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Recruitment status No longer recruiting
Unique ID issued by UMIN C000000017
Receipt No. R000000031
Scientific 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
Date of disclosure of the study information 2005/06/29
Last modified on 2009/06/29

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Basic information
Public 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
Acronym A randomized, controlled study on Ca-channel blocker vs. AII antagonists in hypertensive patients with type 2 diabetes mellitus
Scientific 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
Scientific Title:Acronym A randomized, controlled study on Ca-channel blocker vs. AII antagonists in hypertensive patients with type 2 diabetes mellitus
Region
Japan

Condition
Condition Hypertension with type 2 diabetes mellitus
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The antihypertensive effect of the increased dose of angiotension II receptor blocker(AII antagonist)was 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.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes -Changes in blood pressure level at home after gettin up.
-The rate of the blood pressure levels at home after getting up, which effected the target levels(systolic blood pressure < 125mmHg, diastolic blood pressure < 80mmHg).
Key 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 < 130mmHg, diastolic blood pressure level < 80mmHg).
-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
-Adverse events, adverse drug reactions
-Clinical laboratory data

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Maximum dosage of Angiotensin II receptor antagonists (candesartan cilexetil, losartan potassium, telmisartan, valsartan, olmesartan medoxomil) is administered from the beginning of the study (after randomized) over 3 years.
Interventions/Control_2 Normal dosage of AII antagonists + 5mg of Ca-channel blocker (amlodipine besilate) are administered from the beginning of the study (after randomized) over 3 years.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with type 2 diabetes mellitus.
2) Patients who have been treated by the single use of AII antagonist at usual doses (Nu-lotan tablet, i.e., a losartan potassium preparation, is used in the patients who start receiving treatment from the observation period) for at least 8 weeks (including the observation period of 2 weeks or more for the present study) 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 (including the observation period of 2 weeks or more for the present study).
3) 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.
4) Patients whose consent is obtained at age 20 years or over.
5) 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 1) Patients with secondary hypertension.
2) Patients who show >180 mm Hg systolic or >110 mm Hg diastolic of the ambulatory blood pressure levels measured (in the sitting position) at the time of start of the observation period.
3) Patients with severe hepatic dysfunction.
4) Patients with severe renal dysfunction.
5) Patients with a past history of hypersensitiveness to study drugs.
6) Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant during the study period.
7) Patients who have attended the trial within 3 months before the start of the observation periond or who attend the trial simultaneously with the present study.
8) Other patients judged as being inappropriate for the subjects of the study by investigators.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuzo Kawamori, Hiroyuki Daita
Organization Juntendo University School of Medicine
Division name Department of Endocrinology and Metabolism, Department of Cardiology
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Secretariat for ADVANCED-J
Division name ADVANCED-J(in Mebix Inc.)
Zip code
Address 1-3-25, Koishikawa, Bunkyo-ku, Tokyo, Japan 112-0002
TEL 0120-388-512
Homepage URL
Email advanced-j@mebix.co.jp

Sponsor
Institute Central Coordinating Committee of ADVANCED-J Study Group
Institute
Department

Funding Source
Organization Japan Heart Foundation (JHF)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00144144
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 06 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2004 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2004 Year 11 Month 01 Day
Last follow-up date
2009 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 06 Month 28 Day
Last modified on
2009 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000031

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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