UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016247
Receipt number R000018854
Scientific Title Depressor and anti-inflammatory effects of angiotensin II receptor blockers in metabolic and/or hypertensive patients with coronary artery disease
Date of disclosure of the study information 2015/01/17
Last modified on 2016/08/14 20:19:25

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Basic information

Public title

Depressor and anti-inflammatory effects of angiotensin II receptor blockers in metabolic and/or hypertensive patients with coronary artery disease

Acronym

DIAMOND study

Scientific Title

Depressor and anti-inflammatory effects of angiotensin II receptor blockers in metabolic and/or hypertensive patients with coronary artery disease

Scientific Title:Acronym

DIAMOND study

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It is still controversial what types of angiotensin II type 1 receptor blockers (ARBs) are useful. We compare the efficacies (depressor effect and anti-inflammation) and safety of two kinds of ARBs (azilsartan vs. olmesartan) in patients with metabolic syndrome and/or hypertension who underwent coronary angiography. If the patients receive percutaneous coronary intervention, we assess depressor effect and in-stent restenosis at follow-up CAG.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Depressor effects and the percentage of patients who reach the target blood pressure.

Key secondary outcomes

1.Anti-inflammatory effects
2.Rate of in-stent restenosis


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The patients with hypertension who received ARBs except for azilsartan and olmesartan are enrolled. The patients are randomly divided into two groups (azilsartan and olmesartan groups) and treated for 12 weeks.

Interventions/Control_2

If the patient have percutaneous coronary intervention, we assess depressor effect and rate of in-stent restenosis at follow-up CAG.

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

1.Patients with hypertension who receive ARBs expect for azilsartan and olmesartan
2.Age is 20 years old or more.
3.Patients who undergo CAG
4.Patients who give their informed consent to participate for the present study.

Key exclusion criteria

1.Severe liver dysfunction.
2.Severe renal dysfunction.
3.Pregnancy or lactation in women.
4.Patients with a history of allergy to any component of the study medications.
5.Patients corresponding to the contraindication of study medications.
6.Ineligible patients according to the judgment by physician.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keijiro Saku

Organization

Fukuoka University School of Medicine

Division name

Department of Cardiology

Zip code


Address

7-45-1 Nanakuma, Jonan-Ku, Fukuoka.

TEL

81-92-801-1011

Email

saku-k@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shin-ichiro Miura

Organization

Fukuoka University School of Medicine

Division name

Department of Cardiology

Zip code


Address

7-45-1 Nanakuma, Jonan-Ku, Fukuoka.

TEL

81-92-801-1011

Homepage URL


Email

miuras@cis.fukuoka-u.ac.jp


Sponsor or person

Institute

Department of Cardiology, Fukuoka University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiology, Fukuoka University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

福岡大学病院(Fukuoka University Hospital)


Other administrative information

Date of disclosure of the study information

2015 Year 01 Month 17 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

2012 Year 12 Month 21 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 30 Day

Date trial data considered complete

2016 Year 04 Month 30 Day

Date analysis concluded

2016 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 01 Month 17 Day

Last modified on

2016 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=R000018854


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name