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

NCT00144144 | Unknown Phase 4

• 2 other identifiers: ADVANCED-J01UMIN-C000000017
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Diabetes Mellitus, Type 2

Keywords

Hypertension; Diabetes Mellitus, Type 2; Calcium Channel Blocker; Angiotensin II type 1 Receptor Blocker

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

Interventions

Angiotensin II receptor antagonists, Calcium channel blocker DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced-J: lead
• Japan Heart Foundation: collaborator

Study Sites (1)

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

Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Interventions

Angiotensin Receptor Antagonists; Calcium Channel Blockers

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses

Study Officials

• Ryuzo Kawamori, M.D.

  Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: September 1, 2004
• Study Completion: September 1, 2008
• Last Updated: July 14, 2006

Record last verified: 2006-07

Locations

JP (1)