Hypertension
Conditions
Interventions
investigational material(s)
Generic name etc : Zacras Combination Tablets LD & HD (azilsartan/amlodipine)
INN of investigational material :
Therapeutic category code : 214 Antihypertensives
Dosage an
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hypertensive patients
Exclusion criteria
Exclusion criteria: Hypertensive patients who meet any of the following conditions, [1] to [3], are excluded from the survey: [1] Patients with a history of hypersensitivity to any of the ingredients of Zacras Combination Tablets or other dihydropyridine drugs [2] Patients who are pregnant or having possibilities of being pregnant [3] Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events Primary timeframe: For 12 months The frequencies of all adverse events observed during the observation period will be tabulated by type, time of onset, seriousness, and causal relationship to Zacras Combination Tablets. Adverse events are defined as any unfavorable and unintended all of signs (including abnormal test values), symptoms or diseases temporally associated with administration of azilsartan/amlodipine combination tablet, whether or not it was considered related to the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Office blood pressure Secondary timeframe: From baseline to 12 months of treatment For the efficacy analysis set, the value of office blood pressure measurements, corresponding changes from baseline, and the rate of change from baseline at each assessment time point will be tabulated. | — |
Outcome results
None listed