UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003458
Receipt number R000004183
Scientific Title effect of antihypertensive combination therapy with either CCB or diuretics on irbesartan on hypertensive patient with metabolic syndrome:A randomised controlled trial
Date of disclosure of the study information 2010/04/07
Last modified on 2014/08/14 16:51:12

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Basic information

Public title

effect of antihypertensive combination therapy with either CCB or diuretics on irbesartan on hypertensive patient with metabolic syndrome:A randomised controlled trial

Acronym

effect of antihypertensive combination therapy

Scientific Title

effect of antihypertensive combination therapy with either CCB or diuretics on irbesartan on hypertensive patient with metabolic syndrome:A randomised controlled trial

Scientific Title:Acronym

effect of antihypertensive combination therapy

Region

Japan


Condition

Condition

hypertensive patient with metabolic syndorome

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

effect of antihypertensive combination therapy with either CCB or diuretics on irbesartan on hypertensive patient with metabolic syndrome

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

degree and accomplishment of a BP recommended goal

Key secondary outcomes

clinical parameters
fasting glucose levels
HOMA-R
TG
HDL-C
LDL-C
u-albumin:creatinine ratio
e-GFR
ICAM-1


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

irbesartan(50-200mg)+amlodipine(2.5-10mg)/day

Interventions/Control_2

irbesartan(50-200mg)+indapamide(0.5-2mg)/day

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

hypertennsive patients with metabolic syndrome
1)Hypertention
ARB other than irbesartan have been administered for one month or more.
The home blood pressure value is SBP125mmHg or DBP75mmHg and above the value of the blood pressure of the examination room is SBP130mmHg or DBP80mmHg or more.
2)Patient who fill metabolic syndrome criteria standard

Key exclusion criteria

1)Hypersensitivity
2)Pregnant woman or possibility of pregnancy
3)Diuretic and CCB are administered
4)Steroid or the immunosuppressive agent is taken
5)Patient who judged that doctor in charge is improper

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Daisuke Koya

Organization

Kanazawa Medical University

Division name

Diabetes & Endocrinology

Zip code


Address

Daigaku1-1 Uchinadamachi Kahokugun Ishikawaken

TEL

076-286-2211

Email



Public contact

Name of contact person

1st name
Middle name
Last name Daisuke Koya

Organization

Kanazawa Medical University

Division name

Diabetes & Endocrinology

Zip code


Address

Daigaku1-1 Uchinadamachi Kahokugun Ishikawaken

TEL

076-286-2211

Homepage URL


Email

koya0516@kanazawa-med.ac.jp


Sponsor or person

Institute

Kanazawa Medical University
Diabetes & Endocrinology

Institute

Department

Personal name



Funding Source

Organization

Kanazawa Medical University
Diabetes & 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

2010 Year 04 Month 07 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

2009 Year 12 Month 21 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date

2011 Year 12 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

2010 Year 04 Month 07 Day

Last modified on

2014 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004183


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name