NIPH Clinical Trials Search

UMIN ID: C000000017

Registered date:29/06/2005

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

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedHypertension with type 2 diabetes mellitus
Date of first enrollment2004/11/01
Target sample size300
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Maximum dosage of Angiotensin II receptor antagonists (candesartan cilexetil, losartan potassium, telmisartan, valsartan, olmesartan medoxomil) is administered from the beginning of the study (after randomized) over 3 years. Normal dosage of AII antagonists + 5mg of Ca-channel blocker (amlodipine besilate) are administered from the beginning of the study (after randomized) over 3 years.


Primary Outcome-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 Outcome-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

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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.

Related Information


public contact
Address 1-3-25, Koishikawa, Bunkyo-ku, Tokyo, Japan 112-0002 Japan
Telephone 0120-388-512
Affiliation Secretariat for ADVANCED-J ADVANCED-J(in Mebix Inc.)
scientific contact
Name Ryuzo Kawamori, Hiroyuki Daita
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan Japan
Telephone 03-3813-3111
Affiliation Juntendo University School of Medicine Department of Endocrinology and Metabolism, Department of Cardiology