Essential hypertension
Conditions
Interventions
Nifedipine + candesartan Once daily after breakfast during 40mg administration period. Twice daily, after breakfast and before retiring, 40mg each during 80mg administration period.
Amlodipine + can
Sponsors
Kazuomi Kario
Sogo Rinsho M&
eacute
d&
fi Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with refractory hypertension who have taken 3 or more kinds of antihypertensive agents for more than a month (no matter the each dosage), or who have taken 2 agents of ARB and CCB in maximum dose of normal dose for more than a month. (2)Patients with office blood pressure (mean value of blood pressure measured twice in the same day) more than SBP 140mmHg within a month before registration, or who with home blood pressure more than SBP 140mmHg within a month before registration. (3)20 years old or older (at the time of the informed consent) male and female (4)Able to give written informed consent before participating in the research
Exclusion criteria
Exclusion criteria: (1)Secondary hypertension (2)Patients with history of myocardial infarction or cerebral stroke within 6 months (3)Patients with cardiogenic shock (4)Patients with auricular fibrillation (5)Patients with severe liver disorders or kidney disorders (6)Dialysis patients (7)Pregnant, possible to pregnancy, or lactating women (8)Patients with history of sensitivity to the ingredients (9)Any those the investigator or other researchers consider as unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour mean value of blood pressure (ABPM) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Efficacy: 1. Daytime blood pressure (ABPM) 2. Nocturnal blood pressure (ABPM) 3. Morning blood pressure (ABPM) 4. Achievement ratio to targeted value of blood pressure (set the targeted value as 24-hour mean blood pressure < 130mmHg) 5. Heart rate 6. Home blood pressure 7. Home heart rate 8. NTproBNP 9. High-sensitivity troponin T 10. Blood pressure variation index (ARV, CV, SD, Peak-Trough et al. 11. Urinary albumin excretion (adjust spot urine with creatinine) (2)Safeties: Incidence of adverse events (headache, palpitation, edema et al.) | — |
Countries
Japan
Contacts
Public ContactNobuaki Tanuma
Sogo Rinsho Medefi Co., Ltd Business Promotion Department
Outcome results
None listed