Clinical Trials List
2025-03-01 - 2030-06-30
Phase III
Recruiting18
ICD-10I50.20
Unspecified systolic (congestive) heart failure
ICD-10I50.21
Acute systolic (congestive) heart failure
ICD-10I50.22
Chronic systolic (congestive) heart failure
ICD-10I50.23
Acute on chronic systolic (congestive) heart failure
ICD-10I50.30
Unspecified diastolic (congestive) heart failure
ICD-10I50.31
Acute diastolic (congestive) heart failure
ICD-10I50.32
Chronic diastolic (congestive) heart failure
ICD-10I50.33
Acute on chronic diastolic (congestive) heart failure
ICD-10I50.40
Unspecified combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10I50.41
Acute combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10I50.42
Chronic combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10I50.43
Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10I50.9
Heart failure, unspecified
ICD-9428.0
Congestive heart failure
A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death
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Trial Applicant
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Sponsor
AstraZeneca Taiwan Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Cheng-Hung Li 無
- JUN-SING WANG 無
- 鄭諭聰 無
- 郭銘荏 無
- 簡育珊 無
- 王奇彥 無
- Pin-Kuei Fu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 洪元 無
- 陳彥舟 無
- 陳志維 無
- 蕭卜源 無
- Chien-Yi Hsu 無
- Yung-Ta Kao 無
- 鄭宇倫 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzung-Dau Wang 無
- 林廷澤 無
- HUNG-JU LIN 無
- 陳俊凱 無
- Chih-Fan Yeh 無
- 孟士瑋 無
- MAO-HSIN LIN 無
- Hsien Li Kao 無
- 黃慶昌 無
- CHO-KAI WU 無
- 柯宗佑 無
- 陳盈憲 無
- 鄭人方 無
- JEN-KUANG LEE 無
- 林柏志 無
- 洪啟盛 無
- 賀立婷 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wen-Chung Yu 無
- 黃偉杰 無
- Chern-En Chiang 無
- 曾致學 無
- 張俊欽 無
- 黃偉銘 無
- Kang-Ling Wang 無
- 張皓智 無
- 蔡依霖 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王宇澄 無
- 陳恬恩 無
- Shih-Sheng Chang 無
- 林晏年 無
- Lien-Cheng Hsiao 無
- 鍾偉信 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李靜娥 Division of Neurology
- Hsing-Yu Weng 無
- JOWY TANI 無
- Chih-Shan Huang 無
- 廖子崴 無
- Jia-Ying Sung Division of Neurology
- Yi-Chen Lin 無
- 陳右荏 無
- 黃仁弘 無
- 王晟安 無
- Yung-Kuo Lin 無
- 梁浩朋 無
- 陳春華 無
- 黃怡臻 無
- Ming-Hsiung Hsieh 無
- 朱克軒 無
- 林辰修 無
- 莊再庚 無
- Chin-I Chen 無
- 楊弘宇 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Dapagliflozin
Active Ingredient
Dapagliflozin
Dosage Form
116
Dosage
10 mg
Endpoints
• Hospitalization for heart failure (HF)
• Outpatient (non-hospitalized) episode of HF
• Cardiovascular (CV) death
Inclution Criteria
Participants are eligible for this study only if all of the following criteria are met:
Age
Participants of any biological sex and gender identity must be ≥ 40 years of age at the time of signing the informed consent form.
(Note: In Taiwan, the legal age of majority is ≥ 20 years.)
Participant Type and Disease Characteristics
2. Diagnosed with type 2 diabetes mellitus (T2DM) requiring treatment (see Appendix F1).
3. Established cardiovascular disease (CVD) — ischemic heart disease, cerebrovascular disease, or peripheral arterial disease (see Appendix F1).
4. History of hypertension, with systolic blood pressure (SBP) ≥ 130 mmHg at screening and ≥ 120 mmHg at randomization visit.
5. At screening, central laboratory serum potassium must meet the following criteria based on estimated glomerular filtration rate (eGFR):
For participants with eGFR ≥ 45 mL/min/1.73 m²: serum potassium between ≥ 3.0 and ≤ 4.8 mmol/L.
For participants with eGFR < 45 mL/min/1.73 m²: serum potassium between ≥ 3.0 and ≤ 4.5 mmol/L.
Presence of at least one additional risk factor for heart failure (HF):
Age ≥ 70 years
Urine albumin-to-creatinine ratio (UACR) > 20 mg/g
eGFR < 60 mL/min/1.73 m²
History of multivessel disease (at least two among ischemic heart disease, cerebrovascular disease, and peripheral arterial disease; see Appendix F1)
History of atrial fibrillation or atrial flutter
N-terminal pro–B-type natriuretic peptide (NT-proBNP) > 125 ng/L
Sexual Activity and Contraceptive/Barrier Requirements
7. Contraceptive measures must comply with local regulations governing contraception for participants in clinical trials.
Female Participants
8. Non–childbearing potential is defined as permanent sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or postmenopausal status.
A woman is considered postmenopausal if she has had no menstrual period for ≥ 12 months prior to randomization without another medical reason.
Age-specific criteria:
(a) For women < 50 years: no menses for ≥ 12 months after cessation of exogenous hormones, and FSH within postmenopausal range.
(b) For women ≥ 50 years: no menses for ≥ 12 months after cessation of all exogenous hormones.
Women of childbearing potential must use a highly effective method of contraception, defined as a method with a failure rate of <1% per year when used consistently and correctly.
These methods must be maintained throughout the study and for at least 4 weeks after the last dose of investigational product if engaging in sexual activity with a non-sterilized male partner.
(a) The following are not acceptable methods: periodic abstinence (calendar, symptothermal, or postovulatory methods), declaration of abstinence during the study period, withdrawal, spermicide-only use, lactational amenorrhea, female or male condoms alone.
(b) Highly effective methods include: complete abstinence (if consistent with participant’s lifestyle), vasectomized partner, subdermal implant (e.g., Implanon®), bilateral tubal ligation, intrauterine device (IUD) or levonorgestrel intrauterine system, injectable depot contraceptives (e.g., Depo-Provera™), ovulation-inhibiting oral contraceptives, contraceptive patches (Evra Patch™, Xulane™), or vaginal rings (NuvaRing®).
All women of childbearing potential must have a negative pregnancy test at screening and must not be breastfeeding.
Informed Consent
11. Participant must be capable of understanding and signing the informed consent form and complying with the requirements and restrictions specified therein and in the study protocol.
12. Signed and dated informed consent must be obtained prior to any study-specific procedures (informed consent collected at screening).
Exclusion Criteria
Participants are not eligible for this study if any of the following conditions apply:
Medical Conditions
Prior diagnosis or treatment of heart failure (HF).
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² at screening.
Known hyperkalemia, defined as serum potassium ≥ 5.5 mmol/L within 3 months prior to screening.
Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus at screening, defined as HbA1c > 10.5% (> 91 mmol/mol).
Serum sodium < 135 mmol/L (central lab result) at screening.
Stroke, transient ischemic attack (TIA), valve implantation or replacement, carotid surgery, carotid angioplasty, or cardiac surgery within 3 months prior to randomization.
Myocardial infarction (MI) within 3 months prior to randomization, or within 1 month prior to randomization if no further revascularization is planned.
Percutaneous coronary intervention (PCI) within 1 month prior to randomization.
Severe hepatic impairment, defined as Child-Pugh Class C cirrhosis.
Documented history of adrenal insufficiency.
Dialysis within 3 months prior to screening (including for acute kidney injury).
Acute kidney injury within 3 months prior to screening.
Known hypersensitivity or allergic reaction to the investigational product or its excipients (e.g., SGLT2 inhibitors or related active substances).
History of organ or bone marrow transplantation, or planned organ transplantation (including kidney) within 6 months after randomization.
Any clinical condition requiring systemic immunosuppressive therapy other than maintenance therapy that has been stable for at least 3 months prior to screening.
Drug or alcohol abuse deemed by the investigator to make the participant unsuitable for the study.
Prior / Concomitant Therapy
Use of any mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone, finerenone) or aldosterone synthase inhibitors within 4 weeks prior to screening and/or during the study.
Concomitant use of strong CYP3A inducers (e.g., apalutamide, avasimibe, carbamazepine, enzalutamide, lumacaftor, mitotane, phenytoin, rifampin, rifapentine, or St. John’s wort).
Use of potassium-sparing diuretics (e.g., triamterene or amiloride) or direct renin inhibitors (e.g., aliskiren) at screening.
Use of potassium-binding agents (e.g., sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening.
Other Exclusion Criteria
Any other disease or treatment judged by the investigator or sponsor to make the participant unsuitable for the study, including any active malignancy or condition with an expected life expectancy < 12 months.
Participation in another clinical trial involving an investigational product within 3 months prior to randomization.
Involvement in the planning or conduct of the study (applies to AstraZeneca employees or site personnel).
For women of childbearing potential, a positive pregnancy test at screening and/or currently breastfeeding.
The Estimated Number of Participants
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Taiwan
400 participants
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Global
11300 participants
