Essential Hypertension
Conditions
Interventions
None listed
Sponsors
DAIICHI SANKYO COMPANY, LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)OLM-naive patients with essential hypertension. (2)Ambulatory outpatients who are able to visit the physician's office without any assistant or helper. (3)Patients from whom written informed consent was obtained. (4)Patients whose blood pressure levels could be measured in physician's office at least once within 28 days before starting OLM administration. (5)Patients whose early morning blood pressure levels could be measured by arm-cuff blood pressure monitor at home at least twice on different days within 28 days prior to administration of OLM.
Exclusion criteria
Exclusion criteria: (1)Patients with prior myocardial infarction, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, and stroke of unknown type (however, patients with TIA are eligible for inclusion) within the previous 6 months. (2)Patients undergoing coronary intervention surgery such as percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), and the like and those who had been hospitalized due to heart failure within the previous 6 months. (3)Patients scheduled to undergo coronary intervention surgery such as PCI, CABG, or the like when OLM is started to administer. (4)Patients with persistent or sustained atrial fibrillation. (5)Patients with history of or concurrent cardiac diseases such as congenital heart diseases, rheumatic heart disease, and moderate-to-severe valvular heart disease. (6)Patients with unstable angina pectoris or severe arrhythmia. (7)Pregnant or possibly pregnant patients. (8)Patients deemed inadequate for long-term monitoring (e.g. those under treatment for severe hepatic or renal dysfunction (patients undergoing kidney dialysis are not eligible), malignant neoplasm, and the like) as determined by physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from start of treatment to first occurrence of major cardiovascular events*. * Major cardiovascular events defined as composite of cerebral infarction, intracerebral hemorrhage, subarachnoid hemorrhage, stroke of unknown type, myocardial infarction, coronary revascularization procedures for angina pectoris, or sudden death. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Time from start of treatment to first occurrence of major events*. *Major events include major cardiovascular events, hospital admissions for angina pectoris or heart failure, aortic dissection, arteriosclerosis obliterans, end-stage renal disease, doubling of the serum creatinine concentration, and all-cause death. (2) Change in blood pressure levels. (3) Adverse events. | — |
Countries
Japan
Contacts
Public ContactShuichi Chikada
DAIICHI SANKYO COMPANY, LIMITED Medical Affairs Department
Outcome results
None listed