Comparison of Spironolactone and Amiloride on Home Blood Pressure in Resistant Hypertension

Korábbi kezelés

• Known cardiovascular disease (including stroke and TIA), including a history of angina, heart failure, myocardial infarction or revascularization, or cerebrovascular disease prior to 6 months
• Intolerant to test drug/drug group or its components
• Subjects who are currently participating in other clinical trials and who have taken other investigational product within the past month.
• The combination of medications known to affect blood pressure, except those permitted by the protocol.
• Other clinical conditions that, as determined by the investigator, cannot be safely completed according to the protocol or that the investigational product cannot be safely used a history of secondary hypertension that cannot be corrected

Más betegség

• White-coat uncontrolled hypertension
• Severe hypertension (WHO classification criteria grade 3 average diastolic blood pressure ≥ 110 mmHg or average systolic blood pressure ≥ 180 mmHg)
• Congestive heart failure of III-IV according to NYHA functional classification
• Clinically meaningful ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia that the investigator has deemed clinically meaningful.
• Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or stenosis on the mitral valve
• Gastrointestinal diseases that can cause potential malabsorption the gastro-intestinal tract is severely narrowed; Kock pouch (a continent pouch formed by the terminal ileum after colectomy)
• Subjects who have condition or a disease that may impede the completion of the test, according to the investigator's opinion
• History of drug or alcohol dependence within 6 months

Laborértékek

• Renal insufficiency (basal estimated glomerular filtration rate (eGFR) <50 ml / min / 1.73m2)
• liver disease or aspartate aminotransferase (AST) / alanine aminotransferase (ALT) levels > 2-fold the normal upper limit (ULN)
• Uncorrected sodium or fluid depletion

Egyéb

• Hyperkalemia (> 5.0 mmol / L, which can be reconfirmed if errors are suspected in the results)
• Bile stasis or biliary obstruction
• Pregnant or fertile women who are not contraceptive or woman who are lactating
• If assigned to treatment for this trial in the past
• Taking spironolactone or amiloride within 4 weeks from the time of screening
• If discontinued due to side effects of spironolactone or amiloride

• Age 19-75
• Patients with resistant hypertension
  • 1st screening: ven while taking three or more types of antihypertensive medications including diuretics without changing the dose for 1 month, the average office systolic blood pressure measured in three times is 130-180 mmHg and daytime systolic blood pressure is ≥130 mmHg.
  • 2nd screening: An average systolic blood pressure of home blood pressure monitoring is ≥130 mmHg during the run-in period of antihypertensive drugs including diuretics (Sevikar HCT 5/20/12.5 mg, 5/40/12.5 mg or 10/40/12.5 mg).
• Patients with resistant hypertension who have agreed to participate in the study: when they have the ability to write a written consent in accordance with the Korean Good Clinical Practice (KGCP) and local laws.
• Patients who can change the currently used antihypertensive treatment to Sevikar HCT 5/20/12.5 mg, 5/40/12.5 mg or 10/40/12.5 mg without giving unacceptable risk (investigator's judgment)