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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Advanced-J.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Japan Heart Foundation
Information provided by:
Advanced-J
ClinicalTrials.gov Identifier:
NCT00144144
First received: September 1, 2005
Last updated: July 13, 2006
Last verified: July 2006
  Purpose

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.


Condition Intervention Phase
Hypertension
Diabetes Mellitus, Type 2
Drug: Angiotensin II receptor antagonists, Calcium channel blocker
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Advanced-J:

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

Estimated Enrollment: 300
Study Start Date: September 2004
Estimated Study Completion Date: September 2008
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144144

Locations
Japan
Dept. of Clinical Immunology, Clinical Bioinformatics Research Unit, Graduate School of Medicine, the University of Tokyo
Hongo, Bunkyo-ku, Tokyo, Japan, 113-8655
Sponsors and Collaborators
Advanced-J
Japan Heart Foundation
Investigators
Principal Investigator: Ryuzo Kawamori, M.D. Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00144144     History of Changes
Other Study ID Numbers: ADVANCED-J01, UMIN-C000000017
Study First Received: September 1, 2005
Last Updated: July 13, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Advanced-J:
Hypertension
Diabetes Mellitus, Type 2
Calcium Channel Blocker
Angiotensin II type 1 Receptor Blocker

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Angiotensin II
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 23, 2014