UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013050
Receipt number R000015213
Scientific Title Angiotensin receptor blocker/Calcium antagonist combination therapy on diurnal blood pressure variation
Date of disclosure of the study information 2014/02/03
Last modified on 2017/05/30 14:12:49

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

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

Condition

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

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.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Jichi Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 03 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name