Patients with type 2 DM and hypertension.
Conditions
Interventions
The morning olmesartan groups of patients with type 2 DM and hypertension n=100
The pre-bedtime olmesartan groups of patients with type 2 DM and hypertension n=100
Sponsors
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age:>30 to <85 years 2)Gender: Male or female 3)Patients with type 2 DM and hypertension with outpatient blood pressure of >= 130/80 mmHg despite treatment with ARBs (candesartan, losartan, valsartan, telmisartan, irbesartan, and/or azilsartan) other than olmesartan at the usual or maximum dose for at least 12 weeks in the morning
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be included in the study: 1)Patients with secondary or malignant hypertension 2)Patients with severe heart failure (NYHA Class III or higher) 3)Patients with nephrotic syndrome (or serum creatinine [Cr] >= 3.0 mg/dL) 4)Patients with serious liver or biliary diseases 5)Patients with a history of cardiovascular (myocardial infarction) or cerebral events (cerebral infarction) 6)Patients with endocrine disease 7)Patients with any malignancy 8)Patients determined by the investigator to be not suitable for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (i) Changes in home blood pressure from before to after administration in the morning or before bedtime (early-morning, nighttime, and before bedtime blood pressure and heart rate) and the effect of the time of administration of olmesartan on Na excretion (ii) Effect of morning and pre-bedtime administration on blood-pressure variability (ME difference, mean ME, and day-by-day blood pressure variability) | — |
Secondary
| Measure | Time frame |
|---|---|
| (i) Changes in outpatient blood pressure and heart rate from before to after administration (ii) Effect on the sympathetic nervous system: Changes in cortisol levels (iii) Effect on renal function: Changes in urinary albumin and RAAS-related enzyme levels (iv) Effect on cardiac function: Changes in BNP, NT-ProBNP, and hs-cTnT levels (v) Effect on glucose metabolism: Changes in HbA1c and adiponectin levels (vi) Effect on the anti-inflammatory process: Changes in hs-CRP level (vii) Evaluation of safety such as adverse events other than the primary endpoints | — |
Countries
Japan
Contacts
Public ContactYuichiro Yano
Jichi Medical University School of Medicine Division of Cardiovascular Medicine, Department of Medicine
Outcome results
None listed