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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004750
Receipt No. R000005655
Scientific Title The study of efficacy of AT1 receptor blocker, olmesartan and calcium antagonists , azelnidipine combination therapy in patients with essential hypertension , diabetic or chronic kidney disease
Date of disclosure of the study information 2010/12/18
Last modified on 2012/01/18

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Basic information
Public title The study of efficacy of AT1 receptor blocker, olmesartan and calcium antagonists ,
azelnidipine combination therapy in patients with essential hypertension , diabetic or chronic kidney disease
Acronym The study of efficacy of AT1 receptor blocker, olmesartan and calcium antagonists ,
azelnidipine combination therapy in patients with essential hypertension , diabetic or chronic kidney disease
(HARIMAYA study)
Scientific Title The study of efficacy of AT1 receptor blocker, olmesartan and calcium antagonists ,
azelnidipine combination therapy in patients with essential hypertension , diabetic or chronic kidney disease
Scientific Title:Acronym The study of efficacy of AT1 receptor blocker, olmesartan and calcium antagonists ,
azelnidipine combination therapy in patients with essential hypertension , diabetic or chronic kidney disease
(HARIMAYA study)
Region
Japan

Condition
Condition Patient with essential hypertension, diabetic or chronic kidney disease
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is a purpose to confirm the antihypertensive effect and safety of olmesartan and azelnidipine combination therapy in patients with essential hypertension , diabetic or chronic kidney disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The change from baseline in BP
(office blood pressure, home blood pressure)
The proportion of patients achieving the BP goal provided by the guideline for the management of hypertension in Japan
Key secondary outcomes The change from baseline of protein in urine and eGFR

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 It changes from therapy of conventional dose of ARB or CCB to combination therapy of olmesartan (20mg/day) and azelnidipine (16mg/day).
Target blood pressure (BP) is under 130/80 mmHg
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with essential hypertension , diabetic or chronic kidney disease.
Patients are taking conventional dose of AT1 receptor blocker or calcium antagonists.
SBP/DBP > 130/80mmHg

Patients who meets the above-mentioned requirement.
Key exclusion criteria SCr > 3.0mg/dl
Patient has liver dysfunction.
It is a developing patient within six months as for cardiac infarction or the apoplexy.
Patient who has possibility of pregnancy or pregnancy.
Patient while suckling.
Patient who judged that doctor is improper
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Terada
Organization Kochi Medical School
Division name Department of Endocrinology, Metabolism and Nephrology
Zip code
Address Kohasu, Oko-cho, Nankoku, Japan
TEL 088-880-2343
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koji Ogata
Organization Kochi Medical School
Division name Department of Endocrinology, Metabolism and Nephrology
Zip code
Address Kohasu, Oko-cho, Nankoku, Japan
TEL 088-880-2343
Homepage URL
Email b08d6b06@s.kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
Institute
Department

Funding Source
Organization None
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 12 Month 18 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 Enrolling by invitation
Date of protocol fixation
2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2012 Year 03 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 12 Month 18 Day
Last modified on
2012 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005655

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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