Hypertension
Conditions
Interventions
Olmesartan Single dose of 10 mg/day orally for 16 weeks. When necessary, olmesartan may be increased up to 40 mg/day.
Amlodipine Single dose of 2.5 mg/day orally for 16 weeks When necessary, a
Sponsors
Kagawa University, Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. eGFR is over 30 mL/min/1.73m2 when registered. 2. Written informed consent for participating in the research. Any minor under 16 years of age will need consent of a parent/legal guardian, and minors over 16 will need their own and parental/legal guardian consent. Patients who meet any of the following criteria in addition to the above will be included. 3. Untreated hypertensive patients with systolic blood pressure > 130 mmHg and < 180 mmHg and/or diastolic blood pressure > 80 mmHg and < 100 mmHg. 4. Treated hypertensive patients with systolic blood pressure > 110 mmHg and < 180 mmHg and/or diastolic blood pressure > 70 mmHg and < 100 mmHg.
Exclusion criteria
Exclusion criteria: 1. Hypertensive emergency 2. Secondary hypertension 3. Under treatment of aldosterone antagonists in the 8 weeks before registration 4. Under treatment of steroid drugs or immunosuppressive drugs, or under a 2-week (or longer) treatment of non-steroidal ant-inflammatory drugs (NSAIDs). 5. Fasting glucose > 126 mg/dl or under treatment of oral hypoglycemic drugs. 6. Severe hepatic disease (GOT >= 150 IU or GPT >= 150 IU) 7. History of cardiovascular events (myocardial infarction, etc.) in the 6 months before registration 8. History of cerebrovascular events (cerebral infarction, etc.) in the 6 months before registration. 9. Patients with malignant tumorin the 6 months before registration 10. Pregnant (possibility also), or wanting to be pregnant 11. Other inadequacies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary angiotensinogen-to-creatinine ratio (ng/mgCr) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. office blood pressure, heart rate 2. Urinary albumin-to-creatinine ratio 3. Serum creatinine or eGFR 4. Plasma angiotensinogen level 5. Plasma renin activity, plasma aldosterone 6. Cerebrovascular or cardiovasular events 7. Adverse events | — |
Countries
Japan
Contacts
Public ContactYoko Nishijima
Kagawa University, Faculty of Medicine Department of Cardiorenal and Cerebrovascular Medicine
Outcome results
None listed