Overview

This trial is active, not recruiting.

Conditions hypertension, diabetes mellitus, type 2
Treatment angiotensin ii receptor antagonists, calcium channel blocker
Phase phase 4
Sponsor Advanced-J
Collaborator Japan Heart Foundation
Start date September 2004
End date September 2008
Trial size 300 participants
Trial identifier NCT00144144, ADVANCED-J01, UMIN-C000000017

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Changes in blood pressure level at home after getting up.
time frame:
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).
time frame:
Adverse events, adverse drug reactions
time frame:
Clinical laboratory data
time frame:

Secondary Outcomes

Measure
Changes in blood pressure levels measured on an outpatient basis.
time frame:
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).
time frame:
Changes in blood pressure levels measured at home before going to bed· Changes in IMT of the cervical artery
time frame:
Changes in PWV· Changes in echocardiographic findings
time frame:
Changes in urinary albumin level
time frame:
Changes in BNP· Changes in hs-CRP· Medical cost-effectiveness
time frame:

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

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
Principal investigator Ryuzo Kawamori, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2006.
Information provided to ClinicalTrials.gov by Advanced-J.