Hypertension
Conditions
Interventions
investigational material(s)
Generic name etc : Blopress Tablets (candesartan cilexetil)
INN of investigational material :
Therapeutic category code : 214 Antihypertensives
Dosage and Administration f
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hypertensive patients with at least one of the following risk factors: - Waist circumference >= 85 cm for male and >= 90 cm for female - Fasting triglyceride level >= 150 mg/dL - High-density lipoprotein (HDL) cholesterol level = 110 mg/dL - Body-mass index (BMI) >= 25.0 *Patients currently taking medications for hypertriglyceridemia, hypo-HDL-cholesterolemia, or diabetes mellitus are also regarded as meeting the criteria for inclusion in the surveillance
Exclusion criteria
Exclusion criteria: Hypertensive patients who meet all of the following conditions ([1] to [3]): [1] Patients receiving continuous therapy with Blopress Tablets [2] Patients aged = 75 years [3] Patients with a history of cerebrovascular or coronary artery disease within 6 months before the start of the surveillance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of cerebrovascular/cardiovascular events Primary timeframe: 3 years from baseline If a cerebrovascular/cardiovascular event occurs, the physicians in charge of the surveillance should enter the following information in the "cerebrovascular/cardiovascular events survey form:" (i) rationale for diagnosing, (ii) onset date, (iii) seriousness and the rationale for the assessment of seriousness, (iv) causality between the event and Blopress Tablets, (v) treatment of the event, (vi) assessment date of outcome, and (vii) outcome, when completing the survey form. - Sudden death - Cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage - Acute myocardial infarction, hospitalization due to heart failure, intervention for angina pectoris or hospitalization due to angina pectoris, or atrial fibrillation - Transition to dialysis, or renal transplantation - Dissecting aortic aneurysm - Diabetic retinopathy - New onset of diabetes mellitus | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions Secondary timeframe: Up to 3 years The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of candesartan cilexetil whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with candesartan cilexetil are defined as adverse drug reactions. | — |
Outcome results
None listed