A Study on Ca Blocker Versus AII Antagonists in Hypertension With Type 2 Diabetes
Recruitment status was Active, not recruiting
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.
Diabetes Mellitus, Type 2
Drug: Angiotensin II receptor antagonists, Calcium channel blocker
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Controlled Study on Calcium Channel Blocker Versus Angiotensin II Antagonists in the Hypertensive Patients With Type 2 Diabetes Mellitus Under the Inadequately Controlled Blood Pressure With Angiotension II Antagonists|
- 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
- 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
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||September 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144144
|Dept. of Clinical Immunology, Clinical Bioinformatics Research Unit, Graduate School of Medicine, the University of Tokyo|
|Hongo, Bunkyo-ku, Tokyo, Japan, 113-8655|
|Principal Investigator:||Ryuzo Kawamori, M.D.||Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism|