The antihypertensive effect of the increased dose of angiotensin II receptor blocker (AII antagonist) is compared with that of the additional combined use of amlodipine in hypertensive patients with Type 2 diabetes mellitus, who have been treated with AII antagonist, the antihypertensive effect of which has been inadequate.

Condition	Intervention	Phase
Hypertension Diabetes Mellitus, Type 2	Drug: Angiotensin II receptor antagonists, Calcium channel blocker	Phase IV

Further Study Details: 

Primary Outcomes: · Changes in blood pressure level at home after getting up.; · The rate of the blood pressure levels at home after getting up, which effected the target levels (systolic blood pressure < 125 mm Hg, diastolic blood pressure < 80 mm Hg).; · Adverse events, adverse drug reactions; · Clinical laboratory data
Secondary Outcomes: · 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 <130 mm Hg, diastolic blood pressure level < 80 mm Hg).; · 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
Expected Total Enrollment:  300

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients with type 2 diabetes mellitus.
• Patients who have been treated by the single use of AII antagonist at usual for at least 8 weeks 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.
• 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.
• Patients whose consent is obtained at age 20 years or over.
• 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:

• Patients with secondary hypertension.
• Patients who show a systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg on the measurement (in a sitting position) on an outpatient basis at the time of start of the observation period.
• Patients with severe hepatic dysfunction.
• Patients with severe renal dysfunction.
• Patients with a past history of hypersensitiveness to study drugs.
• Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant during the study period.
• Patients who have participated in the trial within 3 months before the start of the observation period or who attend the trial simultaneously with the present study.
• Other patients judged as being inappropriate for the subjects of the study by investigators.

Please refer to this study by ClinicalTrials.gov identifier  NCT00144144

Tsutomu Yamazaki, M.D.      +81-3-5800-9844    yama-tky@umin.ac.jp
Ryuzo Kawamori, M.D.      +81-3-3813-3111    kawamori@med.juntendo.ac.jp

Japan, Tokyo
      Dept. of Clinical Immunology, Clinical Bioinformatics Research Unit, Graduate School of Medicine, the University of Tokyo, Hongo, Bunkyo-ku,  Tokyo,  113-8655,  Japan; Recruiting

Study chairs or principal investigators

Ryuzo Kawamori, M.D.,  Principal Investigator,  Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism   

Study ID Numbers:  ADVANCED-J01; UMIN-C000000017
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00144144
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-06