UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010266
Receipt number R000012017
Scientific Title Assessment of efficacy and safety profile of irbesartan/amlodipine single-pill combination drug in uncontrolled-hypertension with type 2 diabetic patients.
Date of disclosure of the study information 2013/03/18
Last modified on 2016/03/08 09:49:46

* 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

Assessment of efficacy and safety profile of irbesartan/amlodipine single-pill combination drug in uncontrolled-hypertension with type 2 diabetic patients.

Acronym

Aimix study

Scientific Title

Assessment of efficacy and safety profile of irbesartan/amlodipine single-pill combination drug in uncontrolled-hypertension with type 2 diabetic patients.

Scientific Title:Acronym

Aimix study

Region

Japan


Condition

Condition

Hypertension with type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Assessment of efficacy and safety profile of irbesartan/amlodipine single-pill combination drug in uncontrolled-hypertension with type 2 diabetic patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of the blood pressure on medical examination

Key secondary outcomes

Urinary albumin
Serum creatinine
eGFR
Serum uric acid
Serum potassium
HbA1c
Pntraxin3


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Switching ABR and CCB, which patients are already taking, to irbesartan/amlodipine single-pill combination drug. Other anti-hypertensive and anti-diabetic medications are maintained at the same dosage throughout the study.

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

The inclusion criteria are a baseline systolic blood pressure &#8805;130 or diastolic blood pressure &#8805;80 mmHg on medical examination in the patients who are taking antihypertensive agents, including ARB and CCB for more than one month.

Key exclusion criteria

The exclusion criteria are based on fulfillment of at least one of the following; 1) a past history of allergy of this medicine or dihydropyridine drugs; 2) pregnancy, possibility of pregnancy; 3) current treatment with corticosteroids and/or immnosuppressive drugs; 4) patients who judge that the physician is not suitable

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Daisuke Koya

Organization

Kanazawa Medical University Hospital

Division name

Endocrinology and Metabolism

Zip code


Address

Daigaku1-1 Uchinadamachi Kahokugun Ishikaw

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kanazawa Medical University Hospital

Division name

Endocrinology and Metabolism

Zip code


Address

Daigaku1-1 Uchinadamachi Kahokugun Ishikawa

TEL


Homepage URL


Email



Sponsor or person

Institute

Kanazawa Medical University
Diabetes and Endocrinology

Institute

Department

Personal name



Funding Source

Organization

Kanazawa Medical University
Diabetes and Endocrinology

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

2013 Year 03 Month 18 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 01 Month 22 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 06 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

2013 Year 03 Month 18 Day

Last modified on

2016 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012017


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name