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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005281
Receipt No. 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

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

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
URL(English) https://upload.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


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