Print

Purpose

Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1. Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation. Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD. In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent. - Diagnosed with T2DM and requiring treatment - Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease) - History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit. - At least one additional risk factor for HF: - Age ≥ 70 years - UACR > 20 mg/g - eGFR < 60 mL/min/1.73 m2 - History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease) - History of atrial fibrillation or atrial flutter - NT-proBNP > 125 ng/L

Exclusion Criteria

  • Previously confirmed diagnosis and treatment of heart failure - An eGFR < 30 mL/min/1.73 m2 at screening - Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening - Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) at screening - Serum sodium < 135 mmol/L at screening, determined as per central laboratory assessment - Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation - Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation - Percutaneous coronary intervention within 1 month prior to randomisation - Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history - Documented history of adrenal insufficiency - Any dialysis (including for acute kidney injury) within 3 months prior to screening - Any acute kidney injury within 3 months prior to screening - Prohibited concomitant medications

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Placebo controlled

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Baxdrostat/Dapagliflozin 		Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.
  • Drug: Baxdrostat and dapagliflozin
    baxdrostat tablet and dapagliflozin tablet
    Other names:
    • Baxdrostat CIN-107
Experimental
Placebo/Dapagliflozin 		Patients will receive a dose of dapagliflozin in combination with matching placebo
  • Other: Placebo and dapagliflozin
    placebo tablet and dapagliflozin tablet

Recruiting Locations

Research Site
Birmingham, Alabama 35205

Research Site
Centreville, Alabama 35042

Research Site
Fairhope, Alabama 36532

Research Site
Mobile, Alabama 36608

Research Site
Vestavia Hills, Alabama 35216

Research Site
Gilbert, Arizona 85296

Research Site
Glendale, Arizona 85308

Research Site
Tempe, Arizona 85283

Research Site
Tucson, Arizona 85712

Research Site
Huntington Beach, California 92648

Research Site
Inglewood, California 90301

Research Site
La Jolla, California 92037

Research Site
Lincoln, California 95648

Research Site
Loma Linda, California 92357

Research Site
Los Angeles, California 90035

Research Site
Sacramento, California 95841

Research Site
San Diego, California 92120

Research Site
San Dimas, California 91773

Research Site
Santa Maria, California 93454

Research Site
Thousand Oaks, California 91360

Research Site
Aurora, Colorado 80012

Research Site
Englewood, Colorado 80110

Research Site
Bridgeport, Connecticut 06606

Research Site
Stamford, Connecticut 06905

Research Site
Waterbury, Connecticut 06708

Research Site
Crystal River, Florida 34429

Research Site
Fort Lauderdale, Florida 33316

Research Site
Fort Myers, Florida 33912

Research Site
Hialeah, Florida 33012

Research Site
Jacksonville, Florida 32216

Research Site
Lakeland, Florida 33813

Research Site
Ocoee, Florida 34761

Research Site
Palmetto Bay, Florida 33157

Research Site
Saint Augustine, Florida 32086

Research Site
Albany, Georgia 31707

Research Site
Atlanta, Georgia 30303

Research Site
Canton, Georgia 30114

Research Site
Columbus, Georgia 31904

Research Site
Cordele, Georgia 31015

Research Site
Suwanee, Georgia 30024

Research Site
Woodstock, Georgia 30189

Research Site
Idaho Falls, Idaho 83404

Research Site
Champaign, Illinois 61822

Research Site
Chicago, Illinois 60616

Research Site
Chicago, Illinois 60621

Research Site
Chicago, Illinois 60631

Research Site
Gurnee, Illinois 60031

Research Site
Island Lake, Illinois 60042

Research Site
Park Ridge, Illinois 60068

Research Site
Indianapolis, Indiana 46202

Research Site
Munster, Indiana 46321

Research Site
Richmond, Indiana 47374

Research Site
South Bend, Indiana 46617

Research Site
El Dorado, Kansas 67042

Research Site
Lenexa, Kansas 66219

Research Site
Newton, Kansas 67114

Research Site
Lexington, Kentucky 40509

Research Site
Owensboro, Kentucky 42301

Research Site
Paducah, Kentucky 42001

Research Site
Alexandria, Louisiana 71303

Research Site
Baltimore, Maryland 21229

Research Site
Beltsville, Maryland 20705

Research Site
Lutherville-Timonium, Maryland 21093

Research Site
Potomac, Maryland 20854

Research Site
Boston, Massachusetts 02115

Research Site
New Bedford, Massachusetts 02740

Research Site
Roslindale, Massachusetts 02131

Research Site
Farmington Hills, Michigan 48336

Research Site
Flint, Michigan 48532

Research Site
Troy, Michigan 48098

Research Site
Mankato, Minnesota 56001

Research Site
Columbia, Missouri 65201

Research Site
Kansas City, Missouri 64111

Research Site
Kansas City, Missouri 64151

Research Site
St Louis, Missouri 63136

Research Site
Missoula, Montana 59804

Research Site
Norfolk, Nebraska 68701

Research Site
Omaha, Nebraska 68134

Research Site
Carson City, Nevada 89706

Research Site
Pennington, New Jersey 08534

Research Site
Somerset, New Jersey 08873

Research Site
Albuquerque, New Mexico 87102

Research Site
Albuquerque, New Mexico 87108

Research Site
Albany, New York 12208

Research Site
Brooklyn, New York 11201

Research Site
Brooklyn, New York 11220

Research Site
Massapequa, New York 11758

Research Site
Queens Village, New York 11428

Research Site
Charlotte, North Carolina 28287

Research Site
Durham, North Carolina 27701

Research Site
Fayetteville, North Carolina 28304

Research Site
Monroe, North Carolina 28112

Research Site
New Bern, North Carolina 28562

Research Site
Raleigh, North Carolina 27607

Research Site
Rocky Mount, North Carolina 27804

Research Site
Fargo, North Dakota 58104

Research Site
Beavercreek, Ohio 45431

Research Site
Canton, Ohio 44718

Research Site
Cincinnati, Ohio 45219

Research Site
Cincinnati, Ohio 45220

Research Site
Columbus, Ohio 43215

Research Site
Maumee, Ohio 43537

Research Site
Oklahoma City, Oklahoma 73111

Research Site
Oklahoma City, Oklahoma 73120

Research Site
Camp Hill, Pennsylvania 17011

Research Site
Horsham, Pennsylvania 19044

Research Site
Philadelphia, Pennsylvania 19114

Research Site
Scottdale, Pennsylvania 15683

Research Site
Smithfield, Pennsylvania 15478

Research Site
Fort Mill, South Carolina 29715

Research Site
Mt. Pleasant, South Carolina 29464

Research Site
North Charleston, South Carolina 29405

Research Site
Spartanburg, South Carolina 29301

Research Site
Cleveland, Tennessee 37312

Research Site
Morristown, Tennessee 37813

Research Site
Nashville, Tennessee 37203

Research Site
Austin, Texas 78704

Research Site
Beaumont, Texas 77702

Research Site
Dallas, Texas 75390-9015

Research Site
Duncanville, Texas 75137

Research Site
Houston, Texas 77084

Research Site
Houston, Texas 77089

Research Site
McAllen, Texas 78501

Research Site
McAllen, Texas 78503

Research Site
Mesquite, Texas 75149

Research Site
Paris, Texas 75462

Research Site
San Antonio, Texas 78257

Research Site
Stephenville, Texas 76401

Research Site
Sugar Land, Texas 77479

Research Site
Tomball, Texas 77375

Research Site
Weslaco, Texas 78596

Research Site
Woodway, Texas 76712

Research Site
Clearfield, Utah 84015

Research Site
Roy, Utah 84067

Research Site
Burke, Virginia 22015

Research Site
Charlottesville, Virginia 22911

Research Site
Falls Church, Virginia 22042

Research Site
Norfolk, Virginia 23502

Research Site
Redmond, Washington 98052

Research Site
Renton, Washington 98057

Research Site
Kingwood, West Virginia 26537

Research Site
Morgantown, West Virginia 26505

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.