UMIN-CTR Clinical Trial

Public title

Angiotensin receptor blocker/Calcium antagonist combination therapy on diurnal blood pressure variation

Acronym

Angiotensin receptor blocker/Calcium antagonist combination therapy on diurnal blood pressure variation

Scientific Title

Angiotensin receptor blocker/Calcium antagonist combination therapy on diurnal blood pressure variation

Scientific Title:Acronym

Angiotensin receptor blocker/Calcium antagonist combination therapy on diurnal blood pressure variation

Region

Japan

Condition

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

1) To examine the effects of AIMIX(R) combination tablet (Amlodipine 10mg/Irbesartan 100mg) therapy on blood pressure reduction and organ damage protection and to document side effects.

2) To document the proportion of extreme-dipper, dipper, non-dipper and riser in the patients who are poorly controlled hypertension (clinic systolic BP more than or equal to 140/90 mm Hg despite the combination therapy with Calcium antagonist [Amlodipine 5mg] and angiotensin II receptor antagonist [any one of the following drugs: losartan 50mg, valsartan 80mg, candesartan 8mg, telmisartan 40mg, olmesartan 20mg, azilsartan 20mg]).

3) To document the proportion of extreme-dipper, dipper, non-dipper and riser in patients treated with AIMIX(R) combination tablet.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

- Target blood pressure reduction rate (clinic blood pressure less than 140/90 mm Hg ).
- To document the proportion of extreme-dipper, dipper, non-dipper and riser (diurnal blood pressure variation).

Key secondary outcomes

- Target blood pressure achievement rate and blood pressure lowering level at the final assessment.
- Change in serum creatinine level (e-GFR) and microalbumin level.
*eGFR(mL/min/1.73m2) = 194 X Cr -1.094 X age -0.287 X Cr -1.154 (X 0.739 for women)
- Change in highly sensitive cardiac troponin T (hs-cTnT), NT-proBNP.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

AIMIX(R) combination tablet

Interventions/Control_2

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

Patients who meet all of the following criteria:
Patients aged 20 years old and over.
Patients who have clinic systolic BP more than or equal to 140/90 mm Hg despite the combination therapy with Calcium antagonist (Amlodipine 5mg) and angiotensin II receptor antagonist (any one of the following drugs: losartan 50mg, valsartan 80mg, candesartan 8mg, telmisartan 40mg, olmesartan 20mg, azilsartan 20mg).

Key exclusion criteria

Patients who meet one of the following criteria are excluded:
1) Secondary hypertension
2) Congestive heart failure; onset of acute myocardial infarction in the past 6 month; onset of cerebrovascular disturbance in the past 6 month; current atrial fibrillation or atrioventricular block or severe arrhythmia.
3) hepatic insufficiency (AST or ALT >X2 the upper limit of the normal range) , renal insufficiency (serum Crl.>1.5mg/dL)
4) Diabetic patients being treated with aliskiren.
5) Allergy or drug hypersensitivity.
6) Lack of the informed consent for any reason (e.g. dementia).
7) Women suspected of being pregnant.
8) Patients being ineligible by the attending physicians.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Kazuomi Kario

Organization

Jichi Medical University School of Medicine

Division name

Division of Cardiovascular Medicine,

Zip code

Address

3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN

TEL

0285-44-2130

Email

kkario@jichi.ac.jp

Name of contact person

1st name
Middle name
Last name	Satoshi Hoshide

Organization

Jichi Medical University School of Medicine

Division name

Division of Cardiovascular Medicine,

Zip code

Address

3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN

TEL

0285-44-2130

Homepage URL

Email

hoshide@jichi.ac.jp

Institute

Jichi Medical University School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

02

Month

03

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

Completed

Date of protocol fixation

2013

Year

12

Month

09

Day

Date of IRB

Anticipated trial start date

2014

Year

02

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

02

Month

03

Day

Last modified on

2017

Year

05

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015213