UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005140 |
|---|---|
| Receipt number | R000006071 |
| Scientific Title | Evaluation of efficacy in improvement of cardiac function / renal function by REZALTAS COMBINATION TABLETS on hypertension patient. |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2013/02/28 10:50:24 |
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Basic information
Public title
Evaluation of efficacy in improvement of cardiac function / renal function by REZALTAS COMBINATION TABLETS on hypertension patient.
Acronym
Evaluation of efficacy of REZALTAS COMBINATION TABLETS on hypertension patient.
Scientific Title
Evaluation of efficacy in improvement of cardiac function / renal function by REZALTAS COMBINATION TABLETS on hypertension patient.
Scientific Title:Acronym
Evaluation of efficacy of REZALTAS COMBINATION TABLETS on hypertension patient.
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate of heart / renal protection effect and the changes such as home blood pressure / heart rate by changing it to REZALTAS on the patient that concomitant medication therapy of ARB / CCB is performed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of cardiac function.
Improvement of renal function.
Key secondary outcomes
BNP
MDA-LDL
renin
aldosterone
norepinephrine
home blood pressure in early morning
home heart rate in early morning
double product
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
olmesartan medoxomil 20mg
REZALTAS COMBINATION TABLETS
(olmesartan medoxomil 20mg, azelnidipine 16mg)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patient who can not control blood pressure by concomitant medication therapy on essential hypertension.
(systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg)
2)20 years old and more than it.
3)Informed consent.
Key exclusion criteria
1)Secondary hypertension
2)Known history of cerebral apoplexy.
3)Hyperkalemia (K>5.0mEq/L)
4)Serum Cr>3.0mg/dl
5)Severe hepatic disease.
6)Woman who are pregnant or woman of childbearing potential.
7)Patient who has olmesartan allergy or azelnidipine allergy.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Kawai |
Organization
Kanazawa Medical University Hospital
Division name
Department of Cardiology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Kawai |
Organization
Kanazawa Medical University Hospital
Division name
Department of Cardiology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
Homepage URL
kawai@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University Hospital
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
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 | 01 | 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
| 2010 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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 | 02 | Month | 25 | Day |
Last modified on
| 2013 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006071
