Mobile App for BP Control

Exclusion Criteria

• •1. Patients with a history of secondary hypertension or suspected secondary hypertension, including coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease.
• •2. Patients with a mean systolic BP ≥ 200 mmHg or diastolic BP ≥ 110 mmHg at the screening visit.
• •3. Patients with ≥ 20 mmHg difference between the highest and the lowest sitting systolic BP or ≥ 10 mmHg difference between highest and lowest diastolic BP, which is confirmed by triplicate measurements from the reference arm at screening.
• •4. Patients with uncontrolled diabetes (HbA1c ≥ 9.0%).
• •5. Patients who have been continuously taking other medications such as systemic steroids, thyroid hormones, oral contraceptives (except for menopausal hormone replacement therapy), psychiatric drugs, non-steroidal anti-inflammatory drugs, sympathetic drugs, and immune suppressants, which have the potential to affect BP.
• •6. Patients with symptomatic orthostatic hypotension.
• •7. Patients with a history of malignant tumors, including leukemia and lymphoma, within the past 5 years.
• •8. Patients with a history of autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus.
• •9. Patients with clinically significant kidney and liver diseases, such as those on dialysis, liver cirrhosis, biliary obstruction, and hepatic failure, or those who show the following findings during the screening visit:
• •* Alanine transaminase or aspartate transaminase level is at least 3 times higher than the normal upper limit;
• •* Total bilirubin level is more than twice the normal upper limit;
• •* Blood urea nitrogen level is more than twice the normal upper limit;
• •* Alkaline phosphatase level is more than twice the normal upper limit;
• •* Creatinine clearance level is less than 10 mL/min.
• •10. Patients with a history of the following diseases in the past 6 months, which are determined to be clinically significant by the investigator:
• •* Heart failure (NYHA class III and IV), ischemic heart diseases (coronary artery diseases, such as angina pectoris and myocardial infarction), peripheral vascular diseases, hemodynamically significant valve stenosis, and arrhythmia.
• •* Severe cerebrovascular events, including stroke, cerebral infarction, and cerebral hemorrhage.
• •11. Patients with shock.
• •12. Patients with a history of alcohol or drug abuse.
• •13. Patients with potential pregnancy or breastfeeding.
• •14. Patients who will be judged as both legally and psychologically inadequate to participate in the clinical study by the investigator.
• •15. Patients who have participated in clinical studies with other investigational drug products within 4 weeks prior to screening.