Hypertension
Conditions
Interventions
investigational material(s)
Generic name etc : ECARD LD&HD Combination Tablets (candesartan cilexetil / hydrochlorothiazide)
INN of investigational material :
Therapeutic category code : 214 Antihype
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Post-marketing surveillance
Exclusion criteria
Exclusion criteria: (1) Patients with a history of hypersensitivity to ingredients of ECARD LD&HD combination tablets, thiazides, or their analogues (e.g. sulphonamide derivatives such as chlortalidone) (2) Patients with anuria or patients under hemodialysis (3) Patients with acute renal failure (4) Patients with noticeably decreased Na and K levels in body fluids (5) Pregnant women or women planning to become pregnant
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in blood pressure Secondary timeframe 12 months from the baseline Calculation of summary statistics for actual measured values and the change from baseline in systolic/diastolic blood pressure. Tabulation of frequency of adverse drug reactions | — |
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions Primary timeframe 12 months The frequency of adverse drug reactions by type, seriousness, time to onset. 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 the study drug are defined as adverse drug reactions. | — |
Outcome results
None listed