UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010213 |
|---|---|
| Receipt number | R000011436 |
| Scientific Title | Effect of coadministration of angiotensin II receptor blocker (ARB) and calcium channel blocker (CCB) on variability of home blood pressure in hypertensive outpatients |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2020/09/15 16:20:08 |
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Basic information
Public title
Effect of coadministration of angiotensin II receptor blocker (ARB) and calcium channel blocker (CCB) on variability of home blood pressure in hypertensive outpatients
Acronym
Effect of ARB/CCB combination on home blood pressure variability
Scientific Title
Effect of coadministration of angiotensin II receptor blocker (ARB) and calcium channel blocker (CCB) on variability of home blood pressure in hypertensive outpatients
Scientific Title:Acronym
Effect of ARB/CCB combination on home blood pressure variability
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of ARB/CCB combination on variability of home blood pressure in outpatients with hypertension resistive to single administration of ARB or CCB
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of home blood pressure variability
Key secondary outcomes
1) Change of blood pressure at clinic and home
2) Change of pulse rate at clinic and home
3) Change of cardiac function (double product: pulse rate x systolic blood pressure)
4) Change of renal function (eGFR: estimated glomerular filtration rate)
5) Change of albuminuria
6) Incidence and degree of detrimental events
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
Change from olmesartan medoxomil 20mg/day or azelnidipine 16mg/day to coadministration of olmesartan medoxomil 20mg and azelnidipine 16mg per day for a period of 16 weeks
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) Hypertensive outpatients whose blood pressures show more than 135/85mmHg for the latest period of five consecutive days despite the administration of 16mg/day azelnidipine or 20mg/day olmesartan medoxomil for a period of more than four weeks
2) Patients who are able to measure home blood pressure on their own upper arms and to write the values down in the recording notebook
3) Patients with the informed consent to this study
Key exclusion criteria
1) Patients with the past history of hypersensitivity to test drugs, other ARBs or dihydropyridine CCBs
2) Female in current or expected pregnancy
3) Patients with the past history of cerebro-cardiovascular diseases within six months
4) Patients whose blood pressures show more than 180/110mmHg
5) Patients receiving the dialysis therapy or with severe renal dysfunction (eGFR<30ml/min/1.73m2)
6) Patients with severe hepatic dysfunction (showing more than 100 IU/L of AST or ALT)
7) Patients receiving treatment for a malignant neoplasm
8) Patients taking a contraindication drug for coadministration of test drugs
9) Patients judged as unsuitable for participating in this study by the attending physician
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Kashihara |
Organization
Kawasaki Medical School
Division name
Department of Nephrology and Hypertension
Zip code
7010192
Address
577 Matsushima, Kurashiki, Okayama 701-0192
TEL
086-462-1111
kashinao@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Nagasu |
Organization
Kawasaki Medical School
Division name
Department of Nephrology and Hypertension
Zip code
7010192
Address
577 Matsushima, Kurashiki, Okayama 701-0192
TEL
086-462-1111
Homepage URL
hajimenagasu@kms-ndh.com
Sponsor or person
Institute
Department of Nephrology and Hypertension, Kawasaki Medical School
Institute
Department
Personal name
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
Kawasaki Medical School
Address
577 Matsushima, Kurashiki, Okayama 701-0192
Tel
086-462-1111
kmsrec@med.kawasaki-m.ac.jp
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
| 2013 | Year | 04 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 12 | Day |
Last modified on
| 2020 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011436
