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

Primary Purpose

Hypertension, Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Angiotensin II receptor antagonists, Calcium channel blocker
Sponsored by
Advanced-J
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Diabetes Mellitus, Type 2, Calcium Channel Blocker, Angiotensin II type 1 Receptor Blocker

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept. of Clinical Immunology, Clinical Bioinformatics Research Unit, Graduate School of Medicine, the University of Tokyo

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
September 1, 2005
Last Updated
July 13, 2006
Sponsor
Advanced-J
Collaborators
Japan Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00144144
Brief Title
A Study on Ca Blocker Versus AII Antagonists in Hypertension With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Advanced-J
Collaborators
Japan Heart Foundation

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus, Type 2
Keywords
Hypertension, Diabetes Mellitus, Type 2, Calcium Channel Blocker, Angiotensin II type 1 Receptor Blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Angiotensin II receptor antagonists, Calcium channel blocker
Primary Outcome Measure Information:
Title
Changes in blood pressure level at home after getting up.
Title
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).
Title
Adverse events, adverse drug reactions
Title
Clinical laboratory data
Secondary Outcome Measure Information:
Title
Changes in blood pressure levels measured on an outpatient basis.
Title
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).
Title
Changes in blood pressure levels measured at home before going to bed· Changes in IMT of the cervical artery
Title
Changes in PWV· Changes in echocardiographic findings
Title
Changes in urinary albumin level
Title
Changes in BNP· Changes in hs-CRP· Medical cost-effectiveness

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryuzo Kawamori, M.D.
Organizational Affiliation
Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Clinical Immunology, Clinical Bioinformatics Research Unit, Graduate School of Medicine, the University of Tokyo
City
Hongo, Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan

12. IPD Sharing Statement

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

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