Hypertension
Conditions
Interventions
investigational material(s)
Generic name etc : Blopress (candesartan cilexetil)
INN of investigational material :
Therapeutic category code : 214 Antihypertensives
Dosage and Administration for Inves
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hypertensive patients
Exclusion criteria
Exclusion criteria: (1) Inpatients (2) Patients under dialysis (planned) (3) Patients with a history of coronary artery disease/cerebrovascular disorder within 6 months (4) Patients with >= class III of the New York Heart Association (NYHA) functional classification of heart failure (5) Patients that have been prescribed with candesartan (this drug/Ecard/Unisia) in the past (6) Patients who are pregnant or may possibly become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in laboratory data such as blood pressure Primary timeframe 3 - 6 months from the baseline Tabulation of changes from the baseline in laboratory data such as blood pressure* and the amount of change. * laboratory data such as blood pressure are as follows. Blood pressure measured in the clinic (in the sitting position), blood pressure measured at home, pulse rate, glycosylated hemoglobin (HbA1c), uric acid, brain natriuretic peptide (BNP), high sensitivity C-reactive protein (hs-CRP), brachial-ankle pulse wave velocity (baPWV) (right, left), ambulatory blood pressure monitoring (ABPM) (blood pressure during sleep, blood pressure when awake, 24-hr blood pressure: mean), blood pressure measured in the clinic (in the standing position), urinary microalbumin, estimated glomerular filtration rate (eGFR), cystatin C, cognitive function (Mini-Mental State Evaluation [MMSE], Hasegawa method). | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions Secondary timeframe 3 months from the baseline Frequencyand severity of 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. | — |
Outcome results
None listed