Hypertension
Conditions
Interventions
investigational material(s)
Generic name etc : Unisia Combination Tablets LD, HD (candesartan cilexetil/amlodipine)
INN of investigational material :
Therapeutic category code : 214 Antihypertensives
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: hypertensive patients
Exclusion criteria
Exclusion criteria: Patients in whom Unisia Combination Tablets are contraindicated. [Contraindications] (1) Patients with a history of hypersensitivity to the ingredients of the drug or other dihydropyridines (2) Women who are pregnant or of child-bearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events and adverse drug reactions Primary timeframe 12 months from the baseline Frequency, severity, and time to onset of adverse events and adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in blood pressure, achievement rate of the target blood pressure levels Secondary timeframe 12 months from baseline Calculation of summary statistics for actual measurement values and the change from baseline in systolic and diastolic blood pressure. | — |
Outcome results
None listed