week 28 to end of trial)
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 4.1 years)
Change from baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52 and at end of treatment
Timeframe: Baseline and up to 4.1 years)
Mean change in SF-36 Health Related Quality of Life (HRQOL) scores between Baseline and Weeks 8, 12, 28, 52, of particular interest are the changes from baseline in the vitality and physical functioning domains at Weeks 28 and 52
Timeframe: Baseline, up to and including Week 52
Change from Baseline by domain and overall symptom score on the CKD-Anemia Questionnaire (AQ) at Weeks 8, 12, 28, 52
Timeframe: Baseline, up to and including Week 52
Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) at Week 8, 12, 28 and 52
Timeframe: Baseline, up to and including Week 52
Change from Baseline in estimated glomerular filtration rate (eGFR) at Week 52
Timeframe: Baseline and at Week 52
Interventions:
Enrollment:
3872
Primary completion date:
2021-19-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Ajay K. Singh, Kevin Carroll, John J. V. McMurray, Scott Solomon, Vivekanand Jha, Kirsten L. Johansen, Renato D. Lopes, Iain C. Macdougall, Gregorio T. Obrador, Sushrut S. Waikar, Christoph Wanner, David C. Wheeler, Andrzej Wiecek, Allison Blackorby, Borut Cizman, Alexander R. Cobitz, Rich Davies, Tara L. DiMino, Lata Kler, Amy M. Meadowcroft, Lin Taft, Vlado Perkovic for the ASCEND-ND Study Group. DAPRODUSTAT FOR THE TREATMENT OF ANEMIA IN PATIENTS NOT UNDERGOING DIALYSIS. N Engl J Med. 2021;
DOI: 10.1056/NEJMoa2113380
PMID: 34739196
Vlado Perkovic, Allison Blackorby, Borut Cizman, Kevin Carroll, Alexander R. Cobitz, Rich Davies, Tara L. DiMino, Vivekanand Jha, Kirsten L. Johansen, Renato D. Lopes, Lata Kler, Iain C. Macdougall, John McMurray, Amy M. Meadowcroft, Gregorio T. Obrador, Scott Solomon, Lin Taft, Christoph Wanner, Sushrut S. Waikar, David C. Wheeler, Andrzej Wiecek, Ajay Singh.The ASCEND-ND trial: Study design and participant characteristics.Nephrol Dial Transplant.2021; DOI: 10.1093/ndt/gfab318 PMID: 34865143
Medical condition
Anaemia
Product
daprodustat, darbepoetin alfa
Collaborators
Not applicable
Study date(s)
September 2016 to April 2021
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 99 Years
Accepts healthy volunteers
No
- Age: 18 to 99 years of age (inclusive)
- CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by electronic eGFR using the CKD Epidemiology Collaboration (CKD-EPI) formula.
- Dialysis: On dialysis or clinical evidence of impending need to initiate dialysis within 90 days after study start (Day 1).
- Kidney transplant: Planned living-related or living-unrelated kidney transplant within 52 weeks after study start (Day 1).
Inclusion and exclusion criteria
Inclusion criteria:
- Age: 18 to 99 years of age (inclusive)
- CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by electronic eGFR using the CKD Epidemiology Collaboration (CKD-EPI) formula.
- Erythropoietin-stimulating agents (ESAs)/Hgb: Group 1 (not using ESAs): No ESA use within the 6 weeks prior to screening and no ESA use between screening and randomization (Day 1). Group 2 (ESA users): Use of any approved ESA for the 6 weeks prior to screening and continuing between screening and randomization.
- For Group 1 (not using ESAs), Hgb concentration at Week -8 and Week 1 should be 8 to 10 gram per deciliter (g/dL). For Group 2 (ESA users), Hgb concentration at Week -8 should be 8 to 12 g/dL and at Week 1 should be 8 to 11 g/dL.
- >=80% and <=120% compliance with placebo during run-in period.
- Informed consent (screening only): capable of giving signed informed consent which includes compliance with the requirements and restrictions.
Exclusion criteria:
- Dialysis: On dialysis or clinical evidence of impending need to initiate dialysis within 90 days after study start (Day 1).
- Kidney transplant: Planned living-related or living-unrelated kidney transplant within 52 weeks after study start (Day 1).
- Ferritin: <=100 nanograms (ng)/milliliter (mL) (<=100 micrograms/liter [L]) at screening.
- Transferrin saturation (TSAT) (screening only): <=20%.
- Aplasias: History of bone marrow aplasia or pure red cell aplasia.
- Other causes of anemia: untreated pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome.
- Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant GI bleeding <=4 weeks prior to screening through to randomization (Day 1).
- MI or acute coronary syndrome: <=4 weeks prior to screening through to randomization (Day 1).
- Stroke or transient ischemic attack: <=4 weeks prior to screening through to randomization (Day 1).
- Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.
- Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the investigator.
- Bazett’s corrected QT interval (QTcB) (Day 1): QTcB >500 millisecond (msec), or QTcB >530 msec in subjects with bundle branch block. There is no Q-T Interval Corrected for Heart Rate (QTc) exclusion for subjects with a predominantly ventricular paced rhythm.
- Alanine transaminase (ALT): >2x upper limit of normal (ULN) at screening.
- Bilirubin: >1.5xULN at screening.
- Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
- Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1) or currently receiving treatment for cancer, or complex kidney cyst (example [e.g.] Bosniak Category II F, III or IV) > 3 centimeter (cm); with the exception of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated >=4 weeks prior to screening.
- Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product, or darbepoetin alfa.
- Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin).
- Other study participation: Use of other investigational agent or device prior to screening through to randomization (Day 1). At screening, this exclusion applies to use of the investigational agent within 30 days or within five half lives (whichever is longer).
- Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of >30 days.
- Females only: Subject is pregnant [as confirmed by a positive urine human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options.
- Other Conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g., intolerance to darbepoetin alfa) or prevent understanding of the aims or investigational procedures or possible consequences of the study.
Trial location(s)
Location
GSK Investigational Site
Aguascalientes, Aguascalientes, Mexico, 20230
Status
Study Complete
Location
GSK Investigational Site
Alexandria, Virginia, United States, 22304
Status
Study Complete
Location
GSK Investigational Site
Andalusia, Alabama, United States, 36420
Status
Study Complete
Location
GSK Investigational Site
Anderson, South Carolina, United States, 29621
Status
Study Complete
Location
GSK Investigational Site
Anyang-Si, Gyeonggi-do, South Korea, 14068
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30904
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30909
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30912
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85305
Status
Study Complete
Location
GSK Investigational Site
Baguio City, Benguet, Philippines, 2600
Status
Study Complete
Location
GSK Investigational Site
Bakersfield, California, United States, 93308
Status
Study Complete
Location
GSK Investigational Site
Bakersfield, California, United States, 93309
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70836
Status
Study Complete
Location
GSK Investigational Site
Bethlehem, Pennsylvania, United States, 18017
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35249
Status
Study Complete
Location
GSK Investigational Site
Bluefield, West Virginia, United States, 24701
Status
Study Complete
Location
GSK Investigational Site
Boca Raton, Florida, United States, 33431
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11203
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1181ACH
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14215
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29425
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60611
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60643
Status
Study Complete
Location
GSK Investigational Site
Chula Vista, California, United States, 91910
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45206
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45220
Status
Study Complete
Location
GSK Investigational Site
Ciudad De Mexico, Estado de México, Mexico, 14080
Status
Study Complete
Location
GSK Investigational Site
Ciudad Evita, Buenos Aires, Argentina, B1778IFA
Status
Study Complete
Location
GSK Investigational Site
Cloppenburg, Niedersachsen, Germany, 49661
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29209
Status
Study Complete
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Study Complete
Location
GSK Investigational Site
Concord, New South Wales, Australia, 2139
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Cordova, Tennessee, United States, 38018
Status
Study Complete
Location
GSK Investigational Site
Coronel Suarez, Buenos Aires, Argentina, 7540
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78404
Status
Study Complete
Location
GSK Investigational Site
Corrientes, Corrientes, Argentina, W3400AMZ
Status
Study Complete
Location
GSK Investigational Site
Corsicana, Texas, United States, 75110
Status
Study Complete
Location
GSK Investigational Site
Crystal Lake, Illinois, United States, 60014
Status
Study Complete
Location
GSK Investigational Site
Cudahy, California, United States, 90201
Status
Study Complete
Location
GSK Investigational Site
Curitiba, Paraná, Brazil, CEP 80230-130
Status
Study Complete
Location
GSK Investigational Site
Cutler Bay, Florida, United States, 33189
Status
Study Complete
Location
GSK Investigational Site
Des Moines, Iowa, United States, 50309
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48202
Status
Study Complete
Location
GSK Investigational Site
Doylestown, Pennsylvania, United States, 18901
Status
Study Complete
Location
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40210
Status
Study Complete
Location
GSK Investigational Site
El Centro, California, United States, 92243
Status
Study Complete
Location
GSK Investigational Site
Escondido, California, United States, 92025
Status
Study Complete
Location
GSK Investigational Site
Fairfax, Virginia, United States, 22033
Status
Study Complete
Location
GSK Investigational Site
Flushing, New York, United States, 11355
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
Status
Study Complete
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46845
Status
Study Complete
Location
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Status
Study Complete
Location
GSK Investigational Site
Glendale, California, United States, 91204
Status
Study Complete
Location
GSK Investigational Site
Gosford, New South Wales, Australia, 2250
Status
Study Complete
Location
GSK Investigational Site
Ilsanseo-gu, Goyang-si,, South Korea, 10380
Status
Study Complete
Location
GSK Investigational Site
Granada Hills, California, United States, 91344
Status
Study Complete
Location
GSK Investigational Site
Grand Forks, North Dakota, United States, 58201
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H1
Status
Study Complete
Location
GSK Investigational Site
Hampstead, London, United Kingdom, NW3 2QG
Status
Study Complete
Location
GSK Investigational Site
Hampton, Virginia, United States, 23666
Status
Study Complete
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35805
Status
Study Complete
Location
GSK Investigational Site
Hutchinson, Kansas, United States, 67502
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39216
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32224
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32256
Status
Study Complete
Location
GSK Investigational Site
Jeffersonville, Indiana, United States, 47130
Status
Study Complete
Location
GSK Investigational Site
JunÃn, Buenos Aires, Argentina, B6000GMA
Status
Study Complete
Location
GSK Investigational Site
Kaiserslautern, Rheinland-Pfalz, Germany, 67655
Status
Study Complete
Location
GSK Investigational Site
Kalmazoo, Michigan, United States, 49007
Status
Study Complete
Location
GSK Investigational Site
Kingswood, New South Wales, Australia, 2747
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37923
Status
Study Complete
Location
GSK Investigational Site
Kogarah, New South Wales, Australia, 2217
Status
Study Complete
Location
GSK Investigational Site
L'Hospitalet de Llobregat, Spain, 08907
Status
Study Complete
Location
GSK Investigational Site
La Mesa, California, United States, 91942
Status
Study Complete
Location
GSK Investigational Site
La Palma, California, United States, 90623
Status
Study Complete
Location
GSK Investigational Site
Lancaster, Pennsylvania, United States, 17601
Status
Study Complete
Location
GSK Investigational Site
Las vegas, Nevada, United States, 89106
Status
Study Complete
Location
GSK Investigational Site
Lauderdale Lakes, Florida, United States, 33313
Status
Study Complete
Location
GSK Investigational Site
Laurelton, New York, United States, 11413
Status
Study Complete
Location
GSK Investigational Site
Liverpool, Merseyside, United Kingdom, L7 8XP
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90022
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Study Complete
Location
GSK Investigational Site
Azusa, California, United States, 91702
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, 7600
Status
Study Complete
Location
GSK Investigational Site
Marianske Lazne, Czech Republic, 353 01
Status
Study Complete
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Homestead, Florida, United States, 33033
Status
Study Complete
Location
GSK Investigational Site
Miami Gardens, Florida, United States, 33169
Status
Study Complete
Location
GSK Investigational Site
Miami Lakes, Florida, United States, 33014
Status
Study Complete
Location
GSK Investigational Site
Michigan City, Indiana, United States, 46360
Status
Study Complete
Location
GSK Investigational Site
Middlebury, Connecticut, United States, 06762
Status
Study Complete
Location
GSK Investigational Site
Middlesbrough, United Kingdom, TS4 3BW
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55414
Status
Study Complete
Location
GSK Investigational Site
Montebello, California, United States, 90640
Status
Study Complete
Location
GSK Investigational Site
Mount Prospect, Illinois, United States, 60056
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37205
Status
Study Complete
Location
GSK Investigational Site
National City, California, United States, 91950
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10029
Status
Study Complete
Location
GSK Investigational Site
North Platte, Nebraska, United States, 69101
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32810
Status
Study Complete
Location
GSK Investigational Site
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33028
Status
Study Complete
Location
GSK Investigational Site
Pergamino, Buenos Aires, Argentina, B2700CPM
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85016
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85027
Status
Study Complete
Location
GSK Investigational Site
Piacenza, Emilia-Romagna, Italy, 29100
Status
Study Complete
Location
GSK Investigational Site
Pontiac, Michigan, United States, 48341
Status
Study Complete
Location
GSK Investigational Site
Port Charlotte, Florida, United States, 33952
Status
Study Complete
Location
GSK Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6001
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 48201
Status
Study Complete
Location
GSK Investigational Site
Preston, Lancashire, United Kingdom, PR2 9HT
Status
Study Complete
Location
GSK Investigational Site
Quincy, Illinois, United States, 62301
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Status
Study Complete
Location
GSK Investigational Site
Reggio Emilia, Emilia-Romagna, Italy, 42123
Status
Study Complete
Location
GSK Investigational Site
Ridgewood, New York, United States, 11385
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92505
Status
Study Complete
Location
GSK Investigational Site
Potomac, Maryland, United States, 20854
Status
Study Complete
Location
GSK Investigational Site
Roseburg, Oregon, United States, 97471
Status
Study Complete
Location
GSK Investigational Site
Saint Louis, Missouri, United States, 63106
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78202
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, 92111
Status
Study Complete
Location
GSK Investigational Site
San Luis Obispo, California, United States, 93405
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucumán, Argentina, T4000AHL
Status
Study Complete
Location
GSK Investigational Site
Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
Status
Study Complete
Location
GSK Investigational Site
Simi Valley, California, United States, 93065
Status
Study Complete
Location
GSK Investigational Site
South Miami, Florida, United States, 33143
Status
Study Complete
Location
GSK Investigational Site
Springfield, Illinois, United States, 62702
Status
Study Complete
Location
GSK Investigational Site
St Leonards, New South Wales, Australia, 2065
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Status
Study Complete
Location
GSK Investigational Site
Sumter, South Carolina, United States, 29150
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 01323903
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04039-000
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, ?04005-000
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, ?08270-070
Status
Study Complete
Location
GSK Investigational Site
Takapuna, Auckland, New Zealand, ?0740
Status
Study Complete
Location
GSK Investigational Site
Takoma Park, Maryland, United States, 20912-6385
Status
Study Complete
Location
GSK Investigational Site
Tarzana, California, United States, 91356
Status
Study Complete
Location
GSK Investigational Site
Tupelo, Mississippi, United States, 38801
Status
Study Complete
Location
GSK Investigational Site
Votuporanga, São Paulo, Brazil, 15500-003
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20037
Status
Study Complete
Location
GSK Investigational Site
Whittier, California, United States, 90602
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, 27103
Status
Study Complete
Location
GSK Investigational Site
Wollongong, New South Wales, Australia, 2500
Status
Study Complete
Location
GSK Investigational Site
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Status
Study Complete
Location
GSK Investigational Site
Wyomissing, Pennsylvania, United States, 19610
Status
Study Complete
Location
GSK Investigational Site
Yonkers, New York, United States, 10704
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21287
Status
Study Complete
Location
GSK Investigational Site
Temple Terrace, Florida, United States, 33637
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Rocky Mount, North Carolina, United States, 27804
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38163
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78212
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76002
Status
Study Complete
Location
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
Status
Study Complete
Location
GSK Investigational Site
Waxahachie, Texas, United States, 75165
Status
Study Complete
Location
GSK Investigational Site
Lawton, Oklahoma, United States, 73505
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
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
2021-19-04
Actual study completion date
2021-19-04
Plain language summaries
Summary of results in plain language
Available language(s): English, Spanish (Argentina), Dutch (Belgium), Portuguese (Brazil), Bulgarian, French (Canadian), Spanish (Columbia), Czech, Danish, Estonian, French, German, Greek, Chinese (Hong Kong), Hungarian, Hindi, Kannada, Marathi, Malayalam, Tamil (India), Telugu, Gujarati, Urdu, Hebrew, Russian (Israel), Arabic (Israel), Italian, Korean, Malay (Malaysia), Chinese (Malaysia), Spanish (Mexico), Dutch, Samoan, Tongan (New Zealand), Tagalog, Cebuano, Hiligaynon, Ilocano (Philippines), Polish, Portuguese (Native), Romanian, Russian, Afrikaans, Spanish, Catalan, Swedish, Chinese (Taiwan), Turkish, Thai, Russian (Ukraine), Ukrainian, Vietnamese, Spanish (United States), Malay (Singapore), Tamil (Singapore), Tamil (Malaysia)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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