UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015323
Receipt number R000017807
Scientific Title The changes of renin, angiotensin and aldosterone with long term administration of olmesartan:COMPATIBLE extension study
Date of disclosure of the study information 2014/10/03
Last modified on 2018/08/28 15:23:19

* 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

The changes of renin, angiotensin and aldosterone with long term administration of olmesartan:COMPATIBLE extension study

Acronym

COMPATIBLE extension RAS study

Scientific Title

The changes of renin, angiotensin and aldosterone with long term administration of olmesartan:COMPATIBLE extension study

Scientific Title:Acronym

COMPATIBLE extension RAS study

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify the presence of aldosterone breakthrough or not after long term treatment with olmesartan. We found decreased aldosterone concentration after 3 months and 6 months treatment with olmesartan in COMPATIBLE study, but no available data presents for aldosterone concentration after long term treatment with ARBs over years. The change of aldosterone with long term treatment of ARB may add novel point of view in hypertension treatment.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Aldosterone concentration

Key secondary outcomes

Renin
Angiotensin I
Angiotensin II
Urinary albumin-to-creatinine ratio


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

Administration of Olmesartan

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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who were participants in the prior COMPATIBLE Study, and still takes Olmesartan at the same attended clinic.

Key exclusion criteria

The patient who do not take Olmesartan.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisao Mori

Organization

Kanagawa Association of Medical and Dental Practitioners

Division name

Department of Clinical Research

Zip code


Address

TS plaza bldg 2 F, 2-23-2, tsuruya-Cho, Kanagawa-Ku, Yokohama, Japan

TEL

045-313-2111

Email

hmori@gem.hi-ho.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisao Mori

Organization

Kanagawa Association of Medical and Dental Practitioners

Division name

Department of Clinical Research

Zip code


Address

TS plaza bldg 2 F, 2-23-2, tsuruya-Cho, Kanagawa-Ku, Yokohama, Japan

TEL

045-313-2111

Homepage URL


Email

hmori@gem.hi-ho.ne.jp


Sponsor or person

Institute

Kanagawa Association of Medical and Dental Practitioners

Institute

Department

Personal name



Funding Source

Organization

DAIICHI SANKYO CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

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 10 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

2014 Year 07 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 01 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 10 Month 02 Day

Last modified on

2018 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017807


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name