A Study on Ca Blocker Versus AII Antagonists in Hypertension With Type 2 Diabetes

July 13, 2006 updated by: Advanced-J

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical laboratory data
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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced-J

Collaborators

Japan Heart Foundation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion

September 1, 2008

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (ESTIMATE)

September 5, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2006

Last Update Submitted That Met QC Criteria

July 13, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADVANCED-J01
  • UMIN-C000000017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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