Hypertension
Conditions
Keywords
Hypertension, Angiotensin II Receptor Blocker, Azilsartan, Valsartan
Brief summary
The purpose of this study is to compare blood pressure lowering effect of azilsartan with that of valsartan in Japanese patients with hypertension who have already taken normal-dose angiotensin II receptor blockers.
Detailed description
Hypertension plays a major role in the development of cardiovascular disease. Several guidelines require strict control of blood pressure for preventing cardiovascular events; however, the control is often poor. A new angiotensin II receptor blocker (ARB), azilsartan, is the first drug which is superior to other ARBs in blood pressure lowering in phase III clinical trials in Japan. We try to evaluate effect of azilsartan on blood pressure lowering in Japanese patients with hypertension who have already taken normal-dose ARBs, and to compare it with that of valsartan.
Interventions
DRUGAzilsartan
Azilsartan 20 mg or 40 mg (if blood pressure does not reach the target after 6 weeks) per day for 12 weeks
DRUGValsartan
Valsartan 160 mg per day
Sponsors
Nara Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Hypertensive patients treated with normal-dose angiotensin II receptor blockers (ARBs) in Japan * Normal-dose ARBs in Japan are defined as follows: losartan potassium 50 mg, candesartan cilexetil 8 mg, valsartan 80 mg, telmisartan 40 mg, olmesartan medoxomil 20 mg, or irbesartan 100mg per day.
Exclusion criteria
* Hypersensitivity for azilsartan and valsartan * Pregnant female * History of azilsartan use within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Office Blood Pressure | Baseline and every 2 weeks (up to 12 weeks) | Change in blood pressure measured at a clinic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Home Blood Pressure | Baseline and every 2 weeks (up to 12 weeks) | Change in blood pressure measured at home Blood pressure is measured twice daily in the morning fasting before taking any drugs. |
| Change in Renal Function | Baseline and 12 weeks | Changes in levels of serum creatinine and proteinuria |
| Change in Fasting Triglyceride | Baseline and 12 weeks | — |
| Change in Glycemic Control | Baseline and 12 weeks | Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed) |
| Change in Plasma Aldosterone Concentration | Baseline and 12 weeks | Only in patients with secondary hypertension |
Countries
Japan
Outcome results
None listed