HypertensionPhase 4NCT00144144
A Study on Ca Blocker Versus AII Antagonists in Hypertension With Type 2 Diabetes
A Phase 4 study testing Angiotensin II receptor antagonists, Calcium channel blocker in people with Hypertension and Diabetes Mellitus, Type 2, run by Advanced-J at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Type 2
- What is being tested?
- Angiotensin II receptor antagonists, Calcium channel blocker
- How many people
- 300 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2004to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Dept. of Clinical Immunology, Clinical Bioinformatics Research Unit, Graduate School of Medicine, the University of Tokyo
Hongo, Bunkyo-ku, Tokyo, 113-8655
About this study
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
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
- Being tested
- Angiotensin II receptor antagonists, Calcium channel blocker
- Keywords
- Hypertension, Diabetes Mellitus, Type 2, Calcium Channel Blocker, Angiotensin II type 1 Receptor Blocker
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin II receptor antagonists, Calcium channel blockerDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Changes in BNP· Changes in hs-CRP· Medical cost-effectiveness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startSep 2004
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Advanced-J
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Heart Foundation
- Investigators
- Ryuzo Kawamori, M.D., Principal investigator, Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144144
- Sponsor's protocol ID
- ADVANCED-J01
- Other IDs
- UMIN-C000000017
- Status last verified
- Jul 2006
- First submitted
- 1 Sep 2005
- Last updated
- 14 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00144144
- Acronym / sponsor ID
- ADVANCED-J01
- Conditions
- Hypertension, Diabetes Mellitus, Type 2
- Keywords
- Hypertension, Diabetes Mellitus, Type 2, Calcium Channel Blocker, Angiotensin II type 1 Receptor Blocker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Advanced-JUniversity, hospital or other
- Collaborators
- Japan Heart Foundation
- Study start
- Sep 2004
- Study completion
- Sep 2008
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin II receptor antagonists, Calcium channel blocker | Drug | – |
Primary outcome
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
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2006.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryuzo Kawamori, M.D. principal investigator
Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angiotensin II receptor antagonists, Calcium channel blocker in people with Hypertension and Diabetes Mellitus, Type 2, run by Advanced-J at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood pressure level at home after getting up.. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2006.