None listed
Conditions
Interventions
Drug : In this randomized study, subjects assigned to the test group will receive azilsartan medoxomil/chlorthalidone 40/12.5 mg as a fixed-dose combination administered once daily. This dose may be u
Sponsors
Celltrion Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Eligibility for study participation will be determined prior to enrollment based on the following criteria: 2. Subjects who, in the opinion of the investigator, are capable of understanding and complying with all requirements of the study protocol. 3. Subjects who voluntarily sign and date the written informed consent form prior to initiation of any study-specific procedures. 4.Subjects with a clinic seated systolic blood pressure (SBP) =160 to =190 mmHg at screening, or subjects receiving one or more antihypertensive medications at screening with a clinic seated SBP =140 to =190 mmHg. 5. Male or female subjects aged =19 years at the time of screening who voluntarily agree to participate in the study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Subjects meeting any of the following criteria will be excluded from participation in this study: 1. Subjects with secondary hypertension; severe diastolic hypertension (seated DBP >114 mmHg); paroxysmal hypertension; resistant or refractory hypertension; or any treatable cause of hypertension, including but not limited to obstructive sleep apnea or renovascular hypertension. 2. Subjects with an estimated glomerular filtration rate (eGFR) 10.0%. 4. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 × the upper limit of normal (ULN), or total bilirubin (TBIL) >1.5 × ULN at screening. 5. Subjects with a diagnosis or history of malignancy within 2 years prior to baseline. Note: Subjects with successfully treated basal cell carcinoma or =2 squamous cell skin cancers within 5 years prior to baseline may be eligible. 6. Subjects with clinically significant and uncontrolled cardiovascular disease (e.g., myocardial infarction, unstable angina, moderate to severe heart failure [NYHA Class III/IV], or stroke). Subjects with stable cardiovascular disease =3 months after acute treatment or intervention may be enrolled. Subjects with significant respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders (including depression), or clinically significant abnormal laboratory findings will also be excluded. 7. Subjects with shock (including cardiogenic shock), left ventricular outflow tract obstruction (e.g., severe aortic stenosis), refractory hyponatremia, refractory hyperkalemia, hypercalcemia, symptomatic hyperuricemia, cholestatic diseases, or primary hyperaldosteronism. 8. Night-shift workers whose work schedule may change during the study period. 9. Subjects demonstrating poor compliance with investigational product administration during the AZL-M run-in period (120%). 10. Women meeting any of the following criteria will be excluded: (1) pregnant; (2) breastfeeding; (3) positive pregnancy test at screening; (4) positive urine pregnancy test; (5) women of childbearing potential unwilling to use medically acceptable contraception during the study. Postmenopausal women with =12 months of spontaneous amenorrhea are considered non–childbearing. 11. Known or suspected infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Subjects with a positive screening test for HIV, HBsAg, or HCV, or those with such results within 1 year prior to screening, will be excluded. 12. Known hypersensitivity to ARBs, diuretics, CCBs, or any excipient contained in the investigational products. 13. History of drug or alcohol abuse within 2 years prior to enrollment. 14. Participation in another interventional clinical trial within 1 month prior to screening or within 5 half-lives of the last investigational product received (whichever is longer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the mean change from baseline (Day 1) to Week 12 in 24-hour ambulatory systolic blood pressure, as assessed by 24-hour ambulatory blood pressure monitoring (ABPM). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in clinic seated systolic blood pressure at each scheduled assessment time point.;Change from baseline in clinic seated diastolic blood pressure at each scheduled assessment time point;Proportion of responders, defined as subjects who achieve clinic systolic blood pressure <140 mmHg with a =20 mmHg reduction from baseline, or clinic diastolic blood pressure <90 mmHg with a =10 mmHg reduction from baseline, or both.;Change from baseline to Week 12 in 24-hour ABPM-measured systolic and diastolic blood pressure, including both daytime (awake) and nighttime (asleep) periods.;Change from baseline to Week 12 in sleep-time blood pressure surge parameters in subjects treated with AZL-M/CLD or TEL/AML, including: – Sleep-trough morning surge (mean early morning blood pressure minus the lowest nighttime blood pressure) – Pre-awakening surge (mean early morning blood pressure minus the pre-awakening blood pressure) | — |
Countries
Korea, Republic of
Contacts
Public ContactDong-Ju Choi
Seoul National University Bundang Hospital
Outcome results
None listed