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Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure. (DELIVER)

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ClinicalTrials.gov Identifier: NCT03619213
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.

Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction Drug: Dapagliflozin Drug: Placebo Phase 3

Detailed Description:
This is an international, multicentre, parallel-group, event-driven, randomised, double-blind study in patients with HFpEF, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death and heart failure events (hospitalisations for HF or urgent HF visits). Adult patients aged ≥40 years with HFpEF (LVEF >40% and evidence of structural heart disease) and New York Heart Association (NYHA) class II-IV who are eligible according to the inclusion/exclusion criteria will be randomised in a 1:1 ratio to receive either dapagliflozin 10 mg or placebo. Both out-patients and in-patients hospitalised for heart failure and off intravenous heart failure-therapy for 24 hours can be randomised. It is estimated that approximately 8000 patients at 400-500 sites in 20-25 countries will need to be enrolled to reach the target of approximately 4700 randomised patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: International, Double-blind, Randomised, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : June 22, 2021
Estimated Study Completion Date : June 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Dapagliflozin
Patients will be randomized 1:1 to either dapagliflozin or placebo.
Drug: Dapagliflozin
10 mg tablets given once daily, per oral use.
Other Names:
  • Forxiga TM
  • Farxiga TM

Placebo Comparator: Placebo
Placebo matching dapagliflozin.
Drug: Placebo
Placebo matching dapagliflozin 10 mg




Primary Outcome Measures :
  1. Time to the first occurrence of any of the components of this composite: 1) CV death; 2) Hospitalisation for HF; 3) Urgent HF visit (e.g., emergency department or outpatient visit) [ Time Frame: Up to approximately 33 months ]
    To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalisation for HF or urgent HF visit) in patients with HF and preserved systolic function


Secondary Outcome Measures :
  1. Total number of (first and recurrent) hospitalisations for HF and CV death [ Time Frame: up to approximately 33 months ]
    To determine whether dapagliflozin is superior to placebo in reducing the total number of recurrent HF hospitalisations and CV death

  2. Change from baseline in the total symptom score (TSS) of the KCCQ at 8 months [ Time Frame: Evaluated at 8 months after randomization ]
    To determine whether dapagliflozin is superior to placebo in improving Patient Reported Outcomes measured by KCCQ

  3. Proportion of patients with worsened NYHA class from baseline to 8 months [ Time Frame: Evaluated at 8 months after randomization ]
    To determine whether dapagliflozin is superior to placebo in reducing the proportion of patients with worsened NYHA class

  4. Time to the occurrence of death from any cause [ Time Frame: up to approximately 33 months ]
    To determine whether dapagliflozin is superior to placebo in reducing all-cause mortality


Other Outcome Measures:
  1. Serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAEs), amputations, adverse events (AEs) leading to amputation and potential risk factor AEs for amputations affecting lower limbs [ Time Frame: up to approximately 33 months ]
    Safety: To evaluate the safety and tolerability of dapagliflozin compared to placebo in patients with HFpEF



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed informed consent prior to any study specific procedures.
  2. Male or female patients age ≥40 years.
  3. Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
  4. Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
  5. Elevated NT-pro BNP levels.
  6. Both ambulatory and hospitalised patients may be enrolled and randomised. Patients currently hospitalised for HF, must be off intravenous HF medications for at least 24 before randomisation.

Further details regarding inclusion criteria 4-6 may apply.

Exclusion Criteria:

  1. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
  2. Type 1 diabetes mellitus (T1D).
  3. eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
  4. Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
  5. Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
  6. MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
  7. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
  8. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
  9. Probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism).
  10. Body mass index >50 kg/m2.

Further exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619213


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Locations
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United States, Alabama
Research Site Recruiting
Mobile, Alabama, United States, 36608
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Sheffield, Alabama, United States, 35660
United States, Arizona
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Tucson, Arizona, United States, 85724
United States, Arkansas
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Little Rock, Arkansas, United States, 72204
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Little Rock, Arkansas, United States, 72205
United States, California
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Beverly Hills, California, United States, 90211
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Loma Linda, California, United States, 92357
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Los Angeles, California, United States, 90048
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Los Angeles, California, United States, 90073
United States, Connecticut
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Stamford, Connecticut, United States, 06905
United States, Delaware
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Wilmington, Delaware, United States, 19803
United States, Florida
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Jacksonville, Florida, United States, 32216
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Miami, Florida, United States, 33155
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Naples, Florida, United States, 34102
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Ocala, Florida, United States, 34474
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Ormond Beach, Florida, United States, 32174
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Port Charlotte, Florida, United States, 33952
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Saint Augustine, Florida, United States, 32086
United States, Georgia
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Atlanta, Georgia, United States, 30303
United States, Illinois
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Chicago, Illinois, United States, 60612
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Chicago, Illinois, United States, 60637
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Gurnee, Illinois, United States, 60031
United States, Iowa
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Ames, Iowa, United States, 50010
United States, Kentucky
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Louisville, Kentucky, United States, 40202
United States, Louisiana
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Hammond, Louisiana, United States, 70403
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Morgan City, Louisiana, United States, 70380
United States, Massachusetts
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Boston, Massachusetts, United States, 02114
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Boston, Massachusetts, United States, 02115
United States, Michigan
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Ann Arbor, Michigan, United States, 48105
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Flint, Michigan, United States, 48504
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Lansing, Michigan, United States, 48910
United States, Minnesota
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Minneapolis, Minnesota, United States, 55417
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Rochester, Minnesota, United States, 55905
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Saint Paul, Minnesota, United States, 55102
United States, Mississippi
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Tupelo, Mississippi, United States, 38801
United States, Missouri
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Kansas City, Missouri, United States, 64111
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Kansas City, Missouri, United States, 64128
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Saint Louis, Missouri, United States, 63136
United States, Montana
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Great Falls, Montana, United States, 59405
United States, Nebraska
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Omaha, Nebraska, United States, 68105
United States, Nevada
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Las Vegas, Nevada, United States, 89106
United States, New Hampshire
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Lebanon, New Hampshire, United States, 03756
United States, New Jersey
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Bridgewater, New Jersey, United States, 08807
United States, New York
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Brooklyn, New York, United States, 11215
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Buffalo, New York, United States, 14215
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New York, New York, United States, 10001
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New York, New York, United States, 10021
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New York, New York, United States, 10029
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Saratoga Springs, New York, United States, 12866
United States, North Carolina
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Charlotte, North Carolina, United States, 28277
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Greensboro, North Carolina, United States, 27405
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Wilmington, North Carolina, United States, 28401
United States, Ohio
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Columbus, Ohio, United States, 43210
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Mentor, Ohio, United States, 44060
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73134
United States, Pennsylvania
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Altoona, Pennsylvania, United States, 16602
United States, Rhode Island
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Providence, Rhode Island, United States, 02908
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Warwick, Rhode Island, United States, 02886
United States, South Carolina
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Charleston, South Carolina, United States, 29425
United States, South Dakota
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Rapid City, South Dakota, United States, 57701
United States, Tennessee
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Jackson, Tennessee, United States, 38301
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Nashville, Tennessee, United States, 37212
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Nashville, Tennessee, United States, 37232
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Tullahoma, Tennessee, United States, 37388
United States, Texas
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Beaumont, Texas, United States, 77701
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Houston, Texas, United States, 77339
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San Antonio, Texas, United States, 78229
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Sherman, Texas, United States, 75092
United States, Vermont
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Burlington, Vermont, United States, 05401
United States, Virginia
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Falls Church, Virginia, United States, 22042
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Leesburg, Virginia, United States, 20176
United States, West Virginia
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Morgantown, West Virginia, United States, 26506
United States, Wisconsin
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Madison, Wisconsin, United States, 53705
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Milwaukee, Wisconsin, United States, 53295
Argentina
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Caba, Argentina, 1426
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Caba, Argentina, C1119ACN
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Caba, Argentina, C1120AAC
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Caba, Argentina, C1425AGC
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Catarmarca, Argentina
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Ciudad Autonoma de Buenos Aire, Argentina, C1440CFD
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Ciudad Autonomade Buenos Aires, Argentina, 1426
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Cordoba, Argentina, 5003
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Cordoba, Argentina, X5000AAW
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Cordoba, Argentina, X5003DCP
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Cordoba, Argentina, X5006CBI
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Corrientes, Argentina, W3400AMZ
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Córdoba, Argentina, X5004BAL
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La Plata, Argentina, 1900
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Mar del Plata, Argentina, 7600
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Ramos Mejía, Argentina, B1704ETD
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Rosario, Argentina, 2000
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San Miguel de Tucuman, Argentina, 4000
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San Nicolás, Argentina, B2900DMH
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Santa Fe, Argentina, S3000FWO
Belgium
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Bruxelles, Belgium, 1200
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Huy, Belgium, 4500
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Leuven, Belgium, 3000
Brazil
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Belo Horizonte, Brazil, 30140 062
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Belo Horizonte, Brazil, 30150-240
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Belo Horizonte, Brazil, 30190-094
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Blumenau, Brazil, 89020-430
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Campina Grande do Sul, Brazil, 83430000
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Campinas, Brazil, 13010-001
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Campinas, Brazil, 13060-080
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Porto Alegre, Brazil, 90020090
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Porto Alegre, Brazil, 90035-903
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Rio de Janeiro, Brazil, 22271-100
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Santo Andre, Brazil, 09080-110
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Sao Paulo, Brazil, 01141-020
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São Paulo, Brazil, 05403-000
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Votuporanga, Brazil, 15500-003
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Dimitrovgrad, Bulgaria, 6400
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Kozloduy, Bulgaria, 3320
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Pazardzhik, Bulgaria, 4400
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4002
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Sofia, Bulgaria, 1309
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1463
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Sofia, Bulgaria, 1606
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Sofia, Bulgaria, 1700
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Sofia, Bulgaria, 1784
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Stara Zagora, Bulgaria, 6000
Canada, Manitoba
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Cambridge, Ontario, Canada, N1R 6V6
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Oshawa, Ontario, Canada, L1J 2K1
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Peterborough, Ontario, Canada, K9J 0B2
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Port Perry, Ontario, Canada, L9L 1L1
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Scarborough, Ontario, Canada, M1B 4Z8
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Stoney Creek, Ontario, Canada, L8J 3W2
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Toronto, Ontario, Canada, M3N 1N1
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Toronto, Ontario, Canada, M5B 1W8
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Toronto, Ontario, Canada, M6G 1M2
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Toronto, Ontario, Canada, M6N 1B5
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Waterloo, Ontario, Canada, N2T 0C1
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York, Ontario, Canada, M9N 1W4
Canada, Quebec
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Laval, Quebec, Canada, H7M 3L9
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Montreal, Quebec, Canada, H1T 1C8
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Saint-Jerome, Quebec, Canada, J7Z 5T3
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Terrebonne, Quebec, Canada, J6V 2H2
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Trois-Rivieres, Quebec, Canada, G8Z 3R9
China
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Baotou, China, 014010
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Beijing, China, 100029
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Beijing, China, 100049
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Beijing, China, 100853
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Cangzhou, China, 061001
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Changchun, China, 130021
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Changchun, China, 130033
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Chengdu, China, 610041
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Chifeng, China, 024000
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Daqing, China, 163000
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Fuzhou, China, 350025
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Fuzhou, China, 350031
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Guangzhou, China, 510100
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Guangzhou, China, 510120
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Haerbin, China, 150001
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Jinan, China, 250013
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Lanzhou, China, 730030
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Nanchang, China, 330006
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Nanjing, China, 2100008
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Nanjing, China, 210009
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Nanjing, China, 210011
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Pingxiang, China, 337055
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Shanghai, China, 200025
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Shanghai, China, 200062
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Shanghai, China, 200090
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Shenyang, China, 110015
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Tianjin, China, 300000
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Tianjin, China, 300052
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Tianjin, China, 300142
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Tianjin, China, 300211
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Tianjin, China, 300457
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Wuhan, China, 430010
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Wuhan, China, 430033
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Wuhan, China, CN-430022
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Wuxi, China, 214023
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Xi'an, China, 710061
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Yinchuan, China, 750004
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Zhuhai, China, 519000
Czechia
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Benesov, Czechia, 256 01
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Brandys nad Labem, Czechia, 250 01
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Brno, Czechia, 612 00
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Brno, Czechia, 638 00
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Ceske Budejovice, Czechia, 370 06
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Dobrany, Czechia, 334 41
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Jaromer, Czechia, 551 01
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Kladno, Czechia, 272 80
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Louny, Czechia, 440 01
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Nachod, Czechia, 547 01
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Ostrava-Dubina, Czechia, 700 30
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Pardubice, Czechia, 532 03
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Pisek, Czechia, 397 01
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Plzen, Czechia, 320 00
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Prachatice, Czechia, 383 01
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Praha 2, Czechia, 12808
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Tabor, Czechia, 390 03
France
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Bayonne, France, 64100
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Corbeil-Essonnes, France, 91100
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Dijon, France, 21079
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La Tronche, France, 38700
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Le Coudray Cedex, France, 28630
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Lille, France, 59000
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Marseille Cedex 20, France, 13015
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Montpellier, France, 34295
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Paris, France, 75010
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Paris, France, 75014
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Pau Cedex, France, 64046
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Pessac, France, 33600
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Rennes Cedex 9, France, 35033
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Saint Brieuc, France, 22027
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Toulon, France, 83100
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Toulouse Cedex 9, France, 31059
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TOURCOING cedex, France, 59208
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Valenciennes, France, 59322
Hungary
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Budapest, Hungary, 1122
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Budapest, Hungary, 1139
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Budapest, Hungary, 1171
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Békéscsaba, Hungary, 5600
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Debrecen, Hungary, 4032
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Győr, Hungary, 9023
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Kecskemét, Hungary, 6000
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Miskolc, Hungary, 3529
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Nyíregyháza, Hungary, 4400
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Szekszárd, Hungary, 7100
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Szentes, Hungary, 6600
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Szolnok, Hungary, 5000
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Székesfehérvár, Hungary, 8000
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Zalaegerszeg, Hungary, 8900
Japan
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Adachi-ku, Japan, 123-0845
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Asahi-shi, Japan, 289-2511
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Azumino-shi, Japan, 399-8292
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Beppu-shi, Japan, 874-0011
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Chuo-ku, Japan, 103-0027
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Fujisawa-shi, Japan, 251-0041
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Fujisawa-shi, Japan, 251-8550
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Funabashi-shi, Japan, 274-0065
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Hachioji-shi, Japan, 192-0918
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Hamada-shi, Japan, 697-8511
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Hamamatsu-shi, Japan, 430-0929
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Higashiohmi-shi, Japan, 527-8505
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Ichinomiya-shi, Japan, 494-0001
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Iizuka-shi, Japan, 820-8505
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Iwakuni-shi, Japan, 740-8510
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Kanazawa-shi, Japan, 920-8650
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Kasugai-shi, Japan, 487-0016
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Kawasaki-shi, Japan, 210-0852
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Kishiwada-shi, Japan, 596-8522
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Kobe-shi, Japan, 654-0155
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Koga-shi, Japan, 306-0041
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Kuki-shi, Japan, 346-0021
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Kure-shi, Japan, 737-0023
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Kyoto-shi, Japan, 612-8555
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Matsumoto-shi, Japan, 390-8621
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Mito-shi, Japan, 311-4198
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Miura-gun, Japan, 240-0116
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Nakagami-gun, Japan, 901-2393
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Nishinomiya-shi, Japan, 663-8501
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Oita-shi, Japan, 870-0855
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Saga-shi, Japan, 840-8571
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Sagamihara-shi, Japan, 252-5188
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Sapporo-shi, Japan, 063-0005
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Shinagawa-ku, Japan, 140-8522
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Suita-shi, Japan, 564-8565
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Takamatsu-shi, Japan, 760-0018
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Takasago-shi, Japan, 676-0812
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Toride-shi, Japan, 302-0022
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Tsu-shi, Japan, 514-1101
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Tsuchiura-shi, Japan, 300-0028
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Ueda-shi, Japan, 386-8610
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Ureshino-shi, Japan, 843-0393
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Utsunomiya-shi, Japan, 320-8580
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Wakayama-shi, Japan, 640-8505
Mexico
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Aguascalientes, Mexico, 20230
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Culiacán, Mexico, 80200
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Guadalajara, Mexico, 44210
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Mazatlán, Mexico, 82000
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Mexico, Mexico, 06700
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Monclova, Mexico, 25750
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Monterey, Mexico, 64060
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Monterrey, Mexico, 64020
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México, Mexico, 11650
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Querétaro, Mexico, 76000
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Tijuana, Mexico, 22014
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Veracruz, Mexico, 91900
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Veracruz, Mexico, 91910
Netherlands
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Amsterdam, Netherlands, 1061 AE
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Arnhem, Netherlands, 6815 AD
Research Site Withdrawn
Den Bosch, Netherlands, 5223 GZ
Research Site Recruiting
Den Haag, Netherlands, 2545 AA
Research Site Recruiting
Dordrecht, Netherlands, 3318 AT
Research Site Recruiting
Groningen, Netherlands, 9700 RB
Research Site Recruiting
Heerlen, Netherlands, 6419 PC
Research Site Recruiting
Leiderdorp, Netherlands, 2353 GA
Research Site Recruiting
Meppel, Netherlands, 7943 KA
Research Site Recruiting
Rotterdam, Netherlands, 3083 AN
Research Site Recruiting
Uden, Netherlands, 5406 PT
Research Site Recruiting
Veldhoven, Netherlands, 5504 DB
Peru
Research Site Recruiting
Bellavista, Peru, CALLAO 2
Research Site Recruiting
Callao, Peru, CALLAO 2
Research Site Recruiting
Chancay, Peru, 15131
Research Site Recruiting
Chorrillos, Peru, Lima 9
Research Site Recruiting
Lima, Peru, 14
Research Site Recruiting
Lima, Peru, L11
Research Site Recruiting
Lima, Peru, L18
Research Site Withdrawn
Lima, Peru, LIMA 10
Research Site Recruiting
Lima, Peru, LIMA 1
Research Site Recruiting
Lima, Peru, LIMA 27
Research Site Recruiting
Lima, Peru, LIMA 31
Research Site Recruiting
Lima, Peru, LIMA 32
Research Site Recruiting
Lima, Peru, LIMA 41
Research Site Recruiting
Urb. El Chipe, Peru
Poland
Research Site Recruiting
Białystok, Poland, 15-111
Research Site Recruiting
Bochnia, Poland, 32-700
Research Site Recruiting
Chojnice, Poland, 89-600
Research Site Completed
Gdańsk, Poland, 80-286
Research Site Recruiting
Gdynia, Poland, 81-157
Research Site Recruiting
Gdynia, Poland, 81-423
Research Site Recruiting
Jasło, Poland, 38-200
Research Site Recruiting
Katowice, Poland, 40-081
Research Site Recruiting
Lublin, Poland, 20-044
Research Site Recruiting
Opole, Poland, 45-056
Research Site Recruiting
Oława, Poland, 55-200
Research Site Recruiting
Płock, Poland, 09-402
Research Site Recruiting
Rzeszów, Poland, 35-055
Research Site Recruiting
Torun, Poland, 87-100
Research Site Recruiting
Wierzchosławice, Poland, 33-122
Research Site Recruiting
Wroclaw, Poland, 50-981
Research Site Recruiting
Łódź, Poland, 92-213
Romania
Research Site Withdrawn
Brasov, Romania, 500283
Research Site Not yet recruiting
Brasov, Romania, 500365
Research Site Not yet recruiting
Craiova, Romania, 200642
Research Site Not yet recruiting
Iasi, Romania, 700304
Research Site Not yet recruiting
Iasi, Romania, 700400
Research Site Not yet recruiting
Iasi, Romania, 700515
Research Site Suspended
Sibiu, Romania, 550245
Research Site Suspended
Targu Mures, Romania, 540136
Research Site Not yet recruiting
Tg Mures, Romania, 540143
Russian Federation
Research Site Recruiting
Chelyabinsk, Russian Federation, 454091
Research Site Recruiting
Moscow, Russian Federation, 109263
Research Site Recruiting
Moscow, Russian Federation, 111539
Research Site Recruiting
Moscow, Russian Federation, 117292
Research Site Recruiting
Moscow, Russian Federation, 119991
Research Site Recruiting
Moscow, Russian Federation, 121552
Research Site Recruiting
Novosibirsk, Russian Federation, 630055
Research Site Recruiting
Perm, Russian Federation, 614056
Research Site Recruiting
Ryazan, Russian Federation, 390039
Research Site Recruiting
Saint Petersburg, Russian Federation, 198260
Research Site Recruiting
Saint-Petersburg, Russian Federation, 191015
Research Site Recruiting
Saint-Petersburg, Russian Federation, 194354
Research Site Recruiting
Saint-Petersburg, Russian Federation, 199226
Research Site Recruiting
Tver, Russian Federation, 170036
Saudi Arabia
Research Site Recruiting
Dammam, Saudi Arabia, 31463
Research Site Recruiting
Jeddah, Saudi Arabia, 21499
Research Site Recruiting
Jeddah, Saudi Arabia
Research Site Recruiting
Riyadh, Saudi Arabia, 11426
Research Site Recruiting
Riyadh, Saudi Arabia, 11462
Research Site Recruiting
Riyadh, Saudi Arabia, 11525
Spain
Research Site Recruiting
A Coruña, Spain, 15006
Research Site Recruiting
Barcelona, Spain, 08003
Research Site Recruiting
Hospitalet de Llobregat(Barcel, Spain, 08907
Research Site Recruiting
Madrid, Spain, 28040
Research Site Recruiting
Madrid, Spain, 28041
Research Site Recruiting
Sanlúcar De Barrameda (Cádiz), Spain, 11540
Research Site Recruiting
Santiago(A Coruña), Spain, 15706
Research Site Recruiting
Sevilla, Spain, 41071
Research Site Recruiting
Valencia, Spain, 46010
Research Site Recruiting
Valencia, Spain, 46026
Research Site Recruiting
Villamartín (Cádiz), Spain, 11650
Taiwan
Research Site Recruiting
Hsinchu, Taiwan, 300
Research Site Recruiting
Kaohsiung, Taiwan, 80756
Research Site Recruiting
Kaohsiung, Taiwan, 82445
Research Site Recruiting
Taichung, Taiwan, 40201
Research Site Recruiting
Taichung, Taiwan, 40705
Research Site Recruiting
Taichung, Taiwan
Research Site Recruiting
Tainan, Taiwan, 704
Research Site Recruiting
Taipei, Taiwan, 110
Research Site Recruiting
Taipei, Taiwan, 11217
Research Site Recruiting
Taipei, Taiwan, 11220
Research Site Recruiting
Taipei, Taiwan, 114
Research Site Recruiting
Taipei, Taiwan
Research Site Recruiting
Taoyuan City, Taiwan, 333
Vietnam
Research Site Recruiting
Hanoi, Vietnam, 100000
Research Site Recruiting
Hanoi, Vietnam
Research Site Recruiting
Ho Chi Minh, Vietnam, 700000
Research Site Recruiting
Ho Chi Minh, Vietnam
Sponsors and Collaborators
AstraZeneca

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03619213     History of Changes
Other Study ID Numbers: D169CC00001
2018-000802-46 ( EudraCT Number )
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs