Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure. (DELIVER)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03619213 |
|
Recruitment Status :
Recruiting
First Posted : August 7, 2018
Last Update Posted : November 18, 2019
|
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
- Study Details
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- No Results Posted
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- How to Read a Study Record
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 |
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.
| 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:
|
|
Placebo Comparator: Placebo
Placebo matching dapagliflozin.
|
Drug: Placebo
Placebo matching dapagliflozin 10 mg |
Primary Outcome Measures :
- 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 :
- 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
- 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
- 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
- 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:
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years to 130 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provision of signed informed consent prior to any study specific procedures.
- Male or female patients age ≥40 years.
- 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.
- 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.
- Elevated NT-pro BNP levels.
- 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:
- Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
- Type 1 diabetes mellitus (T1D).
- eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
- Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
- 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.
- 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.
- Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
- Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
- 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).
- 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
| Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
Hide Study Locations
Locations
| United States, Alabama | |
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| 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 | |
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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 | |
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| Wilmington, Delaware, United States, 19803 | |
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| Jacksonville, Florida, United States, 32216 | |
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| Miami, Florida, United States, 33155 | |
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| Ocala, Florida, United States, 34474 | |
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| Saint Augustine, Florida, United States, 32086 | |
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| Atlanta, Georgia, United States, 30303 | |
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| Gurnee, Illinois, United States, 60031 | |
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| Boston, Massachusetts, United States, 02114 | |
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| Lansing, Michigan, United States, 48910 | |
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| Brooklyn, New York, United States, 11215 | |
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| Jackson, Tennessee, United States, 38301 | |
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| Tullahoma, Tennessee, United States, 37388 | |
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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 | |
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| Burlington, Vermont, United States, 05401 | |
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| Falls Church, Virginia, United States, 22042 | |
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| Leesburg, Virginia, United States, 20176 | |
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| Morgantown, West Virginia, United States, 26506 | |
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| Rio de Janeiro, Brazil, 22271-100 | |
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| Santo Andre, Brazil, 09080-110 | |
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| Dimitrovgrad, Bulgaria, 6400 | |
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| Kozloduy, Bulgaria, 3320 | |
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| Stara Zagora, Bulgaria, 6000 | |
| Canada, Manitoba | |
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| Winnipeg, Manitoba, Canada, R2H 2A6 | |
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| Brampton, Ontario, Canada, L6Z 4N5 | |
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| Hamilton, Ontario, Canada, L8L 2X2 | |
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| Stoney Creek, Ontario, Canada, L8J 3W2 | |
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| Toronto, Ontario, Canada, M3N 1N1 | |
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| York, Ontario, Canada, M9N 1W4 | |
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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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| Cangzhou, China, 061001 | |
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| Xi'an, China, 710061 | |
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| Czechia | |
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| Benesov, Czechia, 256 01 | |
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| Brno, Czechia, 612 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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| 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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| 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, 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 | |
| Research Site | Recruiting |
| Miskolc, Hungary, 3529 | |
| Research Site | Recruiting |
| Nyíregyháza, Hungary, 4400 | |
| Research Site | Recruiting |
| Szekszárd, Hungary, 7100 | |
| Research Site | Recruiting |
| Szentes, Hungary, 6600 | |
| Research Site | Recruiting |
| Szolnok, Hungary, 5000 | |
| Research Site | Recruiting |
| Székesfehérvár, Hungary, 8000 | |
| Research Site | Recruiting |
| Zalaegerszeg, Hungary, 8900 | |
| Japan | |
| Research Site | Active, not recruiting |
| Adachi-ku, Japan, 123-0845 | |
| Research Site | Active, not recruiting |
| Asahi-shi, Japan, 289-2511 | |
| Research Site | Active, not recruiting |
| Azumino-shi, Japan, 399-8292 | |
| Research Site | Active, not recruiting |
| Beppu-shi, Japan, 874-0011 | |
| Research Site | Active, not recruiting |
| Chuo-ku, Japan, 103-0027 | |
| Research Site | Active, not recruiting |
| Fujisawa-shi, Japan, 251-0041 | |
| Research Site | Active, not recruiting |
| Fujisawa-shi, Japan, 251-8550 | |
| Research Site | Active, not recruiting |
| Funabashi-shi, Japan, 274-0065 | |
| Research Site | Active, not recruiting |
| Hachioji-shi, Japan, 192-0918 | |
| Research Site | Active, not recruiting |
| Hamada-shi, Japan, 697-8511 | |
| Research Site | Active, not recruiting |
| Hamamatsu-shi, Japan, 430-0929 | |
| Research Site | Active, not recruiting |
| Higashiohmi-shi, Japan, 527-8505 | |
| Research Site | Active, not recruiting |
| Ichinomiya-shi, Japan, 494-0001 | |
| Research Site | Active, not recruiting |
| Iizuka-shi, Japan, 820-8505 | |
| Research Site | Active, not recruiting |
| Iwakuni-shi, Japan, 740-8510 | |
| Research Site | Active, not recruiting |
| Kanazawa-shi, Japan, 920-8650 | |
| Research Site | Active, not recruiting |
| Kasugai-shi, Japan, 487-0016 | |
| Research Site | Active, not recruiting |
| Kawasaki-shi, Japan, 210-0852 | |
| Research Site | Active, not recruiting |
| Kishiwada-shi, Japan, 596-8522 | |
| Research Site | Active, not recruiting |
| Kobe-shi, Japan, 654-0155 | |
| Research Site | Active, not recruiting |
| Koga-shi, Japan, 306-0041 | |
| Research Site | Active, not recruiting |
| Kuki-shi, Japan, 346-0021 | |
| Research Site | Active, not recruiting |
| Kure-shi, Japan, 737-0023 | |
| Research Site | Active, not recruiting |
| Kyoto-shi, Japan, 612-8555 | |
| Research Site | Active, not recruiting |
| Matsumoto-shi, Japan, 390-8621 | |
| Research Site | Active, not recruiting |
| Mito-shi, Japan, 311-4198 | |
| Research Site | Active, not recruiting |
| Miura-gun, Japan, 240-0116 | |
| Research Site | Active, not recruiting |
| Nakagami-gun, Japan, 901-2393 | |
| Research Site | Active, not recruiting |
| Nishinomiya-shi, Japan, 663-8501 | |
| Research Site | Active, not recruiting |
| Oita-shi, Japan, 870-0855 | |
| Research Site | Active, not recruiting |
| Saga-shi, Japan, 840-8571 | |
| Research Site | Active, not recruiting |
| Sagamihara-shi, Japan, 252-5188 | |
| Research Site | Active, not recruiting |
| Sapporo-shi, Japan, 063-0005 | |
| Research Site | Active, not recruiting |
| Shinagawa-ku, Japan, 140-8522 | |
| Research Site | Active, not recruiting |
| Suita-shi, Japan, 564-8565 | |
| Research Site | Active, not recruiting |
| Takamatsu-shi, Japan, 760-0018 | |
| Research Site | Active, not recruiting |
| Takasago-shi, Japan, 676-0812 | |
| Research Site | Active, not recruiting |
| Toride-shi, Japan, 302-0022 | |
| Research Site | Active, not recruiting |
| Tsu-shi, Japan, 514-1101 | |
| Research Site | Active, not recruiting |
| Tsuchiura-shi, Japan, 300-0028 | |
| Research Site | Active, not recruiting |
| Ueda-shi, Japan, 386-8610 | |
| Research Site | Active, not recruiting |
| Ureshino-shi, Japan, 843-0393 | |
| Research Site | Active, not recruiting |
| Utsunomiya-shi, Japan, 320-8580 | |
| Research Site | Withdrawn |
| Wakayama-shi, Japan, 640-8505 | |
| Mexico | |
| Research Site | Recruiting |
| Aguascalientes, Mexico, 20230 | |
| Research Site | Recruiting |
| Culiacán, Mexico, 80200 | |
| Research Site | Recruiting |
| Guadalajara, Mexico, 44210 | |
| Research Site | Recruiting |
| Mazatlán, Mexico, 82000 | |
| Research Site | Recruiting |
| Mexico, Mexico, 06700 | |
| Research Site | Recruiting |
| Monclova, Mexico, 25750 | |
| Research Site | Recruiting |
| Monterey, Mexico, 64060 | |
| Research Site | Recruiting |
| Monterrey, Mexico, 64020 | |
| Research Site | Recruiting |
| México, Mexico, 11650 | |
| Research Site | Recruiting |
| Querétaro, Mexico, 76000 | |
| Research Site | Recruiting |
| Tijuana, Mexico, 22014 | |
| Research Site | Recruiting |
| Veracruz, Mexico, 91900 | |
| Research Site | Recruiting |
| Veracruz, Mexico, 91910 | |
| Netherlands | |
| Research Site | Recruiting |
| Amsterdam, Netherlands, 1061 AE | |
| Research Site | Recruiting |
| 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
| 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 |
| 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:
|
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 |