UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005281
Receipt number R000006279
Scientific Title Direct Renin Inhibitor decreases central systolic blood pressure.
Date of disclosure of the study information 2011/03/23
Last modified on 2012/09/24 08:56:16

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Basic information

Public title

Direct Renin Inhibitor decreases central systolic blood pressure.

Acronym

Direct Renin Inhibitor decreases central systolic blood pressure.

Scientific Title

Direct Renin Inhibitor decreases central systolic blood pressure.

Scientific Title:Acronym

Direct Renin Inhibitor decreases central systolic blood pressure.

Region

Japan


Condition

Condition

hypertensive patients

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examined the influence of a direct renin inhibitor, DRI, the influence on the central blood pressure(CBP).

Basic objectives2

Others

Basic objectives -Others

We divided patients who did not respond to standard-dose DRI administration into 2 groups: a group in which the dose was increased to a maximum, and a group in which standard-dose DRI was combined with diuretics, and examined the influence on the CBP.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Central blood pressure

Key secondary outcomes

The blood pressure, the aortic PWV, microalbuminuria, and high-sensitivity C-reactive protein (CRP) level.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


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

Essential hypertension who showed a systolic blood pressure of 140 mmHg or more after 12-week DRI administration at 150 mg/day. We employed the PROBE method, the subjects were assigned to receive an increased dose (300 mg) of DRI.

Interventions/Control_2

Essential hypertension who showed a systolic blood pressure of 140 mmHg or more after 12-week DRI administration at 150 mg/day. We employed the PROBE method, the subjects were assigned to receive a combination therapy with a diuretic, hydrochlorothiazide, at 12.5 mg.

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

Essential hypertension who showed a systolic blood pressure of 140 mmHg or more after 12-week DRI administration at 150 mg/day.

Key exclusion criteria

1) Secondary hypertension patients
2) Bilateral or unilateral renal arterial stenosis
3) Severe renal dysfunction requiring hemodialysis or peritoneal dialysis
4) Severe hepatopathy/nephropathy or heart disease that may affect the evaluation of drug safety
5) Patients who are deemed to be inappropriate by the investigator or sub-investigators

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiaki Kubota

Organization

Nippon Medical School Department of Medicine

Division name

Division of Cardiology, Hepatology, Geriatrics and Integrated Medicine

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo Japan 113-8603

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Nippon Medical School Department of Medicine

Division name

Division of Cardiology, Hepatology, Geriatrics and Integrated Medicine

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Nippon Medical School Department of Medicine
Division of Cardiology, Hepatology, Geriatrics and Integrated Medicine

Institute

Department

Personal name



Funding Source

Organization

Nippon Medical School Department of Medicine
Division of Cardiology, Hepatology, Geriatrics and Integrated Medicine

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

2011 Year 03 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


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

2010 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 04 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

2011 Year 03 Month 21 Day

Last modified on

2012 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006279


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name