UMIN-CTR Clinical Trial

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

Hypertension with type 2 diabetes mellitus

Classification by specialty

Cardiology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Central Coordinating Committee of ADVANCED-J Study Group

Institute

Department

Personal name

Organization

Japan Heart Foundation (JHF)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2005

Year

06

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2005

Year

06

Month

28

Day

Last modified on

2009

Year

06

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000031