Hypertension with type 2 diabetes mellitus
Conditions
Interventions
Maximum dosage of Angiotensin II receptor antagonists (candesartan cilexetil, losartan potassium, telmisartan, valsartan, olmesartan medoxomil) is administered from the beginning of the study (after r
Sponsors
Central Coordinating Committee of ADVANCED-J Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with type 2 diabetes mellitus. 2) Patients who have been treated by the single use of AII antagonist at usual doses (Nu-lotan tablet, i.e., a losartan potassium preparation, is used in the patients who start receiving treatment from the observation period) for at least 8 weeks (including the observation period of 2 weeks or more for the present study) or patients who have been treated by the combined use of AII antagonist at usual doses and calcium channel blocker or a antihypertensive drug other than ACE inhibitors for at least 8 weeks (including the observation period of 2 weeks or more for the present study). 3) Patients who show a systolic blood pressure (blood pressure) > 135 mm Hg or a diastolic blood pressure > 85 mm Hg, which is measured (in a sitting position) on an outpatient basis at the time of start of the observation period, and show the mean (blood pressure level measured at home after getting up before the start of study) of systolic blood pressure > 130 mm Hg or diastolic blood pressure > 80 mm Hg measured at home after getting up for last 5 days during the last 2-week observation period. 4) Patients whose consent is obtained at age 20 years or over. 5) Patients whose consent is obtained from themselves in written form. With regard to 2) and 3), however, the case, in which the mean of the systolic blood pressure levels measured at home after getting up for last 5 days during the first 1-week observation period is > 180 mm Hg or the mean diastolic blood pressure level is > 110 mm Hg, is included in the present study.
Exclusion criteria
Exclusion criteria: 1) Patients with secondary hypertension. 2) Patients who show >180 mm Hg systolic or >110 mm Hg diastolic of the ambulatory blood pressure levels measured (in the sitting position) at the time of start of the observation period. 3) Patients with severe hepatic dysfunction. 4) Patients with severe renal dysfunction. 5) Patients with a past history of hypersensitiveness to study drugs. 6) Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant during the study period. 7) Patients who have attended the trial within 3 months before the start of the observation periond or who attend the trial simultaneously with the present study. 8) Other patients judged as being inappropriate for the subjects of the study by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Changes in blood pressure level at home after gettin up. -The rate of the blood pressure levels at home after getting up, which effected the target levels(systolic blood pressure < 125mmHg, diastolic blood pressure < 80mmHg). | — |
Secondary
| Measure | Time frame |
|---|---|
| -Changes in blood pressure levels measured on an outpatient basis. -The rate of the blood pressure levels measured on an outpatient basis, which effected the standard levels(systolic blood pressure level < 130mmHg, diastolic blood pressure level < 80mmHg). -Changes in blood pressure levels measured at home before going to bed -Changes in IMT of the cervical artery -Changes in PWV -Changes in echocardiographic findings -Changes in urinary albumin level -Changes in BNP -Changes in hs-CRP -Medical cost-effectiveness -Adverse events, adverse drug reactions -Clinical laboratory data | — |
Countries
Japan
Outcome results
None listed