A Prospective, Multicentre, Randomized, Open Label, Evaluator-Blind, Phase IV Study to Evaluate the Effect on Improvement of Left Ventricular Hypertrophy by the Control of Blood Pressure in Hypertension Patients With Aortic Valve Disease

HM_AMO_401

To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and evaluate an influence of blood pressure regulation on improvement of left ventricular hypertrophy and its safety

2018-10-18

2022-07-25

2022-07-25

Completed

Early phase I

128

Inclusion Criteria: 1. Male or female aged ≥ 19 years and \< 80 years 2. Diagnosis of mild-moderate AS or mild-moderate AR 3. Applicable to 2.0\~3.9 m/s of aortic jet velocity for mild-moderate AS or to 0.2\~0.6 cm of Vena contracta for mild-moderate AR 4. Diagnosis of hypertension (SBP \> 130 mmHg if being treated or SBP \> 140 mmHg if being untreated) 5. For females of childbearing potential; negative pregnancy test results during the screening period and prior to administration of the investigational product, and agreement on use of medically allowable contraceptive measures (condom, oral contraceptive pills, injectable or implantable contraceptives, intrauterine devices, birth control patches, etc.) during the study period 6. Voluntary written consent to taking part in the clinical study and willingness to comply with requirements of the study Exclusion Criteria: 1. History of a cardiac valve replacement surgery (replacement surgery of mitral valve, aortic valve or tricuspid valve) 2. Accompanied by severe mitral regurgitation 3. Admitted to needing a surgery by the current treatment guidelines 4. Accompanied by symptoms such as angina pectoris, exertional dyspnea, syncope, etc. 5. \< 50% of left ventricular ejection fraction 6. History of hypersensitivity reaction to active ingredients of the investigational product (Amlodipine, Losartan and Chlorthalidone), dihydropyridine derivatives, thiazide drugs and other sulfonamide derivatives or their compositions 7. Pregnant or breastfeeding 8. Symptomatic orthostatic hypotension 9. Severe liver failure or renal failure (\< 30 mL/min of creatinine clearance) 10. Hereditary angioedema or history of angioedema at treatment with ACE inhibitors or angiotensin II receptor blockers 11. Primary hyperaldosteronism 12. Genetic problems such as galactose intolerance, Lapp Lapp lactase deficiency or glucose-galactose malabsorption 13. Anuria 14. Refractory hypokalemia 15. Hyponatremia or hypercalcemia 16. Symptomatic hyperuricemia (history of gout or uric acid lithiasis) 17. Untreated Addison's disease 18. Appropriately uncontrolled diabetes 19. Congenital or incurable hypertension 20. Diagnosis of severe cerebrovascular disorders (stroke, cerebral infarction, cerebral hemorrhage, etc.) within six months prior to the date of ICF obtainment 21. Wasting disease, autoimmune disease or connective tissue disease 22. Diagnosis of malignant tumor within five years prior to the date of ICF obtainment 23. Administration of another investigational product within four weeks prior to the date of ICF obtainment 24. For a patient who is taking anticoagulants and thrombolytic agents; considered difficult to keep a stable dosage/regimen by the investigator. 25. Considered unsuitable to be a subject by the investigator

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2022-09-15