Hypertension
Conditions
Interventions
olmesartan plus azelnidipine group
valsartan plus amlodipine group
Sponsors
Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To determine the effects of ARB (olmesartan and valsartan)-based combination therapy on the severity of cardiac failure, cardiac function disturbance, and blood surrogate markers in hypertensive subjects with cardiac function disturbance. Inclusion criteria: (1) Hypertensive (>=140/90 mmHg) subjects with untreated or treated cardiac function disturbance. In principle, subjects with hypertension who have been on antihypertensive monotherapy with the most recent casual seated SBP of >=140 mmHg or seated DBP of >=90 mmHg twice. (2) Subjects with a BNP of >=40 pg/mL. (3) Male or female subjects aged 20 years or older as of the start of observation. (4) Inpatients or outpatients. (5) Subjects allowed to switch their current antihypertensive drug to an investigational drug of the study based on the judgment of the investigator.
Exclusion criteria
Exclusion criteria: (1) Subjects with cardiogenic shock or a SBP of <80 mmHg. (2) Subjects with serious arrhythmia (such as persistent ventricular tachycardia and ventricular fibrillation), bradycardia (<50 beat/min), or second-degree or greater atrioventricular block. (3) Subjects who have developed acute cardiac infarction within 3 months prior to informed consent. (4) Subjects with unstable angina, coronary spastic angina, or angina at rest. (5) Subjects who have undergone CABG or PCI within 3 months prior to informed consent or are going to undergo CABG or PCI during the study. (6) Subjects who have developed cerebrovascular disorders (such as cerebral hemorrhage and subarachnoid hemorrhage) within 6 months prior to informed consent. (7) Subjects with bronchial asthma or other chronic respiratory disease and cor pulmonale. (8) Subjects with a history of disease with a serious prognosis such as advanced cancer within 5 years prior to informed consent. (9) Subjects with arteriosclerosis obliterans (stage II or greater in Leriche Fontaine's classification). (10) Subjects with poorly controlled diabetes mellitus (subjects with an HbAlc of >=8.0% even in antidiabetic treatment). (11) Subjects with the following serious complications: renal disorder (e.g., persistent creatinine of >=3.0 mg/dL), hepatic disorder (e.g., persistent AST or ALT of >=100 units), and anemia (e.g., persistent Hb of <=8.0 mg/dL). (12) Subjects with thyroid dysfunction difficult to control with treatment. (13) Pregnant and lactating women, women of childbearing potential, or women who want to get pregnant during the study. (14) Subjects with a history of hypersensitivity to olmesartan, valsartan, azelnidipine, and/or amlodipine. (15) Subjects for whom the administration of olmesartan, valsartan, azelnidipine, and/or amlodipine is contraindicated. (16) Subjects who are unable to give informed consent in writing. (17) Subjects judged by the investigator to be ineligible for the study due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the value of various biomarkers from baseline. BNP, hs-CRP, ADMA | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the value of various biomarkers from baseline. The proportion of patients who achieved the blood pressure goal (<130/80mmHg) after 6 months drug administration. The time course evaluation of blood pressure lowering effect. Blood tests (blood glucose, lipid, liver function, renal function). Echo-cardiography tests (EF, E/A, DT, LVDd, LVDs, LAD, LVMass). | — |
Countries
Japan
Outcome results
None listed